Self-Testing in China Registration: Capability Requirements and the 2025 Inspection Guideline

1. Key takeaways

The Provisions on Self-Testing in Medical Device Registration (Announcement No. 126 of 2021) were published on 21 October 2021 and took effect on publication. A self-test report and an entrusted test report are two parallel routes.

• The choice rests on testing capability, not cost or convenience. Article 32 of the Measures (SAMR Order No. 47) and Article 14 of the Regulation both allow the report to be self-issued or issued by a qualified testing institution.
• Self-testing is not testing it yourself: it requires testing capability covered by the quality system, with five elements — personnel, equipment, method, environment and records — all present.
• Test articles must be representative (Article 31). In self-testing the sample moves internally, so batch consistency is the weakest link.
• The Self-Test Inspection Guideline was issued by the NMPA general office on 16 September 2025, giving inspection an operating standard.
• A self-test report in the submission triggers a self-test capability inspection within the registration quality system inspection (Articles 47 to 49, plus the 2022 guideline).
• Mixed submissions, part self-test and part entrusted, require the boundary between the two to be stated explicitly in the dossier.

2. Legal basis

Administrative regulation. Medical Device Supervision and Administration Regulation (State Council Order No. 739), promulgated 9 February 2021, effective 1 June 2021. Article 13: Class I filed, Class II and III registered, with lifecycle liability. Article 14: the seven categories of documents for filing and registration, the product test report being either self-issued or issued by a qualified testing institution. Article 20, paragraph 1: five duties, the first concerning the quality system.

Departmental rules. Measures for the Administration of Medical Device Registration and Filing (SAMR Order No. 47), promulgated 26 August 2021, effective 1 October 2021.

• Article 15: quality system. Article 26: who drafts the product technical requirements, and their content (objectively judgeable functional and safety indicators and test methods).
• Article 28: scope of non-clinical studies. Article 29: method validation and statistical analysis.
• Article 30: testing against the product technical requirements, with a conforming result before trials, registration or filing. Article 31: test articles must be representative. Article 32: the report may be self-issued or issued by a qualified institution.
• Articles 47 to 49: organisation and focus of the registration quality system inspection.

Normative documents. Provisions on Self-Testing in Medical Device Registration (Announcement No. 126 of 2021), 21 October 2021, effective on publication. Self-Test Inspection Guideline for Medical Device Registration (NMPA general office, 16 September 2025), whose clause 3.3 covers inspection points (wording outside the verification scope here; the text in force governs). Registration Quality Management System Inspection Guideline (Notice No. 50 of 2022), 29 September 2022, effective on issue, repealing Notice No. 19 of 2020.

Practical estimate. Qualification thresholds for self-test laboratory staff, calibration and intermediate check intervals, the rule for splitting self-tested and entrusted items, and the signing and archiving requirements for self-test reports are not held here as verified text. The description below is industry practice and a practical estimate; build the capability against Announcement No. 126 and the 2025 guideline in force.

3. Expert insights

Two parallel routes, chosen on capability rather than convenience. Article 14 of the Regulation and Article 32 of the Measures present the two forms as fully parallel, with no priority between them.

The usual misjudgement looks only at one project’s cost: self-testing appears to save the fee but brings forward the fixed cost of capability and adds an inspection line at filing.

Five elements must be covered by the system. Capability exists only where the testing activity is inside the quality system.

The fourth row is the most overlooked: on temperature-sensitive tests, a missing continuous record undermines the result.

Representativeness of test articles is the weakest link. Article 31 requires representative articles, and Article 30 requires a conforming result before trials or filing. Where the sample moves internally, the burden of proving representativeness is heavier.

The fourth row is fatal: a change after testing leaves the report describing a state that no longer matches the filed product. With entrusted testing, despatch exposes the change naturally; in self-testing the internal route removes that external check (practical estimate).

The self-test report adds an inspection branch to the filing schedule. Articles 47 to 49 set the organisation and focus of the registration system inspection, and the 2022 guideline details the points. A self-test report extends the inspection to capability.

Mixed submission is the most complex: items must be divided and marked in the dossier, since an unclear boundary leaves the team unable to confirm capability coverage (practical estimate).

The 2025 guideline turns principle into operation. Announcement No. 126 established the regime; the guideline answers how it is inspected.

With the guideline, grey areas such as partly outsourced items are more readily decided (practical estimate).

4. Practical recommendations

• Choose the route by product line: long lines with frequent iteration suit self-testing; single lines needing special equipment suit entrusting (practical estimate).
• Build a capability list across the five elements, with verifiable evidence for each; a missing element bars self-testing.
• Keep a separate batch traceability record for test articles, covering source, batch, conditions and final status as proof of representativeness (Article 31).
• Freeze the design state after testing, so any change before filing triggers a retest decision.
• Divide item boundaries in mixed submissions, listing self-tested and entrusted items and their basis rather than a general statement.
• Put capability inspection preparation into the filing plan, since a self-test report triggers it (Articles 47 to 49).
• Plan alongside the 2026 manufacturing practice conversion: method validation (Article 29), calibration and record control overlap with the validation chapter of Announcement No. 107 (15 chapters, 132 articles), and joint planning avoids rework (practical estimate).

5. Verification checklist

• □ Route confirmed and its basis stated (Article 32; Article 14)
• □ Capability covers five elements, each with evidence
• □ Test methods validated (Article 29)
• □ Equipment in calibration and intermediate checks recorded
• □ Test articles representative, batch and records traceable (Article 31)
• □ Conforming result obtained before trials, registration or filing (Article 30)
• □ Any design change after testing has triggered a retest decision
• □ Mixed submissions state the item boundary in the dossier
• □ Inspection preparation time reserved (Articles 47 to 49)
• □ Raw records complete, traceable and amended with an audit trail
• □ Capability build aligned with the Announcement No. 107 conversion (effective 1 November 2026)

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 adverse event monitoring and recall filings with NMPA, maintains UDI compliance, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com