United States · Requirement analysis
Document the medical-device quality management system
21 CFR 820.10 · 820.10(a)
Manufacturers subject to Part 820 under section 820.1(a).
Source checked 2026-10-20
Center for International Standards Research
Requirements Research
Examine specific legal provisions and the adoption or use of standards across markets.
Requirement analyses address identified legal provisions. Standards relationships examine national adoption, legal incorporation, designation or harmonization, and programme recognition. A relationship record is not a reproduction of a private standard’s technical clauses.
220 research records
United States · Requirement analysis
Identify the finished-product certifier
16 CFR 1110.7 · 1110.7(a)-(b)
Finished products that require a certificate under section 1110.5.
Source checked 2026-10-20
United States · Requirement analysis
Clear the applicable authorization route before radio-device marketing
47 CFR 2.803 · 2.803(a)-(b), (d)
Persons marketing radiofrequency devices within the rule definition.
Source checked 2026-10-20
United States · Requirement analysis
Maintain a written food recall plan when preventive controls are required
21 CFR 117.139 · 117.139(a)-(b)
Food with a hazard requiring a preventive control at a facility subject to the relevant Part 117 provisions.
Source checked 2026-10-20
United States · Requirement analysis
Label finished goods containing regulated composite wood
40 CFR 770.45 · 770.45(c)-(f)
Fabricators of finished goods containing regulated composite wood, and downstream importers, distributors and retailers.
Source checked 2026-10-20
United States · Requirement analysis
Make the lithium battery test summary available
49 CFR 173.185 · 173.185(a)(3)
Manufacturers and subsequent distributors of covered lithium cells and batteries manufactured on or after 1 January 2008.
Source checked 2026-10-20
United States · Standards relationship
ISO 13485:2016 is incorporated into the FDA device quality framework
21 CFR 820.7(b) · 820.7(b)
The provisions of Part 820 for which FDA approves incorporation by reference.
Source checked 2026-10-20
United States · Standards relationship
ASTM F963-23 supplies the incorporated US toy-safety requirements
16 CFR 1250.2 · 1250.2(a)-(b)
Toys and applicable provisions within Part 1250.
Source checked 2026-10-20
United States · Standards relationship
US lithium transport rules refer to UN subsection 38.3
49 CFR 171.7 and 173.185 · 171.7(dd)(2); 173.185(a)(1)-(2)
Lithium cell and battery types offered for transport under the cited US rule.
Source checked 2026-10-20
United States · Standards relationship
UL 62368-1 appears on OSHA’s appropriate NRTL test-standard list
UL 62368-1 appears on OSHA’s appropriate NRTL test-standard list · UL 62368-1 list entry; 29 CFR 1910.7 framework
Product certification within the NRTL programme and an individual laboratory’s recognized standard and site scope.
Source checked 2026-10-20
European Union · Requirement analysis
Prepare the GPSR risk analysis and technical documentation
Regulation (EU) 2023/988 · Article 9(2)
Manufacturers placing products within the GPSR scope on the Union market.
Source checked 2026-10-20
European Union · Requirement analysis
Document and assess radio equipment before CE marking
Directive 2014/53/EU · Article 10(3), referring to Articles 17 and 21
Manufacturers of radio equipment covered by the Radio Equipment Directive.
Source checked 2026-10-20
European Union · Requirement analysis
Maintain a device QMS proportionate to device risk and type
Regulation (EU) 2017/745 · Article 10(9)
Manufacturers of devices within MDR scope other than investigational devices, subject to applicable arrangements.
Source checked 2026-10-20
European Union · Requirement analysis
Communicate Candidate List substance information for articles
Regulation (EC) 1907/2006 (REACH) · Article 33(1)-(2)
Suppliers of articles containing a Candidate List substance above 0.1% weight by weight.
Source checked 2026-10-20
European Union · Requirement analysis
Provide food information before a distance-sale purchase
Regulation (EU) 1169/2011 · Article 14(1), (3)
Prepacked food offered through distance communication.
Source checked 2026-10-20
European Union · Requirement analysis
Document performance values for the specified rechargeable batteries
Regulation (EU) 2023/1542 · Article 10(1); Annex IV
Rechargeable industrial batteries above 2 kWh, LMT batteries and electric-vehicle batteries.
Source checked 2026-10-20
European Union · Standards relationship
EN ISO 13485 has a defined MDR harmonised-reference role
Implementing Decision (EU) 2021/1182 · Annex entry 10; MDR Article 8(1)
MDR requirements covered by the cited harmonised standard or relevant parts.
Source checked 2026-10-20
European Union · Standards relationship
The EN 60335-1 appliance reference carries an express restriction
Implementing Decision (EU) 2025/1457 · Annex point (2), row 155a
Safety objectives under Directive 2014/35/EU covered by the published appliance reference.
Source checked 2026-10-20
European Union · Standards relationship
EN ISO 12100 is an A-type machinery reference, not a complete presumption
Implementing Decision (EU) 2023/1586 · Annex I, Part One, points 1-2
Machinery assessed under Directive 2006/42/EC while that directive applies.
Source checked 2026-10-20
European Union · Standards relationship
EN ISO 14971 is listed for the MDR risk-management route
Implementing Decision (EU) 2021/1182, entry 16 · Annex entry 16; MDR Article 8
MDR requirements covered by the harmonised risk-management reference.
Source checked 2026-10-20
United Kingdom · Requirement analysis
Place only safe products on the Great Britain market
General Product Safety Regulations 2005, SI 2005/1803 · Regulation 5(1)-(4)
Producers and products within the Great Britain general product-safety regime.
Source checked 2026-10-20
United Kingdom · Requirement analysis
Keep electrical-equipment documentation available for ten years
Electrical Equipment (Safety) Regulations 2016, SI 2016/1101 · Regulation 7
Manufacturers of covered electrical equipment under the applicable Great Britain regime.
Source checked 2026-10-20
United Kingdom · Requirement analysis
Check that radio equipment can operate within spectrum requirements
Radio Equipment Regulations 2017, SI 2017/1206 · Regulation 8, Great Britain version
Manufacturers placing covered radio equipment on the Great Britain market.
Source checked 2026-10-20
United Kingdom · Requirement analysis
Notify the enforcement authority of an unsafe supplied product
General Product Safety Regulations 2005, SI 2005/1803 · Regulation 9(1)-(4), Great Britain version
Producers or distributors within the Great Britain GPSR scope who know that a marketed or supplied product poses risks incompatible with the general safety requirement.
Source checked 2026-10-20
United Kingdom · Requirement analysis
Register the relevant general medical device before Great Britain placement
Medical Devices Regulations 2002, SI 2002/618 · Regulation 7A(1)-(2A)
Relevant general medical devices placed under Part II in Great Britain, with role-specific registration arrangements.
Source checked 2026-10-20
United Kingdom · Requirement analysis
Draw up the construction-product declaration of performance when triggered
Assimilated Construction Products Regulation, Regulation (EU) 305/2011 · Article 4(1)-(3), UK-amended text
Construction products covered by a designated standard or conforming to an issued UK Technical Assessment under the Great Britain route.
Source checked 2026-10-20
United Kingdom · Standards relationship
Great Britain designates the EN 62368-1:2014 ICT safety reference
Low voltage designated standards notice 0120/25 · Annex I complete list, entry 557
Covered electrical equipment and the safety objectives addressed under SI 2016/1101 in Great Britain.
Source checked 2026-10-20
United Kingdom · Standards relationship
Great Britain lists EN ISO 12100 as an A-type machinery reference
Machinery designated standards notice 0139/26 · Annex I Part 2, A-type standards
Machinery within the Supply of Machinery (Safety) Regulations 2008 in Great Britain.
