Stability Studies and Shelf Life for Medical Device Registration

1. Key takeaways

Stability studies are one of the nine non-clinical study types in Article 28 of the Medical Device Registration and Filing Measures (SAMR Order No. 47, published 26 August 2021, effective 1 October 2021). Their direct output is the shelf life claim and the transport stability conclusion.

• Expiry means performance and safety are maintained over the claimed period, not an empirical guess about how long a product still works; the validation design must rest on objectively determinable specifications.
• Accelerated and real-time ageing are a time-sequenced combination, not alternatives: accelerated data support an early claim, real-time data confirm it, and the filing must state how the two combine and what follows.
• Article 29 requires method validation, and where statistics apply, the statistical method, sample size basis and acceptance criteria; ageing time points, sample numbers and decision limits fall under it. Article 31 requires samples to represent the product applied for, including sterilisation, packaging and storage.
• GRZAN’s assessment: stability is the easiest area to under-resource and the easiest to expose at correction stage, because a claim written into the instructions needs evidence that takes time to accumulate and cannot be produced on request.

2. Legal basis

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

• Article 5: supervision follows risk management, whole-process control, scientific oversight and social co-governance.
• Article 14: seven categories of materials, including risk analysis, technical requirements, test report and clinical evaluation.
• Article 20(1): the holder keeps an effective quality system and carries out post-market study and risk control.
• Article 22: five-year certificate term; renewal filed six months before expiry.

Departmental rule. Order No. 47 specifies:

• Article 19: applicable mandatory standards met; inapplicable ones explained with materials.
• Article 24: risk management across the life cycle. Article 26: objectively determinable specifications and test methods.
• Article 27: instructions and labels must meet the Provisions on Instructions and Labels.
• Article 28: the nine study types include stability. Article 29: method validation plus statistical method, sample size basis and acceptance criteria where statistics apply.
• Article 31: test samples must represent the product applied for.
• Article 41: deficiencies notified once in full, 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.

The Provisions (former CFDA Order No. 6) require in Article 4 that content be scientific, true, complete and accurate and consistent with the registered content, and in Article 16 that reviewed instruction content must not be changed without authorisation.

Normative documents. The Production Quality Management Practices (Announcement No. 107 of 2025, published 4 November 2025, effective 1 November 2026) contain fifteen chapters and 132 articles, adding chapters on quality assurance, validation and confirmation, and contract manufacturing; the 2014 announcement No. 64 is repealed. Announcement No. 121 sets the dossier catalogue; No. 126 governs self-testing; the QMS inspection guide (notice No. 50 of 2022) defines four outcomes; No. 63 of 2025 clarifies review requirements.

Practical estimate: accelerated and real-time temperatures, their conversion, time point density and packaging integrity methods have no clause-level numerical standard; current recommended standards, guidelines and review points govern. Search guidelines before finalising the protocol and retain the justification linking the two conditions.

3. Expert insights

A claim to be proved, not a parameter to be estimated. Shelf life printed in the instructions is reviewed content and cannot be altered unilaterally under Article 16, which turns it from a technical figure into a compliance obligation. Validation therefore has three parts: the claim, stating period and storage conditions; the proof, showing performance and safety still meet the requirements at that point; and the connection, aligning the end point with release, storage, transport and use. Missing any part leaves the claim unsupported; the common failure is a three-year claim with eighteen months of real-time data and accelerated data that cannot bridge the gap.

A time-sequenced combination.

The accepted combination is accelerated data for the claim plus continuing real-time confirmation, with the correspondence argued. The key action is a separate justification mapping accelerated to real conditions, not treating accelerated results as the conclusion.

Test items come from the technical requirements. Selection logic is time sensitivity plus relevance to safety and effectiveness, organised in three classes.

Testing everything makes cost and time uncontrollable and generates data needing explanation; testing too little misses the real ageing path. The basis comes from the risk file and ageing mechanism analysis, not habit.

Statistics as a checkable protocol design. Three points matter: why these time points, whether they cover the end of shelf life and include a boundary point; how many samples per point and on what basis, whether variability, test power or destructive constraints; and whether pass limits at the end point match the requirements, with reasons for any tightened or relaxed limit. All three must be in the protocol, not assembled in a correction response.

Transport stability is a separate claim.

For sterile devices the two intersect: whether packaging integrity survives transport affects sterility over shelf life, so transport studies should use the validated integrity method and feed the result into the shelf life argument.

Sample representativeness. Article 31 means the aged sample is the marketed product. Four break points recur: ageing without final sterilisation; packaging differing in material, size or sealing; a single batch without justification; and storage drifting from the protocol without monitoring records. State sample requirements in the protocol and keep environmental records throughout.

4. Practical recommendations

• Fix the claim before the protocol: decide the period and storage conditions to be printed, then design the study.
• Classify test items with the basis recorded in the risk file.
• Start accelerated and real-time ageing together so real-time data accumulates from day one.
• Write a separate justification for the accelerated to real-time correspondence.
• Fix time points, sample numbers and criteria in the protocol (Article 29).
• Age samples that are finally sterilised, in marketed packaging, with batch selection justified (Article 31).
• Design transport studies around transport events, feeding conclusions into packaging integrity.
• After changing expiry or storage conditions, decide between variation and thirty-day filing (Article 79).

5. Verification checklist

• □ Stability studies completed under Article 28, reasons recorded if omitted?
• □ Expiry and storage conditions settled (Provisions Articles 4 and 16)?
• □ Test items classified, basis in the risk file?
• □ Both ageing modes started, combination explained?
• □ Separate justification for the accelerated to real-time link?
• □ Time points cover the end of shelf life and a boundary point?
• □ Sample size per point and its basis stated (Article 29)?
• □ End-point limits match the requirements, differences explained?
• □ Methods validated, including a confirmed packaging integrity method?
• □ Aged samples sterilised, in marketed packaging, batch justified (Article 31)?
• □ Environmental records kept throughout?
• □ Transport studies designed around events, linked to packaging integrity?
• □ Cited standards current; inapplicable ones explained (Article 19)?
• □ After expiry or storage changes, variation or thirty-day filing decided (Article 79)?

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