Research on defined product requirements and the use of standards in China. Each record identifies its scope, source and practical evidence questions.
Market scope
GB/GB-T, mandatory/recommended, CCC and national adoption are distinct.
The records below examine specific provisions and standards relationships. They do not combine different products or regulatory roles into one approval route.
Mandatory standards as a production and market-entry boundary
Standardization Law of the People's Republic of China · Article 25, read with Article 2
Article 25 prohibits production, sale, import or provision of products and services that do not meet mandatory standards. Article 2 distinguishes mandatory national standards from recommended standards. The decision therefore starts with the product or service and the applicable mandatory document, rather than with a supplier's general management-system certificate. An international designation alone does not determine the Chinese mandatory requirement.
Scope, actions and official sources
Issuer
National People's Congress Standing Committee
Status and context
Current official source checked; selected scope only
Edition or text examined
2017 revision; current SAMR legal text
Legal character
Binding within the stated scope
Source check
2026-10-20
Applies to
Products or services subject to an applicable Chinese mandatory standard.
Scope and conditions
Recommended GB/T standards do not become mandatory merely because they are national standards.,A product-specific law may establish additional duties.
Actions
Identify the product and the mandatory standard actually covering it.
Resolve the operative edition and any implementation transition before release.
Prevent production, sale, import or service provision when the applicable mandatory requirements are unmet.
Materials for the research review
Product-scope decision and operative-standard register.
Test or other conformity evidence addressing the applicable mandatory requirements.
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
For products within its scope, Article 2 makes the applicable compulsory conformity procedure and certification marking a condition of factory release, sale, import and use in other business activities. Catalogue classification is a substantive step: a broad description such as electronic equipment does not settle coverage. Certification results, model identity and the approved route must correspond to the goods actually released.
Scope, actions and official sources
Issuer
State Administration for Market Regulation
Status and context
Current official source checked; selected scope only
Edition or text examined
2009 provisions as amended 2022-09-29
Legal character
Binding within the stated scope
Source check
2026-10-20
Applies to
Products actually included in the compulsory certification catalogue and within the relevant implementation rule.
Scope and conditions
Products outside the catalogue are not made CCC products by this article.,The applicable certification or officially permitted declaration route and the specific exemptions must be established separately.
Actions
Check the current catalogue description and product-scope boundary.
Complete the applicable procedure before the specified commercial activity.
Control the correspondence between covered models, valid conformity documentation and the mark.
Evidence identified by the source
Applicable compulsory conformity result and mark for covered products.
Materials for the research review
Catalogue decision and implementation-rule reference.
Model, manufacturer and shipment comparison against the relevant certificate or authorised declaration.
Device production must follow the operating QMS and product technical requirements
Regulations for the Supervision and Administration of Medical Devices · Article 35
Article 35 requires the relevant device businesses to establish an appropriate quality management system under the medical-device manufacturing requirements and keep it operating effectively. Production must follow the registered or filed product technical requirements, and released devices must meet those requirements and applicable mandatory standards. The same article requires regular self-inspection of the QMS and submission of the self-inspection report in accordance with the national drug regulator's provisions.
Scope, actions and official sources
Issuer
State Council of the People's Republic of China
Status and context
Current official source checked; selected scope only
Edition or text examined
Current SAMR legal text of the 2021 regulation
Legal character
Binding within the stated scope
Source check
2026-10-20
Applies to
Medical-device registrants, filing holders and entrusted manufacturing enterprises within Article 35.
Scope and conditions
A management-system certificate does not replace registered or filed product technical requirements.,Product classification, licensing and other manufacturing provisions remain separate.
Actions
Maintain an operating QMS appropriate to the devices manufactured.
Manufacture and release against the registered or filed technical requirements and mandatory standards.
Conduct the required regular QMS self-inspection and submit its report.
Evidence identified by the source
Regular QMS self-inspection report required by Article 35.
Materials for the research review
Approved product technical requirements and their controlled production version.
Evidence linking actual production and release decisions to those requirements.
Prepackaged food must carry the legally required label particulars
Food Safety Law of the People's Republic of China · Article 67
Article 67 requires a label on prepackaged food and identifies the principal information categories: product identity and quantity, ingredients, producer information, shelf life, product-standard identification, storage conditions, additive names and other required particulars. Its final paragraph preserves the applicable food-safety standard where that standard provides differently. A digital presentation should therefore be assessed against the operative physical-label requirements and any specific digital-label rule, rather than assumed to replace the package label.