Source checked 2026-10-20
United Kingdom · Standards relationship
The Great Britain glove reference includes the 2024 European amendment
PPE designated standards notice 0142/26 · Annex I complete list, entry 200
Protective gloves and the essential requirements covered by the designated reference in Great Britain.
Source checked 2026-10-20
United Kingdom · Standards relationship
Great Britain’s device list identifies an EN ISO 13485 package
Medical-device designated standards notice 0129/26 · Annex I, entry 126
Designated-standard use supporting the UK Medical Devices Regulations 2002 in Great Britain.
Source checked 2026-10-20
Germany · Requirement analysis
Register electrical equipment by type and brand before German placement
Electrical and Electronic Equipment Act (ElektroG) · Section 6(1)-(3)
Manufacturers or relevant authorized representatives placing covered electrical/electronic equipment on the German market.
Source checked 2026-10-20
Germany · Requirement analysis
Register the packaging producer under the current German implementing law
Packaging Law Implementation Act (VerpackDG) · Section 6(1)-(3)
Producers identified through the referenced EU 2025/40 definitions, at the German first-making-available or unpacking trigger specified in section 6.
Source checked 2026-10-20
Germany · Requirement analysis
Assess workplace equipment risks before use, even with CE marking
Industrial Safety and Health Ordinance (BetrSichV) · Section 3(1)-(4), (8)
Employers using work equipment within BetrSichV scope.
Source checked 2026-10-20
Germany · Requirement analysis
Inspect installation-dependent work equipment before use
Industrial Safety and Health Ordinance (BetrSichV) · Section 14(1), (7)-(8)
Employers using equipment whose safety depends on installation conditions.
Source checked 2026-10-20
Germany · Requirement analysis
Provide understandable hazardous-substance instructions and training
Hazardous Substances Ordinance (GefStoffV) · Section 14(1)-(2)
Employers with employees working with hazardous substances within the ordinance scope.
Source checked 2026-10-20
Germany · Requirement analysis
Report suspected serious device incidents from professional use
Medical Device User Reporting and Information Ordinance (MPAMIV) · Section 3
Persons operating or using covered devices professionally or commercially, and physicians or dentists learning of suspected serious incidents in professional work.
Source checked 2026-10-20
Germany · Standards relationship
DIN identifies its national EN ISO 9001:2015 publication and amendment
DIN EN ISO 9001:2015-11 · Official national publication identity
Bibliographic identification of the German and English national version of EN ISO 9001:2015.
Source checked 2026-10-20
Germany · Standards relationship
DIN’s medical QMS publication implements the European amendment package
DIN EN ISO 13485:2021-12 · Official national publication identity
National publication identification for the German version of the named European medical-device QMS package.
Source checked 2026-10-20
Germany · Standards relationship
DIN EN ISO 12100:2011-03 identifies the German version of EN ISO 12100:2010
DIN EN ISO 12100:2011-03 · Official national publication identity
Bibliographic use of the German national publication of the machinery risk-assessment reference.
Source checked 2026-10-20
Germany · Standards relationship
DAkkS uses DIN EN ISO/IEC 17025 for testing-laboratory accreditation
DAkkS rule R-17025-PL · R-17025-PL introduction and scope
Testing laboratories applying for or holding accreditation within the DAkkS framework.
Source checked 2026-10-20
France · Requirement analysis
Declare a French product recall through the national public system
Consumer Code (Code de la consommation) · Article L423-3
Economic operators implementing product recalls; the article separately addresses food and feed recalls.
Source checked 2026-10-20
France · Requirement analysis
Provide French-language product and commercial information
French Language Law No. 94-665 of 4 August 1994 · Article 2
Product or service designation, offers, presentation, instructions, guarantees, invoices, receipts and advertising covered by Article 2.
Source checked 2026-10-20
France · Requirement analysis
Register the producer for the relevant French EPR stream
Environmental Code (Code de l’environnement) · Article L541-10-13
Producers within an extended-producer-responsibility stream under Article L541-10.
Source checked 2026-10-20
France · Requirement analysis
Provide sorting information for covered household products
Environmental Code (Code de l’environnement) · Article L541-9-3
Household products subject to the referenced French EPR provision.
Source checked 2026-10-20
France · Requirement analysis
Report a serious device incident known to a professional user
Public Health Code (Code de la santé publique) · Article L5212-2, second paragraph
Health professionals and professional device users who know of a serious incident.
Source checked 2026-10-20
France · Requirement analysis
Renew equipment safety training when equipment evolves
Labour Code (Code du travail) · Article R4323-3
Workers responsible for using or maintaining workplace equipment.
Source checked 2026-10-20
France · Standards relationship
AFNOR identifies a September 2026 NF EN ISO 9001 publication
NF EN ISO 9001, AFNOR catalogue record FA208830/605440 · National publication and European relationship metadata
Identification of the French national publication and its European parent.
Source checked 2026-10-20
France · Standards relationship
The French medical QMS publication has a separate A11 amendment
NF EN ISO 13485 and NF EN ISO 13485/A11 · National publication and European relationship metadata
Identification of the French base publication and European amendment relationship.
Source checked 2026-10-20
France · Standards relationship
NF EN ISO 12100 identifies the French national machinery reference
NF EN ISO 12100, December 2010 · National publication and parent metadata
Identification of the French national version of the stated machinery reference.
Source checked 2026-10-20
France · Standards relationship
Cofrac uses NF EN ISO/IEC 17025 in laboratory accreditation
Cofrac LAB REF 02 · Reference framework for testing and calibration laboratory accreditation
Laboratories assessed within the Cofrac testing/calibration accreditation framework.
Source checked 2026-10-20
Switzerland · Requirement analysis
Apply the Swiss subsidiary product-safety requirements
Federal Act on Product Safety (PrSG), SR 930.11 · Article 3(1)-(4), (6)
Manufacturers and subsidiary responsible importers, traders or service providers within the Act’s scope.
Source checked 2026-10-20
Switzerland · Requirement analysis
Keep an up-to-date low-voltage declaration of conformity
Ordinance on Low-Voltage Electrical Equipment (NEV), SR 734.26 · Article 8(1)-(5)
Economic operators making covered low-voltage equipment available, with the stated conditional fulfilment-provider arrangement.
Source checked 2026-10-20
Switzerland · Requirement analysis
Prepare the Swiss EMC declaration under the applicable ordinance
Ordinance on Electromagnetic Compatibility (VEMV), SR 734.5 · Article 11(1)-(3)
Manufacturers or authorized persons issuing declarations for covered EMC apparatus.
Source checked 2026-10-20
Switzerland · Requirement analysis
Appoint a Swiss device representative through a written mandate
Medical Devices Ordinance (MepV/MedDO), SR 812.213 · Article 51(1)-(3bis)
Manufacturers domiciled outside Switzerland placing covered devices on the Swiss market.
Source checked 2026-10-20
Switzerland · Requirement analysis
Complete chemical self-control before first Swiss supply or own use
Chemicals Ordinance (ChemV), SR 813.11 · Article 5(1), (4)-(5)
Responsible manufacturers and commercial/professional importers of substances, preparations and relevant articles.
Source checked 2026-10-20
Switzerland · Requirement analysis
Provide Swiss food information for distance sales
Foodstuffs and Utility Articles Ordinance (LGV), SR 817.02 · Article 44(1), (3)
Prepacked foods offered using distance-communication techniques.
Source checked 2026-10-20
Switzerland · Standards relationship
Testing laboratories use the SAS ISO/IEC 17025 assessment framework
SAS testing-laboratory reference document 302 · Programme reference identity and scope
Testing-laboratory accreditation under the SAS programme.
