Non-Clinical Evaluation Data as an Independent Evidence Pillar

1. Key takeaways

Article 10(2) of the Implementation Rules lists, in item (10), the non-clinical evaluation material alongside item (9) clinical evaluation material as mandatory registration documents. This means non-clinical evidence is not an appendage of the clinical evaluation but an independent pillar of proof. In the second exemption scenario for clinical evaluation — cases in which the safety and effectiveness of the medical device can be demonstrated through non-clinical evaluation — the non-clinical evaluation material must even carry the conclusions on safety and effectiveness on its own.

• Items (9) and (10) are two separate list entries; preparing only one of them is a documentary gap.
• Such gaps surface during the 20 working day formal review stage.
• When clinical evaluation is exempted, the non-clinical material must cover both safety and effectiveness.
• Non-clinical evidence, technical requirements and the summary test report form a triangular verification.
• Software and cybersecurity evidence should be expressly located within the dossier index.

2. Legal basis

The obligation rests on the attachment list of the Implementation Rules, reinforced by the refusal provision of the founding law and the exemption ruling that defines when non-clinical evidence must stand alone. The classification ruling supplies the technical requirement framework that the non-clinical data must reflect.

3. Expert insights

First observation: the parallel placement sets the completeness standard for the dossier. Items (9) and (10) are two independent entries on the attachment list, and preparing only one of them constitutes a documentary gap that will be discovered during the 20 working day formal review stage. This is one of the most easily overlooked formal errors before submission. Teams accustomed to jurisdictions where a single combined evaluation document is filed should restructure their material, because Macao’s list format expects two separately identified components. Each component should carry its own title page, conclusions section and cross-references, so that the reviewer can immediately confirm that both entries of the attachment list are satisfied by distinct, complete documents rather than by fragments of a single combined file.

Second observation: when clinical evaluation is exempted, the burden of proof on non-clinical evaluation increases. The second category of scenarios in Ruling No. 5/ISAF/2026 requires that the safety and effectiveness of the device can be demonstrated through non-clinical evaluation. In that situation the non-clinical material is no longer a supporting player: it must cover both the safety dimension and the effectiveness dimension. Bench data, verification and validation results, and performance testing must be organised so that each of the two conclusions can be traced to named evidence, with an explicit acceptability judgement at the end of each chapter. Verification activities that support only one of the two dimensions should be identified as such in the chapter structure, so the reviewer can see at a glance which conclusion each dataset serves and where the remaining gaps, if any, have been closed by other evidence in the dossier.

Third observation: non-clinical evidence, the technical requirements and the summary test report form a triangular verification. The technical requirements (item (7)) define the indicators, the summary test report (item (8)) evidences conformity, and the non-clinical evaluation material (item (10)) argues safety and performance. The device models, technical parameters and standard versions cited in the three documents must be completely consistent; inconsistencies are a frequent cause of file requests. A cross-reference table built during compilation catches these mismatches before the reviewer does. The table should be updated whenever any of the three documents is revised, and a final consistency pass immediately before submission is the cheapest safeguard against a suspended assessment clock.

Fourth observation: the placement of software and cybersecurity evidence deserves attention. For devices incorporating software, cybersecurity and software lifecycle evidence should be placed within the non-clinical evaluation material or expressly listed in the technical requirements, so that the reviewer can locate them without searching (practical estimate). Embedded software of unknown provenance, update mechanisms and data interfaces are the areas reviewers probe most; burying this evidence in annexes without index entries invites a file request and suspends the assessment clock.

4. Practical recommendations

• Prepare items (9) and (10) as two separate documents: do not merge them, and do not let one substitute for the other by cross-reference alone.
• Where clinical evaluation is exempted, organise the non-clinical material around the two dimensions of safety and effectiveness: allocate a dedicated chapter and a stated conclusion to each dimension.
• Build a model and parameter cross-reference table: keep the citations in the technical requirements, the test report and the non-clinical material uniform.
• Assign software evidence a clear home: state in the dossier index where the cybersecurity and lifecycle evidence is located.

5. Verification checklist

• □ Clinical evaluation material (item (9)) and non-clinical evaluation material (item (10)) have been compiled separately
• □ Where clinical evaluation is exempted, the non-clinical material covers both safety and effectiveness
• □ Models and parameters are fully consistent with the technical requirements and the summary test report
• □ Standard versions are uniform across the three documents
• □ Software and cybersecurity evidence is located in the dossier index
• □ Completeness of the material has been confirmed to avoid gaps at formal review

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for Macao, China. Our team prepares SSM-compliant dossiers, coordinates language and legalisation requirements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com