Scope, actions and official sources
Issuer
National People's Congress Standing Committee
Status and context
Current official source checked; selected scope only
Edition or text examined
Text incorporating the 2025-09-12 amendment
Legal character
Binding within the stated scope
Source check
2026-10-20
Applies to
Prepackaged food supplied within the Food Safety Law and the applicable food-safety standards.
Scope and conditions
Article 67 preserves different labelling particulars specified by national food-safety standards.,Foods for infants and other specific populations have additional nutritional particulars.,Imported food labelling and specialised categories require their separate provisions.
Actions
Classify the food and applicable labelling standard.
Check each required category against the final package artwork.
Reconcile category-specific and imported-food requirements before distribution.
Evidence identified by the source
A package label containing the particulars required by Article 67 and the applicable standard.
Materials for the research review
Final artwork, ingredient specification and quantity/date/storage data.
Documented treatment of any standard-specific labelling exception.
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
Article 13 requires producers and importers to identify hazardous substances in their in-scope products according to the relevant national or industry marking standard. The information addresses substances, content, affected parts and specified recycling or disposal implications. If size, shape, surface material or function prevents marking on the product, the provision permits the information in the product instructions. The information duty should not be confused with proof that a product is outside the separate compliance catalogue.
Scope, actions and official sources
Issuer
Ministry of Industry and Information Technology and the other issuing departments
Status and context
Current official source checked; selected scope only
Edition or text examined
2016 measures; official MIIT text
Legal character
Binding within the stated scope
Source check
2026-10-20
Applies to
Producers and importers placing electrical and electronic products within the defined scope on the Chinese market.
Scope and conditions
Article 3 excludes equipment involved in electricity generation, transmission and distribution from its product definition.,Information marking is distinct from the separate catalogue-based substance-limit conformity procedure.
Actions
Determine whether the product falls within Articles 2-3.
Prepare substance information using the applicable marking rules.
Place the information on the product or, where Article 13 permits, in its instructions.
Evidence identified by the source
Hazardous-substance information marking or the permitted instruction-based information.
Materials for the research review
Material and supplier information supporting the disclosed substance/part data.
Recorded reason for using instructions instead of on-product marking.
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
Article 17 establishes three reporting routes. A voluntary recall plan is reported to the producer's provincial market-regulation authority within ten working days after the defect conclusion. For a recall initiated following notification, the clock runs from receipt and the report goes to the notifying authority. An ordered recall is reported to SAMR within ten working days after the order. Article 18 specifies the plan's substantive contents, including affected scope, remedial measures and implementation arrangements.
Scope, actions and official sources
Issuer
State Administration for Market Regulation
Status and context
Current official source checked; selected scope only
Edition or text examined
2019 provisions; current SAMR legal text
Legal character
Binding within the stated scope
Source check
2026-10-20
Applies to
Producers conducting a consumer-product recall under these provisions; Article 29 also addresses imported goods.
Scope and conditions
A separate recall authority or procedure established by other laws or rules takes precedence under Article 2.,The filing destination and starting event differ between voluntary, notified and ordered recalls.
Actions
Identify the recall route and the event starting its reporting period.
Prepare the plan contents required by Article 18.
Report to the correct authority within the applicable ten-working-day period.
Evidence identified by the source
Recall plan reported under Article 17 and containing Article 18 particulars.
Materials for the research review
Defect conclusion, notification or order showing the clock start.
Submission acknowledgment and affected-model or batch rationale.
These records distinguish adoption, legal incorporation, designation and programme recognition. A standard’s use is assessed within the specific relationship recorded.
Standards relationship · CN-R01
Medical-device QMS: the national adoption is ISO 13485:2016
Official national-standard catalogue record for GB/T 42061-2022
The SAMR catalogue identifies GB/T 42061-2022 as a identical adoption of ISO 13485:2016. The relationship belongs to those stated editions. The catalogue identifies this GB/T document as recommended. Adoption identity by itself does not make certification or product approval compulsory. A later international revision does not silently replace the source edition recorded for the Chinese publication.
Scope, actions and official sources
Issuer
SAMR / Standardization Administration of China
Status and context
Current official source checked; selected scope only
Edition or text examined
GB/T 42061-2022 / ISO 13485:2016
Relationship
National adoption
Legal character
Voluntary reference
Source check
2026-10-20
Applies to
The named Chinese publication and its officially recorded international-source relationship.