Source checked 2026-10-20
Switzerland · Standards relationship
SAS identifies ISO/IEC 17020 for inspection-body assessment
SAS inspection-body reference document 602 · Programme reference identity and scope
Inspection bodies assessed under the published SAS inspection programme reference.
Source checked 2026-10-20
Switzerland · Standards relationship
SAS uses ISO/IEC 17065 for product-certification-body accreditation
SAS product-certification reference document 502 · Programme reference identity and scope
Bodies certifying products, processes or services under the SAS programme.
Source checked 2026-10-20
Switzerland · Standards relationship
SAS’s medical-laboratory route uses ISO 15189:2022
SAS medical-laboratory accreditation transition rules · Programme reference identity and scope
Medical laboratories within the SAS medical-testing accreditation programme.
Source checked 2026-10-20
Canada · Requirement analysis
Do not manufacture, import, advertise or sell a dangerous consumer product
Canada Consumer Product Safety Act, SC 2010 c 21 · Section 7(a)
Manufacturers and importers of consumer products within CCPSA scope.
Source checked 2026-10-20
Canada · Requirement analysis
Report a consumer-product incident within the statutory periods
Canada Consumer Product Safety Act, SC 2010 c 21 · Section 14(1)-(3)
Commercial manufacturers, importers and sellers that become aware of a statutory incident; the extended report has a narrower responsible role.
Source checked 2026-10-20
Canada · Requirement analysis
Meet the applicable radio certificate and technical-standard requirements
Radiocommunication Act, RSC 1985 c R-2 · Section 4(2)-(3)
Persons carrying out the listed commercial activities for radio apparatus or other equipment covered by the respective certificate or standard trigger.
Source checked 2026-10-20
Canada · Requirement analysis
Check the device-specific licence before importing or selling higher-class devices
Medical Devices Regulations, SOR/98-282 · Section 26
Import or sale of Class II, III or IV medical devices under the selected Part 1 provision.
Source checked 2026-10-20
Canada · Requirement analysis
Keep the prescribed food traceability documents accessible in Canada
Safe Food for Canadians Regulations, SOR/2018-108 · Section 90(1)-(3)
The specified interprovincial/import/export and licensed food activities, plus retail sellers under subsection (2).
Source checked 2026-10-20
Canada · Requirement analysis
Keep required consumer-chemical container information bilingual and legible
Consumer Chemicals and Containers Regulations, 2001, SOR/2001-269 · Section 17
Information required by these Regulations on covered consumer-chemical containers.
Source checked 2026-10-20
Canada · Standards relationship
Canadian device licensing refers to CAN/CSA-ISO 13485 as amended
Medical Devices Regulations, SOR/98-282 · Sections 32(2)(f), 32(3)(j), 32(4)(p)
QMS certificate information in the specified Class II, III and IV device licence applications.
Source checked 2026-10-20
Canada · Standards relationship
Health Canada recognizes an undated IEC 60601-1 reference under its version policy
Health Canada List of recognized standards for medical devices · Electromedical: IEC 60601-1; version-recognition guidance
Voluntary standards evidence supporting relevant medical-device safety/effectiveness requirements.
Source checked 2026-10-20
Canada · Standards relationship
RSS-247 requires RSS-Gen alongside the product-specific radio rules
ISED RSS-247 · Sections 2.1-2.5
Category I radio equipment within the frequency and system scopes stated by RSS-247.
Source checked 2026-10-20
Canada · Standards relationship
Ontario adopts CSA C22.1:24 with its own amendments
Ontario Regulation 164/99, Electrical Safety Code · Sections 1-2
Electrical activities within Ontario under the provincial regulation.
Source checked 2026-10-20
China · Requirement analysis
Mandatory standards as a production and market-entry boundary
Standardization Law of the People's Republic of China · Article 25, read with Article 2
Products or services subject to an applicable Chinese mandatory standard.
Source checked 2026-10-20
China · Requirement analysis
CCC controls before covered products leave the factory or enter commerce
Provisions on the Administration of Compulsory Product Certification · Article 2; catalogue and applicable implementation rules
Products actually included in the compulsory certification catalogue and within the relevant implementation rule.
Source checked 2026-10-20
China · Requirement analysis
Device production must follow the operating QMS and product technical requirements
Regulations for the Supervision and Administration of Medical Devices · Article 35
Medical-device registrants, filing holders and entrusted manufacturing enterprises within Article 35.
Source checked 2026-10-20
China · Requirement analysis
Prepackaged food must carry the legally required label particulars
Food Safety Law of the People's Republic of China · Article 67
Prepackaged food supplied within the Food Safety Law and the applicable food-safety standards.
Source checked 2026-10-20
China · Requirement analysis
Hazardous-substance information for electrical and electronic products
Measures for the Administration of the Restricted Use of Hazardous Substances in Electrical and Electronic Products · Article 13, read with Articles 2-3
Producers and importers placing electrical and electronic products within the defined scope on the Chinese market.
Source checked 2026-10-20
China · Requirement analysis
Recall plans must be reported through the applicable ten-working-day route
Interim Provisions on the Administration of Consumer Product Recalls · Article 17, read with Article 18
Producers conducting a consumer-product recall under these provisions; Article 29 also addresses imported goods.
Source checked 2026-10-20
China · Standards relationship
Medical-device QMS: the national adoption is ISO 13485:2016
Official national-standard catalogue record for GB/T 42061-2022
The named Chinese publication and its officially recorded international-source relationship.
Source checked 2026-10-20
China · Standards relationship
Medical electrical safety: a modified IEC 60601-1 adoption
Official national-standard catalogue record for GB 9706.1-2020
The named Chinese publication and its officially recorded international-source relationship.
Source checked 2026-10-20
China · Standards relationship
Laboratory competence: the Chinese adoption of ISO/IEC 17025
Official national-standard catalogue record for GB/T 27025-2019
The named Chinese publication and its officially recorded international-source relationship.
Source checked 2026-10-20
China · Standards relationship
Quality management: Chinese and international edition identity
Official national-standard catalogue record for GB/T 19001-2016
The named Chinese publication and its officially recorded international-source relationship.
Source checked 2026-10-20
Japan · Requirement analysis
DENAN technical conformity attaches to the notified product type
Electrical Appliances and Materials Safety Act · Article 8(1)
Notifying manufacturers or importers manufacturing or importing electrical appliances and materials of the notified type.
Source checked 2026-10-20
Japan · Requirement analysis
DENAN inspections require usable retained records
Electrical Appliances and Materials Safety Act and its enforcement requirements · Article 8(2); enforcement ordinance Article 11(2)-(3)
Notifying manufacturers and importers of covered appliances and materials, subject to the Article 8 exceptions.
Source checked 2026-10-20
Japan · Requirement analysis
Covered electrical products cannot be sold or displayed for sale without the lawful PSE indication
Electrical Appliances and Materials Safety Act · Article 27(1)-(2), with Article 10
Businesses manufacturing, importing or selling covered electrical appliances and materials.
Source checked 2026-10-20
Japan · Requirement analysis
PSC specified products require inspection records as well as technical conformity
Consumer Product Safety Act · Article 11(1)-(3)
Notifying businesses manufacturing or importing specified products of the notified type.
Source checked 2026-10-20
Japan · Requirement analysis
Radio-station licensing and conformity-based exceptions must be separated
Radio Act · Article 4
A person intending to establish a radio station in Japan.
Source checked 2026-10-20
Japan · Requirement analysis
Food businesses may sell only food labelled to the operative Food Labeling Standards
Food Labeling Act · Article 5, read with Article 4
Persons engaged in food-related business and other persons within the Act's scope selling food.
