Research on defined product requirements and the use of standards in Türkiye. Each record identifies its scope, source and practical evidence questions.
Market scope
EU alignment does not prove identical text, dates or Turkish implementation.
The records below examine specific provisions and standards relationships. They do not combine different products or regulatory roles into one approval route.
Product Safety and Technical Regulations Law No. 7223 · Article 7(1)(b) and (c)
The manufacturer must prepare the technical file, carry out the assessment and issue the conformity documents required by the applicable legislation. Retention follows the period in the technical regulation; where none is stated, the Law provides a minimum of ten years from placing the product on the market. The file should therefore be governed by the product’s actual regulatory route.
Scope, actions and official sources
Issuer
Turkish legislature
Status and context
Operative provision or documented programme relationship; official sources checked on 2026-10-20.
Legal character
Binding within the stated scope
Source check
2026-10-20
Applies to
Manufacturers placing products on the Turkish market, subject to the applicable technical regulation and the Law’s scope.
Scope and conditions
The clause does not require a declaration or conformity mark where the applicable legislation does not require one.
Actions
Identify the applicable technical regulation and its assessment route.
Prepare the required conformity documents and preserve them for the applicable period.
Evidence identified by the source
Technical file and conformity documents where required by the relevant legislation.
Materials for the research review
File index linked to model and design revision.
Retention schedule showing the applicable rule and market placement date.
Importer checks before placing a product on the market
Product Safety and Technical Regulations Law No. 7223 · Article 9(1)(b)
Before market placement, the importer must check the required conformity markings and accompanying documents, and confirm the manufacturer has fulfilled the referenced technical documentation and identification duties. This is a release decision for the imported configuration. A supplier’s statement that a product is “European compliant” does not identify which Turkish rules, marks and documents have actually been checked.
Scope, actions and official sources
Issuer
Turkish legislature
Status and context
Operative provision or documented programme relationship; official sources checked on 2026-10-20.
Legal character
Binding within the stated scope
Source check
2026-10-20
Applies to
Importers placing products covered by the Law on the Turkish market.
Scope and conditions
The checks depend on the applicable legislation; a CE mark is not required on every product.
Actions
Identify the required markings and accompanying documents.
Verify the manufacturer’s Article 7(1)(b), (e) and (f) duties before release.
Evidence identified by the source
Required conformity markings and accompanying documents; confirmation of the referenced manufacturer duties.
Materials for the research review
Receiving inspection against model, packaging and document revisions.
Release record identifying the person who performed the checks.
Product Safety and Technical Regulations Law No. 7223 · Article 12(1) and (2)
Economic operators must systematically record the preceding and, where applicable, following operator and other information needed to trace a product. The records must be retained for at least ten years from placing or making it available on the market and supplied on request. The provision also expressly addresses electronic commerce and specified intermediaries, so traceability cannot stop at the warehouse ledger.
Scope, actions and official sources
Issuer
Turkish legislature
Status and context
Operative provision or documented programme relationship; official sources checked on 2026-10-20.
Legal character
Binding within the stated scope
Source check
2026-10-20
Applies to
Economic operators, including the online and intermediary activities described in Article 12(2).
Scope and conditions
The downstream record concerns the next economic operator where one exists; it is not a blanket requirement to identify every individual retail consumer.
Actions
Record upstream and applicable downstream operator identity and contact details.
Preserve traceability information and make it available to the authority on request.
Evidence identified by the source
Operator and product traceability records retained for at least ten years.
Materials for the research review
Batch-to-purchase and batch-to-dispatch reconciliation.
Sample retrieval exercise covering an online order and a distributor shipment.
Product Safety and Technical Regulations Law No. 7223 · Article 19(1)–(3)
Where other measures cannot eliminate the risk, the operator must recall the product voluntarily or at the authority’s request. The notice must include the return or repair contact points and the options offered to end users. At least one statutory remedy must be offered: correction of the problem, payment of the specified retail value, or replacement with a safe compliant equivalent.