Scope and conditions
No protected technical clauses or test limits are reproduced.,This relationship does not establish NCQM accreditation, certification or regulatory acceptance.
Actions
Identify both national and international designations in the evidence record.
Use the stated adoption degree; examine national differences where the record is MOD.
Check separately which law, procurement specification or assessment programme selects the document.
Materials for the research review
Catalogue identity and adoption-degree record.
The edition and scope appearing on the actual certificate, report or specification.
Medical electrical safety: a modified IEC 60601-1 adoption
Official national-standard catalogue record for GB 9706.1-2020
The SAMR catalogue identifies GB 9706.1-2020 as a modified adoption of IEC 60601-1:2012. The relationship belongs to those stated editions. The GB designation is mandatory; product applicability, special standards and implementation arrangements still have to be resolved for the particular medical electrical equipment. A later international revision does not silently replace the source edition recorded for the Chinese publication.
Scope, actions and official sources
Issuer
SAMR / Standardization Administration of China
Status and context
Current official source checked; selected scope only
Edition or text examined
GB 9706.1-2020 / IEC 60601-1:2012
Relationship
National adoption
Legal character
Binding within the stated scope
Source check
2026-10-20
Applies to
The named Chinese publication and its officially recorded international-source relationship.
Scope and conditions
No protected technical clauses or test limits are reproduced.,This relationship does not establish NCQM accreditation, certification or regulatory acceptance.
Actions
Identify both national and international designations in the evidence record.
Use the stated adoption degree; examine national differences where the record is MOD.
Check separately which law, procurement specification or assessment programme selects the document.
Materials for the research review
Catalogue identity and adoption-degree record.
The edition and scope appearing on the actual certificate, report or specification.
Laboratory competence: the Chinese adoption of ISO/IEC 17025
Official national-standard catalogue record for GB/T 27025-2019
The SAMR catalogue identifies GB/T 27025-2019 as a identical adoption of ISO/IEC 17025:2017. The relationship belongs to those stated editions. The catalogue identifies this GB/T document as recommended. Adoption identity by itself does not make certification or product approval compulsory. A later international revision does not silently replace the source edition recorded for the Chinese publication.
Scope, actions and official sources
Issuer
SAMR / Standardization Administration of China
Status and context
Current official source checked; selected scope only
Edition or text examined
GB/T 27025-2019 / ISO/IEC 17025:2017
Relationship
National adoption
Legal character
Voluntary reference
Source check
2026-10-20
Applies to
The named Chinese publication and its officially recorded international-source relationship.
Scope and conditions
No protected technical clauses or test limits are reproduced.,This relationship does not establish NCQM accreditation, certification or regulatory acceptance.
Actions
Identify both national and international designations in the evidence record.
Use the stated adoption degree; examine national differences where the record is MOD.
Check separately which law, procurement specification or assessment programme selects the document.
Materials for the research review
Catalogue identity and adoption-degree record.
The edition and scope appearing on the actual certificate, report or specification.
Quality management: Chinese and international edition identity
Official national-standard catalogue record for GB/T 19001-2016
The SAMR catalogue identifies GB/T 19001-2016 as a identical adoption of ISO 9001:2015. The relationship belongs to those stated editions. The catalogue identifies this GB/T document as recommended. Adoption identity by itself does not make certification or product approval compulsory. A later international revision does not silently replace the source edition recorded for the Chinese publication.
Scope, actions and official sources
Issuer
SAMR / Standardization Administration of China
Status and context
Current official source checked; selected scope only
Edition or text examined
GB/T 19001-2016 / ISO 9001:2015
Relationship
National adoption
Legal character
Voluntary reference
Source check
2026-10-20
Applies to
The named Chinese publication and its officially recorded international-source relationship.
Scope and conditions
No protected technical clauses or test limits are reproduced.,This relationship does not establish NCQM accreditation, certification or regulatory acceptance.
Actions
Identify both national and international designations in the evidence record.
Use the stated adoption degree; examine national differences where the record is MOD.
Check separately which law, procurement specification or assessment programme selects the document.
Materials for the research review
Catalogue identity and adoption-degree record.
The edition and scope appearing on the actual certificate, report or specification.
The linked official sources establish the provisions, document identities or relationships examined. NCQM supplies original English analysis. Where an official source is in another language, the English explanation is not an official translation. Source-check dates, effective dates and adopted editions are kept separate.
The research review materials help organize an assessment. They are distinguished from evidence expressly identified by the source. International standards remain subject to their publishers’ access and rights conditions.