Source checked 2026-10-20
Japan · Standards relationship
JNLA laboratory registration uses ISO/IEC 17025 for the registered testing scope
NITE JNLA official programme requirements
Laboratories seeking or maintaining JNLA registration for the relevant JIS testing-method categories.
Source checked 2026-10-20
Japan · Standards relationship
DENAN Appendix 12 offers a specific household-appliance standards route
METI Interpretation of Technical Requirements: standards based on international standards
The applicable household-appliance technical route under the DENAN interpretation, with the relevant particular standard and national conditions.
Source checked 2026-10-20
Japan · Standards relationship
A central-monitor software review distinguishes patient-environment safety references
PMDA medical-device standards database: central-monitor software
The specifically described central-monitor software review guideline and its patient-environment distinctions.
Source checked 2026-10-20
Japan · Standards relationship
Neuroendoscope approval criteria use the Japanese medical-device risk-management reference
Revision of Neuroendoscope Approval Criteria
The neuroendoscope approval criteria and the device scope defined in that notification.
Source checked 2026-10-20
Australia · Requirement analysis
Do not supply consumer goods that fail an applicable mandatory safety standard
Australian Consumer Law · Section 106(1)
A person supplying consumer goods in trade or commerce to which a safety standard applies.
Source checked 2026-10-20
Australia · Requirement analysis
Small-child toys must follow one of the permitted post-transition compliance routes
Consumer Goods (Toys for Children up to and including 36 Months of Age) Safety Standard 2023 · Section 9, read with sections 6 and 19
Toys manufactured, designed, labelled or marketed for children up to and including 36 months, within section 6.
Source checked 2026-10-20
Australia · Requirement analysis
Consumer-accessible button-battery compartments must resist opening by young children
Consumer Goods (Products Containing Button/Coin Batteries) Safety Standard 2020 · Section 9, with sections 6 and 13-17
Covered consumer goods containing button/coin batteries that are accessible to the consumer.
Source checked 2026-10-20
Australia · Requirement analysis
A covered radio device needs the applicable declaration before compliance labelling
Radiocommunications Equipment (General) Rules 2021 · Schedule 3, clause 9, within the labelling requirements
Manufacturers or importers applying a label to a device for which Schedule 3 imposes the relevant pre-labelling requirements.
Source checked 2026-10-20
Australia · Requirement analysis
An ARTG sponsor must control medical-device storage and transport
Therapeutic Goods (Medical Devices) Regulations 2002 · Regulation 5.9
The person in relation to whom the kind of medical device is included in the ARTG, while that person controls a device of that kind.
Source checked 2026-10-20
Australia · Requirement analysis
Retail packaged food needs a label unless a specific exception applies
Australia New Zealand Food Standards Code, Standard 1.2.1 · Section 1.2.1-6(1), with sections 1.2.1-8 and 1.2.1-9
Packaged food for retail sale and food sold as suitable for retail sale without further processing, packaging or labelling.
Source checked 2026-10-20
Australia · Standards relationship
Australian toy law selects AS/NZS ISO 8124.1:2023 with statutory modifications
Small-child toy safety instrument: Australian/New Zealand route
The section 10 route selected under section 9 for covered small-child toys.
Source checked 2026-10-20
Australia · Standards relationship
The button-battery rule gives a limited AS/NZS 62368.1:2018 access-protection route
Button/coin-battery product safety instrument: audio/video and ICT route
The selected audio/video or electronic-apparatus route for section 9 battery-compartment resistance.
Source checked 2026-10-20
Australia · Standards relationship
Queensland combines the relevant product standard with AS/NZS 3820
Queensland electrical equipment safety: relevant standard
Electrical equipment in the Queensland relevant-standard framework described by the regulator.
Source checked 2026-10-20
Australia · Standards relationship
WaterMark assigns AS 3718:2021 to defined tapware categories
WaterMark Certification Scheme, Schedule of Products
Tapware and tap-accessory types within the specified WaterMark schedule entry.
Source checked 2026-10-20
New Zealand · Requirement analysis
Small-child toys supplied in trade must meet the New Zealand choking-hazard rule
Product Safety Standards (Children's Toys) Regulations 2005 · Regulation 5 and Schedule 2; Fair Trading Act section 30
Toys for children up to and including 36 months, including toys also used by older children.
Source checked 2026-10-20
New Zealand · Requirement analysis
Children's nightwear needs the correct permanent fire-hazard information
Product Safety Standards (Children's Nightwear and Limited Daywear Having Reduced Fire Hazard) Regulations 2016 · Regulation 6, with regulations 3 and 5; Fair Trading Act section 30
Covered children's nightwear and limited daywear, including relevant new and used garments.
Source checked 2026-10-20
New Zealand · Requirement analysis
Household cots have different selected provisions for new and second-hand supply
Product Safety Standards (Household Cots) Regulations 2005 · Regulations 4-5 and Schedule; Fair Trading Act section 30
Free-standing household cots within the regulation, supplied within the Fair Trading Act trade scope.
Source checked 2026-10-20
New Zealand · Requirement analysis
Declared medium-risk electrical articles require the New Zealand declaration route
Electricity (Safety) Regulations 2010 · Regulation 83, read with recognised alternative routes
Declared medium-risk articles and the New Zealand manufacturer or importer responsible for their sale.
Source checked 2026-10-20
New Zealand · Requirement analysis
A licence to supply radio transmitters is distinct from permission to operate them
Radiocommunications Regulations 2001 · Regulation 16, with regulations 18-19
Persons supplying radio transmitters to which the licensing requirement applies.
Source checked 2026-10-20
New Zealand · Requirement analysis
A food trader's primary duty is food that is safe and suitable
Food Act 2014 · Section 14, with the Act's safe and suitable definitions
A person who trades in food within the Food Act.
Source checked 2026-10-20
New Zealand · Standards relationship
New Zealand toy law retains a selected 2002 joint-standard reference
New Zealand product-specific regulation incorporating AS/NZS ISO 8124.1:2002
Selected choking-hazard provisions for the toys covered by the 2005 regulations.
Source checked 2026-10-20
New Zealand · Standards relationship
The New Zealand nightwear regulation selects AS/NZS 1249:2014
New Zealand product-specific regulation incorporating AS/NZS 1249:2014
Children's nightwear and limited daywear within the 2016 regulations.
Source checked 2026-10-20
New Zealand · Standards relationship
The cot regulation incorporates a modified subset of AS/NZS 2172:2003
New Zealand product-specific regulation incorporating AS/NZS 2172:2003
Household cots within regulation 4; different subsets for new and second-hand cots.
Source checked 2026-10-20
New Zealand · Standards relationship
New Zealand's 2025 electrical update specifies IEC/AS-NZS appliance combinations and a transition
Electricity (Safety) Amendment Regulations 2025
The particular household-appliance entries in the amended Schedule 4, with the standard A/B and particular-standard combinations stated there.
Source checked 2026-10-20
India · Requirement analysis
A compulsory BIS duty needs a section 16 notification, not merely an Indian Standard title
Bureau of Indian Standards Act 2016 · Section 17(1), read with section 16(1)
Goods, articles, processes, systems or services actually brought within a section 16 compulsory notification.
Source checked 2026-10-20
India · Requirement analysis
Toy QCO conformity and marking remain product-specific, including the 2026 permission route
Toys (Quality Control) Order 2020 and Transition Facilitation (Quality Control) Order 2026 · Toy Order paragraph 3; 2026 Order paragraphs 2-4 and Schedule
Covered toys designed or clearly intended for play by children under 14, subject to the operative exclusions and permitted routes.
Source checked 2026-10-20
India · Requirement analysis
Medical-device standard selection follows the Rule 7 hierarchy
Medical Devices Rules 2017 · Rule 7, as explained in CDSCO FAQ questions 25-26
Medical devices within the Indian Medical Devices Rules, with the relevant product standard selected for the device.
