Clinical Evaluation Data: Three Pathways and Exemption Rules

1. Key takeaways

Article 14 of Law No. 12/2025 establishes the clinical evaluation obligation, and Article 10(2)(9) of the Implementation Rules lists clinical evaluation material as a mandatory registration document. There are three pathways: exemption (two scenarios under Ruling No. 5/ISAF/2026), comparison with an equivalent device (clinical literature, clinical experience and clinical trial data of the equivalent device), and conducting clinical trials (where existing evidence is insufficient; trials conducted in Macao require prior authorisation from ISAF). The compilation requirements are set down in Ruling No. 2/ISAF/2026, on the specific requirements for clinical evaluation of medical devices.

• The three pathways form an ordered progression, not a free choice: exemption first, equivalent-device comparison second, trials last.
• Equivalent-device evidence may combine clinical literature, clinical experience and clinical trial data.
• Foreign clinical data are usable, but equivalence must be argued across three elements.
• Innovative devices may obtain ISAF opinions at key stages of their trials under Article 12(2).
• Trials in Macao require a prior licence under Ruling No. 4/ISAF/2026, and trial conduct follows the GCP ruling No. 3/ISAF/2026.

2. Legal basis

Clinical evaluation is anchored in the founding law and given procedural flesh by four ISAF rulings: one on the specific requirements of clinical evaluation, one listing the exempted devices, one adopting the good clinical practice rules, and one governing authorisation of trials. The Implementation Rules fix where the material sits in the dossier and preserve the consultation mechanism for innovative devices.

3. Expert insights

First observation: the three pathways are ordered from easier to harder, not freely selectable. The logic is: first judge whether exemption is possible; if not, judge whether equivalent-device evidence suffices; only where that remains insufficient conduct clinical trials. Reversing the order — running a trial first and looking for an exemption afterwards — is the classic waste of resources. The evaluation plan should record the stepwise reasoning in writing, because that record is itself part of the clinical evaluation material and demonstrates to ISAF that the pathway chosen is the least burdensome one supported by the evidence.

Second observation: the sources for equivalent-device comparison are a choose-many of three. The official wording refers to clinical literature, clinical experience and clinical trial data of the equivalent device, among other material — the three categories may be used in combination. For products with an existing overseas marketing history, clinical literature and clinical experience often already suffice to support the evaluation. The comparison exercise is documentary rather than experimental: what matters is the systematic retrieval, appraisal and synthesis of the published and accumulated evidence. Retrieval strategies, inclusion criteria and the appraisal of each source should be described in the evaluation report itself, so that the reviewer can reconstruct how the conclusion was reached.

Third observation: the usability of foreign clinical data is the question manufacturers from the Chinese mainland care about most. The provisions do not require the data to originate from Macao; but the recognition of an equivalent device must be argued. The consistency of the device with the marketed comparator in technical characteristics, biological characteristics and clinical use is the core of that argument (practical estimate; the specific requirements of Ruling No. 2/ISAF/2026 prevail). Where populations or use environments differ, the dossier must address those differences and their impact on the conclusions drawn.

Fourth observation: innovative devices may obtain ISAF opinions at key stages of their clinical trials. Article 12(2) provides that ISAF may express opinions or give suggestions on the next stage of the research plan. For innovative products that must conduct trials, this step significantly reduces the risk of a plan being rejected. Using the consultation mechanism turns the regulator from a final gatekeeper into an early interlocutor, and the exchanged opinions become part of the documented development history. Applicants should frame the consultation questions narrowly, on the points where the study design genuinely carries regulatory risk, so that the opinions obtained are specific enough to be implemented.

4. Practical recommendations

• Assess along the three-pathway sequence: exemption, then equivalent-device comparison, then clinical trials, advancing layer by layer and keeping written records of each judgement.
• Argue equivalence across all three elements: consistency in technical characteristics, biological characteristics and clinical use — none of the three may be omitted.
• State the source and comparability of foreign data: explain population differences, differences in the setting of use, and their impact on the conclusions.
• Consult early for innovative products that must run trials: use the key-stage consultation mechanism of Article 12(2).

5. Verification checklist

• □ Applicability of exemption has been assessed under Ruling No. 5/ISAF/2026
• □ Where exemption fails, the equivalent-device argument has been completed across the three elements
• □ The three sources — clinical literature, clinical experience, clinical trial data — have been mapped
• □ Foreign data are accompanied by source and comparability statements
• □ Trials requiring authorisation have applied for the prior licence under Ruling No. 4/ISAF/2026
• □ Innovative devices have used key-stage consultation to obtain ISAF opinions

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