Scope, actions and official sources
Issuer
Turkish legislature
Status and context
Operative provision or documented programme relationship; official sources checked on 2026-10-20.
Legal character
Binding within the stated scope
Source check
2026-10-20
Applies to
Economic operators where other measures are insufficient to eliminate the product risk.
Scope and conditions
Recall is triggered by the stated risk circumstances; it is not the same as every ordinary commercial return.
Actions
Determine whether other measures can eliminate the risk.
Publish the required notice and provide at least one of the Article 19(3) remedies.
Evidence identified by the source
Recall notice containing the required contact and remedy information.
Materials for the research review
Affected model and batch population.
Notice distribution log and reconciliation of returned, repaired or replaced units.
Notification when a consumer product presents a safety risk
General Product Safety Regulation · Article 9(1) and (2)
A producer or distributor that knows, or should know from its professional information, that a marketed product presents consumer safety risks must promptly give the competent authority detailed information about those risks, corrective measures and results. Serious risk notifications require additional product identification and risk details. Internal complaint escalation should therefore lead to an authority notification decision, rather than ending with a customer service response.
Scope, actions and official sources
Issuer
Turkish Ministry of Trade
Status and context
Operative provision or documented programme relationship; official sources checked on 2026-10-20.
Legal character
Binding within the stated scope
Source check
2026-10-20
Applies to
Producers and distributors of products within the General Product Safety Regulation’s scope.
Scope and conditions
Sector legislation may govern risks already covered by specific rules; check the Regulation’s scope before using this general route.
Actions
Escalate safety information to the responsible decision maker.
Notify the competent authority promptly when the Article 9 condition is met.
Evidence identified by the source
Risk and corrective measure information, including the additional details required for a serious risk.
Materials for the research review
Incident assessment and notification decision with dates.
Copies of the authority communication and subsequent corrective action updates.
Declaration language and combined regulatory coverage
CE Marking Regulation · Article 11(2) and (3)
The declaration must follow the relevant module and the prescribed declaration form unless the technical regulation provides otherwise. A declaration in another language requires a Turkish translation. Where several applicable technical regulations require an EU declaration, the manufacturer may demonstrate all applicable rules in a single declaration identifying those regulations. The review should check regulatory coverage as well as the signature and product identity.
Scope, actions and official sources
Issuer
President of Türkiye
Status and context
Operative provision or documented programme relationship; official sources checked on 2026-10-20.
Legal character
Binding within the stated scope
Source check
2026-10-20
Applies to
Products subject to Turkish technical regulations that require an EU declaration of conformity and CE marking.
Scope and conditions
This provision does not place all products within CE marking rules, and it does not substitute for the applicable product regulation.
Actions
Check the product regulations requiring a declaration.
Provide the Turkish translation where the declaration is in another language.
Identify all applicable regulations in a combined declaration.
Evidence identified by the source
Declaration with the required contents and Turkish translation where applicable.
Materials for the research review
Declaration-to-file comparison for each cited regulation.
Version control showing that later product or regulatory changes have been considered.
These records distinguish adoption, legal incorporation, designation and programme recognition. A standard’s use is assessed within the specific relationship recorded.
Standards relationship · TR-R01
Turkish publication of the ISO 9001 quality management standard
TS EN ISO 9001:2015 · National publication and TSE management system certification programme
TSE’s own publication records that it published the 2015 ISO 9001 revision as TS EN ISO 9001:2015 in January 2016. Its 2024 activity report separately records use of that designation in system certification. These sources support the national publication and programme relationship; they do not establish that a particular supplier holds a current certificate or that a particular product is certified.
Scope, actions and official sources
Issuer
Turkish Standards Institution (TSE)
Status and context
Published national designation and documented programme use; latest catalogue status must be checked for the intended transaction.
Edition or text examined
2015
Relationship
National adoption
Legal character
Voluntary reference
Source check
2026-10-20
Applies to
Organizations researching the Turkish national designation and the TSE quality management certification route.
Scope and conditions
National publication and system certification do not by themselves establish product approval or a universal legal certification duty.
Actions
Use the exact national designation when identifying the selected document.