Source checked 2026-10-20
India · Requirement analysis
The front-of-pack food name must convey the product's true nature
Food Safety and Standards (Labelling and Display) Regulations 2020 · Regulation 5(1)
Prepackaged food within the regulation's labelling scope.
Source checked 2026-10-20
India · Requirement analysis
A retail package must identify the legally responsible manufacturer, packer or importer
Legal Metrology (Packaged Commodities) Rules 2011 · Rule 6(1)(a)
Packages falling within the retail packaged-commodity rules, subject to their application provisions.
Source checked 2026-10-20
India · Requirement analysis
Imported cosmetics require registration before import unless a specific exception applies
Cosmetics Rules 2020 · Rule 12(1)
Cosmetics imported into India that fall within Rule 12.
Source checked 2026-10-20
India · Standards relationship
BIS identifies IS/ISO 13485:2016 as an identical adoption
BIS MHD 7 published-standard work programme
The named medical-device QMS national publication and the adoption identity recorded by BIS.
Source checked 2026-10-20
India · Standards relationship
IS/ISO/IEC 17025:2017 preserves the international laboratory-competence identity
BIS national adoption identity for laboratory competence
The named Indian laboratory-competence publication and its international-source identity.
Source checked 2026-10-20
India · Standards relationship
The toy QCO selects named IS 9873 parts rather than a generic international toy certificate
Toys (Quality Control) Order 2020: selected Indian standards
Toy categories and hazards covered by the corresponding QCO table entries.
Source checked 2026-10-20
India · Standards relationship
Indian ICT registration migrates to IS/IEC 62368 Part 1 with different concurrency dates
Migration to IS/IEC 62368 Part 1:2023 under the Electronics and IT Goods Registration Order
Goods affected by the specific substitutions in the 2021 compulsory-registration order, including its added extended-reality category.
Source checked 2026-10-20
South Korea · Requirement analysis
Safety-certification products require model-specific certification
Electrical Appliances and Consumer Products Safety Control Act · Article 5(1), with Article 5(3)
Manufacturers, including foreign manufacturers exporting to Korea, or importers of products designated for safety certification.
Source checked 2026-10-20
South Korea · Requirement analysis
Safety verification combines testing with a model-specific report to the authority
Electrical Appliances and Consumer Products Safety Control Act · Article 15(1), with Article 15(4)-(5)
Manufacturers or importers of products designated for safety verification.
Source checked 2026-10-20
South Korea · Requirement analysis
Supplier self-declaration still requires retained proof of safety conformity
Electrical Appliances and Consumer Products Safety Control Act · Article 23(5), read with Article 23(1)-(2)
Manufacturers or importers conducting supplier conformity confirmation for designated products.
Source checked 2026-10-20
South Korea · Requirement analysis
Radio-equipment conformity uses the route actually assigned by the current Radio Waves Act
Radio Waves Act · Article 58-2(1)
Persons intending to manufacture, sell or import the broadcasting/communications and electromagnetic-compatibility equipment covered by the provision.
Source checked 2026-10-20
South Korea · Requirement analysis
Required device facilities and the manufacturing-quality system precede the application
Medical Devices Act · Article 6(4)
Applicants for manufacturing-business permission and applicants/filers for the relevant device manufacture permission, certification or notification.
Source checked 2026-10-20
South Korea · Requirement analysis
Food with missing or improperly presented mandatory information cannot enter the specified supply activities
Act on Labeling and Advertising of Foods · Article 4(3), with Article 4(1)-(2)
Food and other covered articles lacking the required information or breaching the prescribed labelling method.
Source checked 2026-10-20
South Korea · Standards relationship
The Korean sterility-testing publication has an explicit edition-specific ISO adoption record
Korean standard catalogue: sterilisation microbiological methods, Part 2
The specific KS catalogue record and its stated international adoption relationship.
Source checked 2026-10-20
South Korea · Standards relationship
KC 60335-1 is an issued electrical-safety criterion, distinct from a KS catalogue identity
KATS household electrical-appliance safety criterion notice
Covered household and similar electrical appliances using the relevant statutory product-safety route and criterion.
Source checked 2026-10-20
South Korea · Standards relationship
KOLAS testing-laboratory recognition uses KS Q ISO/IEC 17025 and a defined scope
KOLAS official testing-laboratory register and criteria
KOLAS testing laboratories and the activities appearing in their individual recognised scopes.
Source checked 2026-10-20
South Korea · Standards relationship
The portable lithium-cell safety criterion must be distinguished from its 2026 amendment proposal
KATS portable sealed lithium secondary-cell safety criterion
Portable sealed lithium secondary cells/batteries within the applicable product-safety classification and criterion.
Source checked 2026-10-20
Singapore · Requirement analysis
The importer or manufacturer must register both the supplier and the Controlled Goods
Consumer Protection (Safety Requirements) Regulations · Regulation 5(1)
Importers or manufacturers in Singapore intending, in trade or business, to supply or advertise for supply Controlled Goods.
Source checked 2026-10-20
Singapore · Requirement analysis
Only the lawful registered-product route supports use of the SAFETY Mark
Consumer Protection (Safety Requirements) Regulations · Regulations 13(1)-(3) and 14(1)
Affixing the SAFETY Mark to registered Controlled Goods.
Source checked 2026-10-20
Singapore · Requirement analysis
General consumer goods use category-specific safety requirements rather than Controlled Goods registration
Consumer Protection (Consumer Goods Safety Requirements) Regulations 2011 · Regulation 4, read with regulation 3 and the Schedule
Consumer goods within the Regulations and their Category 1 or Category 2 classification.
Source checked 2026-10-20
Singapore · Requirement analysis
A dealer's licence does not replace equipment approval for sale
Telecommunications (Dealers) Regulations · Regulation 20(1), subject to paragraph (2) and regulation 4(7)
A licensee selling the telecommunications or radio-communication equipment described in regulation 20(1).
Source checked 2026-10-20
Singapore · Requirement analysis
Medical-device supply records must identify each supply and remain available for inspection
Health Products (Medical Devices) Regulations 2010 · Regulation 39(1) and (1A)
The manufacturers, importers, wholesalers, registrants and other suppliers identified by regulation 39(1).
Source checked 2026-10-20
Singapore · Requirement analysis
Prepacked food must carry the prescribed particulars before import or distribution
Food Regulations · Regulation 5(1), subject to regulation 6
Prepacked food imported, advertised, manufactured, sold, consigned or delivered within regulation 5.
Source checked 2026-10-20
Singapore · Standards relationship
Rice-cooker registration uses a specified minimum IEC liquid-heating appliance edition
CPSO minimum safety-standard list for Controlled Goods
Rice cookers within the regulator's household-appliance definition.
Source checked 2026-10-20
Singapore · Standards relationship
The audio/video Controlled Goods entry permits defined IEC 62368-1 or IEC 60065 references
CPSO minimum safety-standard list for Controlled Goods
Mains-fed home-entertainment audio/video products within the regulator's defined entry.
Source checked 2026-10-20
Singapore · Standards relationship
SAC-SINGLAS testing and calibration criteria use ISO/IEC 17025:2017
Singapore Accreditation Council laboratory accreditation criteria
Testing and calibration laboratory accreditation under SAC-SINGLAS.
Source checked 2026-10-20
Singapore · Standards relationship
SAC medical-testing accreditation uses ISO 15189:2022 rather than the general laboratory branch
Singapore Accreditation Council medical-laboratory criteria
Medical-testing laboratories within SAC's medical-testing accreditation scope.
Source checked 2026-10-20
Brazil · Requirement analysis
Safety information for industrial consumer products
Consumer Protection Code · Article 8, paragraph 1
Suppliers placing consumer goods in Brazil; paragraph 1 concerns industrial products.
