Standards System: Mandatory, Recommended Standards and Technical Requirements

1. Key takeaways

The standards system rests on three parallel instruments whose binding force comes from different sources.

• Applicability is the rule, exclusion the exception. Article 19 of Order No. 47 requires conformity with applicable standards, and a statement with data where a standard does not apply.
• Technical requirements are the test criterion. Under Article 30, testing follows the technical requirements, and only passing products may enter a trial or be filed.
• Recommended standards change status when written in. Once confirmed at review, the indicator becomes a release criterion.
• Both types fall within review. Whether a non-applicability statement holds is decided by the reviewer, not by the applicant.

The GRZAN view. The failure is rarely ignorance of standards but too coarse an applicability judgment. Searching by product name and applying everything found is common; judging each standard against structure, purpose and use prevents rewriting the technical requirements.

2. Legal basis

Administrative regulation. Regulations on Supervision and Administration of Medical Devices, State Council Order No. 739, promulgated 9 February 2021, effective 1 June 2021. Article 6 requires risk assessment against intended purpose, structure and use; Article 14(2) allows a report from the applicant or a qualified institute; Article 34 binds a contract manufacturer to mandatory standards and the product technical requirements; Article 39 requires compliant instructions and labels.

Departmental rules. SAMR Order No. 47, promulgated 26 August 2021, effective 1 October 2021: Article 19 requires conformity with applicable mandatory standards and a statement with data where a standard does not apply; Article 26 requires requirements drafted to the NMPA guideline with indicators and methods objectively judged on the finished device; Article 28 defines non-clinical studies from performance to sterilisation and stability; Article 30 requires testing against the technical requirements before a trial or filing; Article 31 requires test samples to represent the applied product; Article 32 allows in-house or commissioned testing; Article 79 requires a variation where certificate entries change; Article 121 refers IVDs to Order No. 48. SAMR Order No. 53, promulgated 10 March 2022, effective 1 May 2022, requires a licence for Classes II and III and filing for Class I (Article 4). Former Order No. 6, promulgated 30 July 2014, effective 1 October 2014, requires instructions and labels to be scientific, true, complete and consistent with the registered content (Article 4).

Normative documents. Announcement No. 121 of 2021, published 29 September 2021, effective 1 January 2022, sets the format and position of the technical requirements in the submission; No. 126 of 2021, published 21 October 2021, governs self-testing, supported by the guideline issued on 16 September 2025; No. 30 of 2025, issued 17 March 2025, excludes the technical requirements and test reports from materials reusable when an imported device moves to local production, since they must show conformity with Chinese mandatory standards; No. 63 of 2025, issued 27 June 2025, improves standards supply for robots, high-end imaging, artificial intelligence and new biomaterials; No. 107 of 2025, issued 4 November 2025 and effective 1 November 2026, has 15 chapters and 132 articles.

Practical estimate. The NMPA publishes current mandatory and recommended standards dynamically, so search by product category at project start, not from an earlier list. For an innovative product with no applicable standard, the gap does not remove the testing duty; own methodology and non-clinical data must fill it.

3. Expert insights

Applicability is judged item by item. Article 19 uses two clauses: conformity with applicable standards, and a statement where a standard does not apply. The factors match those used in classification. Record each standard as applicable, not applicable or partly applicable, naming the clause for partial application; a general conformity claim is returned.

A non-applicability statement is evidence, not a sentence. Article 19 requires supporting data, and an acceptable statement has three parts.

The third part is often omitted; the burden moves to method validation, non-clinical or equivalence data; without it the statement fails.

Recommended standards have two states. Before inclusion they are voluntary; once confirmed in the technical requirements, the indicator enters the test scope under Article 30 and any change needs a variation under Article 79. More indicators mean less freedom to change; Article 26 rejects wording such as compliant, suitable or good.

Standards, requirements and testing form one chain. Applicable mandatory standards plus adopted recommended standards feed the technical requirements, which set objectively judged indicators and methods, which drive testing, which must pass before filing. A break returns the file to the start.

An indicator without a method cannot be executed, and a sample differing from production is challenged at inspection.

Standard updates reach existing certificates. A stricter standard may require an Article 21 assessment and a variation; an editorial change can wait until renewal; a requirement citing an old edition goes stale once the standard is revised. Cite the current effective edition and log the edition relied on.

Imported products follow a separate transition rule. Announcement No. 30 of 2025 allows reuse of the summary, non-clinical materials other than the technical requirements and test reports, and clinical evaluation, but not the requirements and reports themselves.

GB and YY standards transpose IEC and ISO differently, so even without a design change the requirements and reports must be redrafted and retested; foreign data alone will be returned.

4. Practical recommendations

• Build a standards list at kick-off. Record number, title, mandatory or recommended status, conclusion and rationale, and file it with the classification decision.
• Write exclusions in three parts. Facts, reasoning and alternative evidence; the third decides acceptance.
• Pair every indicator with a method. Article 26 requires objective judgment, so state the method source and acceptance criterion.
• Cost the change before adopting a recommended standard. Inclusion brings the indicator into the test scope, and later adjustment needs a variation under Article 79.
• Keep test samples consistent with production. Freeze design and configuration before sampling, and retain the configuration list and sample records.
• Cite the current effective edition. Avoid fixed edition numbers and record the edition in the register.
• Monitor standard updates post-market. Assess whether a revised mandatory standard constitutes a substantial change under Article 21.
• Treat local production as a new project. Under Announcement No. 30 of 2025 the technical requirements and test reports are redrafted and retested, so schedule the full workload.

5. Verification checklist

• □ Structure, purpose and use documented for applicability.
• □ Current standards list compiled by product category.
• □ Each standard marked applicable, excluded or partly applicable, with clauses named.
• □ Non-applicability statements written in three parts under Article 19.
• □ Alternative evidence for exclusions complete.
• □ Every indicator objectively judged and paired with a method.
• □ No wording such as compliant, suitable or good.
• □ Change cost assessed for adopted recommended standards.
• □ Standards cited as the current effective edition, with the edition logged.
• □ Test items cover every indicator.
• □ Test samples represent the applied product, with design frozen.
• □ Test report source settled, in house or commissioned under Article 32.
• □ Self-testing meets Announcement No. 126 of 2021 and the 2025 guideline.
• □ Local production projects redraft the requirements and reports under Announcement No. 30 of 2025.

Verified as at 29 October 2026 against NMPA, SAMR and State Council publications; practical estimates have no legal effect.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Chinese market. Our team manages National Medical Products Administration (NMPA) registrations, coordinates typetesting at qualified testing institutes, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com