Check current catalogue status and the actual certificate scope before relying on certification.
Evidence identified by the source
For a certification claim, a valid certificate covering the organization and activities claimed.
Materials for the research review
Catalogue record and licensed copy reference.
Certificate issuer, scope, sites and current status check.
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
TSE’s official activity report identifies ISO 13485:2016 in its management system certification scope and lists certificates under TS EN ISO 13485:2016. This establishes an official programme relationship to the medical device quality management standard. A device supplier review should match the actual certificate to the manufacturing activities and sites involved, then examine the separate regulatory evidence for the device.
Scope, actions and official sources
Issuer
Turkish Standards Institution (TSE)
Status and context
Programme use documented in TSE official publications; individual certificate validity requires a separate live check.
Edition or text examined
ISO 13485:2016 as listed in the report
Relationship
Programme use or recognition
Legal character
Recognised for the stated purpose
Source check
2026-10-20
Applies to
Organizations evaluating the TSE medical device quality management system certification programme.
Scope and conditions
A management system certificate does not establish device marketing authorization, clinical performance or conformity of every device.
Actions
Identify whether the claimed certification covers the relevant device activities.
Verify the actual certificate and current certification body accreditation scope.
Evidence identified by the source
Certificate and scope when certification under this programme is claimed.
Materials for the research review
Covered sites, activities and exclusions.
Separate device conformity and marketing authorization records.
TÜRKAK testing and calibration laboratory accreditation · Laboratory accreditation basis and EA MLA testing/calibration scopes
TÜRKAK identifies TS EN ISO/IEC 17025 as the basis for testing and calibration laboratory accreditation. Its official account of the EA decision confirms testing and calibration within its maintained recognition scopes. For a product file, the useful evidence is the laboratory’s current scope covering the method, material and range used, together with a report that identifies the tested configuration.
Scope, actions and official sources
Issuer
Turkish Accreditation Agency (TÜRKAK)
Status and context
Operative provision or documented programme relationship; official sources checked on 2026-10-20.
Relationship
Programme use or recognition
Legal character
Recognised for the stated purpose
Source check
2026-10-20
Applies to
Testing and calibration laboratories seeking TÜRKAK accreditation and users assessing laboratory competence.
Scope and conditions
Accreditation is limited to the laboratory’s approved activities; it does not approve every report or create automatic acceptance by every regulator.
Actions
Check the laboratory’s current accreditation status and detailed scope.
Match the proposed test method and range to that scope.
Evidence identified by the source
Accreditation certificate and scope where accredited testing or calibration is required by the applicable route.
Materials for the research review
Report identification of method, sample and configuration.
TÜRKAK transition to ISO 15189:2022 for medical laboratories
TÜRKAK ISO 15189:2022 transition policy · Published ISO 15189 transition announcement and medical laboratory programme
TÜRKAK’s published transition policy identifies ISO 15189 as the basis for medical laboratory accreditation and explains the transition from the earlier edition to ISO 15189:2022. Its current training programme uses the Turkish national designation TS EN ISO 15189:2023. These different year designations should be recorded accurately rather than treated as contradictory laboratory certificates or substituted without checking the actual scope.
Scope, actions and official sources
Issuer
Turkish Accreditation Agency (TÜRKAK)
Status and context
Operative provision or documented programme relationship; official sources checked on 2026-10-20.
Edition or text examined
ISO 15189:2022
Relationship
Programme use or recognition
Legal character
Recognised for the stated purpose
Source check
2026-10-20
Applies to
Medical laboratories and organizations selecting accredited medical laboratory services.
Scope and conditions
This is a laboratory accreditation relationship, not medical device certification or a claim that every clinical test is within scope.
Actions
Identify the ISO edition and national designation stated on the current accreditation records.
Check the laboratory’s approved examination scope and current status.
Evidence identified by the source
Current accreditation certificate and scope when accredited medical laboratory service is claimed.
Materials for the research review
Transition completion evidence where relevant to older records.
Examination, sample type and site matched to the scope.
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.