Source checked 2026-10-20
Brazil · Requirement analysis
Mandatory certification of covered household appliances
Inmetro Ordinance 148/2022 · Article 5 and paragraphs 1–4
Appliances and similar equipment within the ordinance scope, made or supplied in Brazil.
Source checked 2026-10-20
Brazil · Requirement analysis
Toy age classification and the basis for testing
Inmetro Ordinance 302/2021 · Annex B, paragraphs 1–3
Toys covered by the Brazilian toy regulation.
Source checked 2026-10-20
Brazil · Requirement analysis
Homologation before use or sale of telecommunications products
Anatel Resolution 715/2019 · Annex, Article 55, including the 2025 amendments
Telecommunications products within the regulation, including relevant online sales.
Source checked 2026-10-20
Brazil · Requirement analysis
Lot or serial identification on medical-device labels
Anvisa RDC 751/2022 · Article 47(V)
Medical devices subject to the labelling provisions of RDC 751/2022.
Source checked 2026-10-20
Brazil · Requirement analysis
Portuguese and legibility of mandatory packaged-food information
Anvisa RDC 727/2022 · Article 8 andsole paragraph
Mandatory information on packaged foods within RDC 727/2022.
Source checked 2026-10-20
Brazil · Standards relationship
IEC 60335 references in the appliance certification framework
Inmetro Ordinance 148/2022 reference list · Referenced technical documents; Annex I reference framework
Selection of the general and relevant particular appliance standards under the ordinance.
Source checked 2026-10-20
Brazil · Standards relationship
ABNT NBR NM 300 references in toy regulation
Inmetro Ordinance 302/2021 toy reference framework · Technical-reference list
Covered toys and relevant mechanical, fire or chemical assessment.
Source checked 2026-10-20
Brazil · Standards relationship
Cgcre laboratory accreditation uses ABNT NBR ISO/IEC 17025:2017
Cgcre accredited laboratory programme · Testing and calibration laboratory categories
Checking competence for a particular test or calibration.
Source checked 2026-10-20
Brazil · Standards relationship
Product-certification body accreditation uses ABNT NBR ISO/IEC 17065
Cgcre product-certification body accreditation · Service description: product certification bodies
Review of a product-certification body and its authorised scope.
Source checked 2026-10-20
Mexico · Requirement analysis
Essential safety markings on electrical products
NOM-003-SCFI-2014 Electrical products—Safety specifications · Clause 5.1
Electrical products in Clause 2, subject to its product-specific exclusions.
Source checked 2026-10-20
Mexico · Requirement analysis
Spanish and accessible commercial information
NOM-050-SCFI-2004 General product labelling · Clause 5.2.2
Products covered by general commercial-labelling NOM 050.
Source checked 2026-10-20
Mexico · Requirement analysis
Manufacturer-recommended age on toy packaging
NOM-015-SCFI-2007 Toy labelling · Clause 5.1.2(f), read with 5.1.3
Toys within the commercial-information rule.
Source checked 2026-10-20
Mexico · Requirement analysis
Documented quality system for medical-device establishments
NOM-241-SSA1-2025 Good manufacturing practices for medical devices · Clause 5.1.2
Establishments within the scope of the medical-device GMP rule.
Source checked 2026-10-20
Mexico · Requirement analysis
Safety data sheets for workplace hazardous chemicals
NOM-018-STPS-2015 Hazard communication in workplaces · Clauses 6.3–6.4 and Chapter 9
Employers handling hazardous chemicals or mixtures within the NOM scope.
Source checked 2026-10-20
Mexico · Requirement analysis
Ingredient-list heading and quantitative order
NOM-051-SCFI/SSA1-2010 as amended in 2020 · Clauses 4.2.2.1.1–4.2.2.1.2
Individually marketed prepackaged foods and non-alcoholic beverages within the rule.
Source checked 2026-10-20
Mexico · Standards relationship
NOM-003-SCFI-2014 makes national appliance safety references operative
NOM-003-SCFI-2014 andNMX-J-521/1-ANCE · Clause 3 andthe applicable appliance section
Household and similar appliances falling within the relevant NOM-003 section.
Source checked 2026-10-20
Mexico · Standards relationship
Mexican adoption of ISO/IEC 17025:2017
NMX-EC-17025-IMNC-2018 · International concordance statement
Laboratory competence standard selection and national publication identification.
Source checked 2026-10-20
Mexico · Standards relationship
NOM-001-SCFI-2018 references the national IT equipment safety standard
NOM-001-SCFI-2018 normative references · Normative reference list: NMX-I-60950-1-NYCE-2015
Relevant electronic equipment and product functions within NOM-001.
Source checked 2026-10-20
Mexico · Standards relationship
Mexico adapts GHS rather than adopting every later UN revision
NOM-018-STPS-2015 international concordance · International concordance and Chapter 9
Hazard communication for hazardous workplace chemicals.
Source checked 2026-10-20
Saudi Arabia · Requirement analysis
Protective devices against ejected material and machinery emissions
Technical Regulation for Machinery Safety, Part 1 · Article 4/1/2
Portable and hand-oriented machinery, relevant safety components and interchangeable equipment within Article 2.
Source checked 2026-10-20
Saudi Arabia · Requirement analysis
Technical file for restricted-substance conformity
Technical Regulation for Restriction of Hazardous Substances in Electrical and Electronic Equipment · Article 4/1/2
Imported electrical/electronic equipment in the specified scope.
Source checked 2026-10-20
Saudi Arabia · Requirement analysis
Fire-safety objectives for insulation and cladding materials
Technical Regulation for Building Materials, Part 2: Insulation and Building Cladding Materials · Article 4/1/1
Insulation and cladding materials included in the regulation.
Source checked 2026-10-20
Saudi Arabia · Requirement analysis
Safety data information accompanying adhesive products
Technical Regulation for Glue and Adhesive Materials · Article 4/1/7
Adhesive products falling within the technical regulation.
Source checked 2026-10-20
Saudi Arabia · Requirement analysis
Manufacturer technical documentation for low-voltage equipment
Gulf Technical Regulation BD-142004-01 · Article 8(3)–(5), read with Annexes 3–4
Manufacturers of electrical equipment within the Gulf regulation as applicable in Saudi Arabia.
Source checked 2026-10-20
Saudi Arabia · Requirement analysis
Supply-chain identification for low-voltage equipment
Gulf Technical Regulation BD-142004-01 · Article 13(1)–(2)
Economic operators supplying covered low-voltage equipment in Saudi Arabia.
Source checked 2026-10-20
Saudi Arabia · Standards relationship
ISO 9001 certificate as a specified quality-system route under Saudi RoHS
Saudi restricted-substances regulation, version 2 · Article 4/1/3
Manufacturing quality-system evidence for products within the restricted-substances regulation.
Source checked 2026-10-20
Saudi Arabia · Standards relationship
SASO IEC 63000 supports restricted-substance technical documentation
Saudi restricted-substances regulation reference list · Annex 2-a, item 1
Technical-documentation selection for restricted-substance assessment.
Source checked 2026-10-20
Saudi Arabia · Standards relationship
IEC 60335 family in a current Gulf notified-body scope
GSO notification schedule for BD-142004-01 · NB0051 schedule, household and similar electrical appliances
Selection of a notified body for a covered appliance conformity assessment.
Source checked 2026-10-20
Saudi Arabia · Standards relationship
SAAC product-certification accreditation uses ISO/IEC 17065
SAAC certification-body accreditation programme · Certification Bodies service: product/process/service certification
Review of certification-body competence and accredited scope.
