Product Technical Requirements for China Medical Device Registration

1. Key takeaways

Product technical requirements are one of the seven categories in Article 14 of the Regulation on the Supervision and Administration of Medical Devices. Article 26 of the Medical Device Registration and Filing Measures (SAMR Order No. 47, published 26 August 2021, effective 1 October 2021) requires functional and safety specifications and test methods that can be objectively determined on the finished product.

• Objectively determinable is the first principle. It does not constrain how high a limit is set; it requires every specification to appear with a test method, with outcomes independent of tester judgement.
• Article 30 requires testing against the requirements, with a pass before trials or application; requirement defects pass straight through to testing.
• Test samples must be representative (Article 31). The report may be a self-test or one from a qualified testing institution (Article 32; Regulation Article 14).
• Applicable mandatory standards must be met; where one does not apply, an explanation and materials are submitted (Article 19). Silence and unexplained inapplicability are different errors.
• GRZAN’s assessment: such corrections are a high-frequency first-registration item, mostly removable before submission; express each specification as method, conditions and decision basis.

2. Legal basis

Administrative regulation. The Regulation (State Council Order No. 739, published 9 February 2021, effective 1 June 2021) provides:

• Article 14: the requirements are submitted with a test report, which may be a self-test or from a qualified institution.
• Article 17(2): forwarded to technical review within three working days of acceptance. Article 18(1): decision within twenty working days of the review opinion.
• Article 22: five-year certificate term; renewal filed six months before expiry.

Departmental rule. Order No. 47 specifies:

• Article 19: applicable mandatory standards met; where structure, intended use or method of use makes one inapplicable, reasons and materials are supplied.
• Article 26: the applicant prepares the requirements with objectively determinable functional and safety specifications and test methods, conforming to national mandatory standards.
• Article 27: instructions and labels must meet the Provisions on Instructions and Labels.
• Article 30: testing against the requirements must pass before trials, registration or filing.
• Article 31: test samples must represent the safety and effectiveness of the product applied for.
• Article 32: the report may be the applicant’s self-test or one from a qualified institution.
• Article 41: deficiencies notified in full at once, answered once within one year, otherwise review terminates with a refusal.
• Article 79: substantive changes require variation registration; other changes are filed within thirty days.
• Article 121: IVDs follow the separate IVD measures.

Instructions and labels. The Provisions (former CFDA Order No. 6, published 30 July 2014, effective 1 October 2014) require in Article 4 that content be scientific, true, complete and accurate and consistent with the registered content; in Article 8 that Class II and III names match the certificate; and in Article 9 that text be in Chinese.

Normative documents. Announcement No. 121 of 2021 places the requirements in the unified catalogue. No. 126 of 2021 governs self-testing, with the inspection guide of 16 September 2025. The QMS inspection guide (notice No. 50 of 2022) applies to on-site inspection. Announcement No. 63 of 2025, Part Four, clarifies review requirements further.

Practical estimate: clause numbering, body and annex division and limit justification depth have no unified published format; current practice and existing guidelines for the product type govern, so review them before drafting.

3. Expert insights

Three testable questions. Objectively determinable unpacks into three self-checks.

Most corrections stem not from low limits but from non-determinability: a phrase such as stable and reliable performance cannot be reproduced by a third party or recorded as pass or fail.

A closed loop of specification, method, sample and conclusion. Article 30 sets the order: test first, and only after a pass may trials or application proceed. Article 31 sets representativeness. Article 32 sets who may issue the report. What the requirements state is what gets tested; the samples determine the scope covered; the issuer determines the capability evidence attached. A common break is testing only some models without typical-model justification, inviting a challenge under Article 31.

Applicability must be stated explicitly. Three deviations recur: silence, which leaves review unable to tell omission from exclusion; wholesale citation of standards whose scope does not cover the product, creating new obligations; and thin explanation stating inapplicability without reasons grounded in structure, intended use or method of use. The correct approach is a judgement per standard, distinguishing full-text citation, clause citation and inapplicable with reasons, each traceable to a clause or characteristic.

High-frequency correction causes can be removed in advance.

Requirements connect to variation registration. Adjusting a specification or method usually constitutes a substantive change, requiring variation registration under Article 79; other changes are filed within thirty days. On limit tightness, too tight a limit means ordinary process variation may trigger a variation, while too loose a limit may be challenged as unable to assure safety; validation and process capability data should support it. On granularity, an overly detailed method locks process parameters while an overly coarse one may be judged non-determinable; state the standard number and decision rule in the body and keep operating parameters in a validated internal instruction.

Effect of Announcement No. 63 of 2025. Part Four makes review concerns more public, so requirements can move into design inputs rather than being addressed at correction stage. Use existing guidelines and review points as top-level items; for novel products, confirm through Article 22 communication and Article 23 consultation.

4. Practical recommendations

• Draft on a three-column pattern of specification, method and decision, flagging rows with a missing column.
• Verify that every cited standard is the current edition and year.
• Record a per-standard applicability judgement covering full citation, clause citation and inapplicable with reasons.
• Maintain an item mapping table linking requirements, test report results and instruction statements.
• Justify sample representativeness, including typical model selection and unit coverage.
• For self-testing, prepare capability, system and record-retention evidence under Announcement No. 126.
• Draft instructions, labels and requirements in parallel on a shared parameter baseline.
• Bring requirements into change monitoring, choosing between variation and thirty-day filing after any adjustment.

5. Verification checklist

• □ Requirements prepared under Regulation Article 14 and Order No. 47 Article 26?
• □ Every specification paired with a reproducible method citing standard number and year?
• □ No non-determinable wording such as good performance or stable and reliable?
• □ Applicable mandatory standards cited; inapplicable ones explained with materials (Article 19)?
• □ All cited standards current?
• □ Testing completed against the requirements with a pass (Article 30)?
• □ Test samples representative, with typical model justification under Article 31?
• □ Self-testing compliant with Announcement No. 126 and the inspection guide?
• □ Requirement items aligned with test report items?
• □ Product name matching the certificate; parameters consistent across the three documents?
• □ Chinese throughout, translations with originals (Article 17)?
• □ Requirement version matching the submission, archived copy retained?
• □ Variation or thirty-day filing route decided (Article 79)?
• □ Correction answered once within one year under Article 41?

Regulatory information verified as at 29 October 2026. Legal texts follow the versions published by NMPA, SAMR and gov.cn and must be rechecked after amendment or repeal. Time limits, fees and catalogue scope reflect the official position on that date; content marked practical estimate has 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 prepares NMPA-compliant dossiers, coordinates typetesting and clinical evaluation documents, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com