Source checked 2026-10-20
United Arab Emirates · Requirement analysis
Continued safety and remedial action after market entry
Federal Law 10 of 2018 on Product Safety · Article 6(1)–(3)
Suppliers of products within the product-safety law.
Source checked 2026-10-20
United Arab Emirates · Requirement analysis
Scientific basis and contents of product risk-assessment reports
Cabinet Resolution 38 of 2021: Product Safety Executive Regulations · Article 5
The product risk-assessment report required under the law and executive rules.
Source checked 2026-10-20
United Arab Emirates · Requirement analysis
Restricted substances are assessed in homogeneous materials
Cabinet Resolution 10 of 2017: Hazardous Substance Ratios in Electric and Electronic Devices · Article 3(1)–(2), read with Article 2
Products in Annex 1, including covered repair/reuse/update parts.
Source checked 2026-10-20
United Arab Emirates · Requirement analysis
Textile supplier checks for safety and consumer labels
Cabinet Resolution 54 of 2019: UAE Scheme for Control of Textile Products · Article 3(2), read with Article 2
Covered clothing, fabrics, indoor textiles and products meeting the stated textile-composition criterion.
Source checked 2026-10-20
United Arab Emirates · Requirement analysis
Marketing approval before circulation of medical products
Federal Decree-Law 38 of 2024 Governing Medical Products, Pharmacists and Pharmaceutical Establishments · Article 5(1)–(3)
Medical Products as defined by the decree-law, intended for circulation in the UAE.
Source checked 2026-10-20
United Arab Emirates · Requirement analysis
Energy-efficiency classification of non-domestic lighting products
Cabinet Resolution of 2022 Regarding the Regulation of Outdoor Lighting Products · Article 4, read with Article 2 and Annex 2
Non-domestic lighting products and standalone control gear within Article 2.
Source checked 2026-10-20
United Arab Emirates · Standards relationship
ENAS testing and calibration accreditation uses ISO/IEC 17025
Emirates National Accreditation System laboratory programme · Accreditation programmes: testing and calibration
Checking competence for a specified laboratory activity.
Source checked 2026-10-20
United Arab Emirates · Standards relationship
ENAS product-certification accreditation uses ISO/IEC 17065
Emirates National Accreditation System product-certification programme · Product-certification accreditation scheme
Competence and scope of a product/process/service certification body.
Source checked 2026-10-20
United Arab Emirates · Standards relationship
UAE lighting annex specifies IEC 60969-based measurements
Annex to the UAE 2022 outdoor-lighting regulation · Annex: directional compact fluorescent lamps, measured-parameter table
The specified measurements for directional compact fluorescent lamps.
Source checked 2026-10-20
United Arab Emirates · Standards relationship
Electrical clinical thermometer rules use ISO 80601-2-56:2017
Cabinet Resolution No. 90 of 2023 concerning obligatory requirements for medical and laboratory measuring devices · Attachment 2, sections 2.2 and 3.2(1)
Electrical medical clinical thermometers within Attachment 2 of the Resolution.
Source checked 2026-10-20
Türkiye · Requirement analysis
Manufacturer technical file and retention duties
Product Safety and Technical Regulations Law No. 7223 · Article 7(1)(b) and (c)
Manufacturers placing products on the Turkish market, subject to the applicable technical regulation and the Law’s scope.
Source checked 2026-10-20
Türkiye · Requirement analysis
Importer checks before placing a product on the market
Product Safety and Technical Regulations Law No. 7223 · Article 9(1)(b)
Importers placing products covered by the Law on the Turkish market.
Source checked 2026-10-20
Türkiye · Requirement analysis
Supply chain traceability records
Product Safety and Technical Regulations Law No. 7223 · Article 12(1) and (2)
Economic operators, including the online and intermediary activities described in Article 12(2).
Source checked 2026-10-20
Türkiye · Requirement analysis
Recall notices and remedies for end users
Product Safety and Technical Regulations Law No. 7223 · Article 19(1)–(3)
Economic operators where other measures are insufficient to eliminate the product risk.
Source checked 2026-10-20
Türkiye · Requirement analysis
Notification when a consumer product presents a safety risk
General Product Safety Regulation · Article 9(1) and (2)
Producers and distributors of products within the General Product Safety Regulation’s scope.
Source checked 2026-10-20
Türkiye · Requirement analysis
Declaration language and combined regulatory coverage
CE Marking Regulation · Article 11(2) and (3)
Products subject to Turkish technical regulations that require an EU declaration of conformity and CE marking.
Source checked 2026-10-20
Türkiye · Standards relationship
Turkish publication of the ISO 9001 quality management standard
TS EN ISO 9001:2015 · National publication and TSE management system certification programme
Organizations researching the Turkish national designation and the TSE quality management certification route.
Source checked 2026-10-20
Türkiye · Standards relationship
TSE medical device quality management certification to ISO 13485
TSE medical device quality management system certification · 2024 activity report: system certification and accreditation scope tables
Organizations evaluating the TSE medical device quality management system certification programme.
Source checked 2026-10-20
Türkiye · Standards relationship
TÜRKAK laboratory accreditation uses ISO/IEC 17025
TÜRKAK testing and calibration laboratory accreditation · Laboratory accreditation basis and EA MLA testing/calibration scopes
Testing and calibration laboratories seeking TÜRKAK accreditation and users assessing laboratory competence.
Source checked 2026-10-20
Türkiye · Standards relationship
TÜRKAK transition to ISO 15189:2022 for medical laboratories
TÜRKAK ISO 15189:2022 transition policy · Published ISO 15189 transition announcement and medical laboratory programme
Medical laboratories and organizations selecting accredited medical laboratory services.
Source checked 2026-10-20
South Africa · Requirement analysis
Consumer goods must meet the statutory quality and safety rights
Consumer Protection Act 68 of 2008 · Section 55(1)–(4)
Consumer transactions within the Act’s application, including goods supplied for an identified particular purpose under section 55(3).
Source checked 2026-10-20
South Africa · Requirement analysis
Communications equipment requires type approval unless exempt
ICASA Type Approval Regulations, 2013 · Regulation 3(1)
Equipment used or intended for use in connection with the provision of electronic communications.
Source checked 2026-10-20
South Africa · Requirement analysis
Type approval supplier registration and change reporting
ICASA Type Approval Regulations, 2013 · Regulation 4(1)–(3)
Applicants for ICASA equipment type approval.
Source checked 2026-10-20
South Africa · Requirement analysis
LED luminaires under VC 8055 use specified safety requirements
Amendment to the Compulsory Specification for Electrical and Electronic Apparatus (VC 8055) · Requirement 3.6(e), inserted by Government Notice 835 of 2014
Luminaires using LEDs as a light source within the compulsory specification’s scope.
Source checked 2026-10-20
South Africa · Requirement analysis
Declare the constituents of compound food ingredients
Regulations relating to the Labelling and Advertising of Foodstuffs, R.146 of 2010 · Regulation 27, subject to Regulations 42–46
Foodstuffs using a compound ingredient, including the example of milk solids stated in the Regulation.
Source checked 2026-10-20
South Africa · Requirement analysis
Prepare and maintain hazardous chemical safety data sheets
Regulations for Hazardous Chemical Agents, 2021 · Regulation 14A(1)(a) and (b), read with Regulation 14
Manufacturers and importers of hazardous chemical agents supplied to workplaces, within the Regulations’ scope.
Source checked 2026-10-20
South Africa · Standards relationship
NRCS appliance approval guidance identifies SANS IEC 60335
NRCS Letter of Authority process for electrical and electronic apparatus · ET/SCF018, Issue 12, section 1.1(a)
Household and similar appliances within the scope of the relevant compulsory specification and approval process.
Source checked 2026-10-20
South Africa · Standards relationship
SANAS laboratory accreditation to ISO/IEC 17025
SANAS testing and calibration laboratory accreditation · Published accreditation certificate and AFRAC arrangement testing/calibration scopes
Laboratories and purchasers evaluating competence for defined testing or calibration activities.
Source checked 2026-10-20
South Africa · Standards relationship
SANAS product certification recognition uses ISO/IEC 17065
SANAS product certification accreditation and AFRAC recognition · AFRAC arrangement membership list, South Africa product certification scope
Bodies and purchasers evaluating accredited product certification within the specific programme and scope.
Source checked 2026-10-20
South Africa · Standards relationship
SANAS medical device system certification criteria link ISO 13485 and ISO/IEC 17021-1
Criteria for Certification Body Accreditation in the Scope of Medical Device Quality Management Systems · TR 91-02, sections 1 and 2
Certification bodies seeking SANAS accreditation to audit and certify medical device quality management systems.
Source checked 2026-10-20
Indonesia · Requirement analysis
Do not market goods that fail required standards
Law No. 8 of 1999 on Consumer Protection · Article 8(1)(a) and (4)
Businesses producing or trading consumer goods or services within the Law’s scope.
Source checked 2026-10-20
Indonesia · Requirement analysis
Provide required product information and instructions in Indonesian
Law No. 8 of 1999 on Consumer Protection · Article 8(1)(j)
Businesses supplying goods for which information or instructions are required by the applicable legislation.
Source checked 2026-10-20
Indonesia · Requirement analysis
Certification when an SNI has been made compulsory
Law No. 20 of 2014 on Standardization and Conformity Assessment · Article 25(1)–(4), read with Article 24
Businesses and the other named actors subject to a ministerial or agency regulation making a particular SNI compulsory.
Source checked 2026-10-20
Indonesia · Requirement analysis
Telecommunications testing and certificate coverage
Minister of Communication and Informatics Regulation No. 3 of 2024 on Telecommunications Equipment Certification · Articles 6 and 7
Telecommunications equipment and other devices with telecommunications features within the Regulation’s scope, subject to the applicable exceptions.
Source checked 2026-10-20
Indonesia · Requirement analysis
Distinguish certificate validity from the production and import window
Minister of Communication and Informatics Regulation No. 3 of 2024 on Telecommunications Equipment Certification · Article 18(1)–(3)
Holders of certificates issued under Article 15 that manufacture, assemble or import the covered equipment for trade or use in Indonesia.
Source checked 2026-10-20
Indonesia · Requirement analysis
Bottled water storage wording and polycarbonate packaging warning
BPOM Regulation No. 6 of 2024 amending the processed food labelling regulation · Article I inserting Articles 48A and 61A; Article II transition
Bottled drinking water; the BPA warning specifically concerns bottled water using polycarbonate plastic packaging.
Source checked 2026-10-20
Indonesia · Standards relationship
SNI ISO 9001:2015 is an identical national adoption
SNI ISO 9001:2015 — Quality management systems — Requirements · Official catalogue: equivalence and status fields
Organizations identifying an Indonesian quality management system standard.
Source checked 2026-10-20
Indonesia · Standards relationship
SNI ISO/IEC 17025:2017 adopts the international laboratory competence standard
SNI ISO/IEC 17025:2017 — General requirements for the competence of testing and calibration laboratories · Official catalogue: designation, identical adoption and establishment decision
Laboratories and purchasers identifying the Indonesian national laboratory competence standard.
Source checked 2026-10-20
Indonesia · Standards relationship
SNI ISO 13485:2016 adopts the medical device quality management standard
SNI ISO 13485:2016 — Medical devices — Quality management systems — Requirements for regulatory purposes · Official catalogue: equivalence and establishment fields
Organizations working within the medical device lifecycle and suppliers specifying a national quality management reference.
Source checked 2026-10-20
Indonesia · Standards relationship
SNI IEC 62368-1:2014 adopts the identified IEC safety edition and corrigendum
SNI IEC 62368-1:2014 — Audio/video, information and communication technology equipment — Part 1: Safety requirements · Official catalogue: IEC equivalence and active status
Organizations identifying a national safety reference for audio/video and information and communication technology equipment.
Source checked 2026-10-20
Vietnam · Requirement analysis
Match conformity assessment to the current product risk category
Law on Product and Goods Quality, as amended by Law No. 78/2025/QH15 · Article 5(2)–(5), consolidated in 156/VBHN-VPQH
Products and goods within the Law’s scope; the applicable list and sector rules determine the actual risk category and management route.
Source checked 2026-10-20
Vietnam · Requirement analysis
Traceability obligations depend on the high risk product rollout
Law on Product and Goods Quality, as amended by Law No. 78/2025/QH15 · Article 6d(1)–(3)
Traceability and supply chain transparency under the quality law; compulsory traceability for high risk products follows the competent ministry’s determination and roadmap.
Source checked 2026-10-20
Vietnam · Requirement analysis
Production controls and quality records before market circulation
Law on Product and Goods Quality, as amended by Law No. 78/2025/QH15 · Article 28(1)(a)–(d) and (đ); Article 28(2)
Manufacturers preparing products for market circulation, with the separate provisions for small scale production considered.
Source checked 2026-10-20
Vietnam · Requirement analysis
Product information and complaint controls on digital marketplaces
Law on Product and Goods Quality, as amended by Law No. 78/2025/QH15 · Article 34b(2) and (3)
Sellers and intermediary platform operators involved in goods traded through digital platforms for electronic transactions.
Source checked 2026-10-20
Vietnam · Requirement analysis
Accurate consumer information, instructions and replacement part availability
Law No. 19/2023/QH15 on Protection of Consumers’ Rights · Article 21(1), (2), (4) and (5)
Businesses providing products, goods or services to consumers within the Law’s scope.
Source checked 2026-10-20
Vietnam · Requirement analysis
Defective product recall and authority reporting
Law No. 19/2023/QH15 on Protection of Consumers’ Rights · Article 32(1) and Article 33(1)–(4)
Businesses discovering defective products or goods within the consumer protection law.
Source checked 2026-10-20
Vietnam · Standards relationship
TCVN ISO 9001:2015 is an identical adoption of ISO 9001:2015
TCVN ISO 9001:2015 — Quality management systems — Requirements · Official catalogue equivalence, status and publication decision
Organizations selecting a Vietnamese national quality management system reference.
Source checked 2026-10-20
Vietnam · Standards relationship
TCVN ISO IEC 17025:2017 adopts the international laboratory competence standard
TCVN ISO IEC 17025:2017 — General requirements for the competence of testing and calibration laboratories · Official catalogue equivalence and publication announcement
Laboratories and users identifying the Vietnamese national laboratory competence document.
Source checked 2026-10-20
Vietnam · Standards relationship
TCVN ISO 13485:2017 adopts ISO 13485:2016
TCVN ISO 13485:2017 — Medical devices — Quality management systems — Requirements for regulatory purposes · Official catalogue equivalence and replaced documents
Organizations working with medical device quality management systems and suppliers comparing national and international document identities.
Source checked 2026-10-20
Vietnam · Standards relationship
TCVN 5699-1:2010 adopts the identified IEC appliance safety edition
TCVN 5699-1:2010 — Household and similar electrical appliances — Safety — Part 1: General requirements · Official catalogue equivalence and revision history
Household and similar electrical appliances within the standard’s scope.
Source checked 2026-10-20
No records match these filters
Change a subject or market, or clear the filters to return to the collection.
Read the conditions with the requirement
Select a record to examine its product and role, source location, required action and evidence. Materials suggested for a research review are distinguished from documents expressly required by the source. Follow the official source before applying a conclusion to an actual product or transaction.