Clinical Evaluation Requirements and Exemptions for Medical Devices

1. Key takeaways

Article 14 of Law No. 12/2025 requires medical devices to undergo clinical evaluation; however, Dispatch No. 5/ISAF/2026 on the catalogue of medical devices exempted from clinical evaluation lists 2 categories of exemptions: (1) devices with a clear working mechanism, finalised design and mature manufacturing processes, that do not change conventional uses, and whose similar devices have been in clinical use for many years with no record of serious medical device adverse events; and (2) other situations in which the safety and effectiveness of the medical device can be demonstrated through non-clinical evaluation. Outside the exemptions, clinical evaluation may be conducted using materials such as the clinical literature, clinical experience and clinical trial data of similar devices; a clinical trial is needed only where the existing evidence is insufficient to demonstrate safety and effectiveness.

• The first exemption category rests on 4 cumulative elements, all of which must be established together.
• The absence of a record of serious adverse events requires evidence, not a mere declaration.
• The second category is a catch-all with a demanding threshold: non-clinical evidence must independently support both safety and effectiveness.
• Exemption from clinical evaluation does not exempt the applicant from submitting clinical evaluation documents with an exemption argument.
• The similar-device comparison route should be preferred over a new trial wherever the clinical literature, clinical experience or clinical trial data of similar devices can carry the case.

2. Legal basis

The duty of clinical evaluation, the exemption catalogue and the required documents are governed by the following instruments, verified as of 29 October 2026.

3. Expert insights

Insight 1: the 4 elements of the first exemption category are cumulative. A clear working mechanism, a finalised design and mature manufacturing processes, no change to conventional uses, and years of clinical use of similar devices without a record of serious adverse events — all 4 must hold at the same time. Companies often argue only the first 2 and overlook the element of no record of serious adverse events, which requires active proof.

Insight 2: the absence of a record of serious adverse events requires evidence, not a single declaration. This element requires the applicant to provide evidence of the safety history of similar devices, which usually comes from the vigilance databases of overseas regulatory authorities, public literature, and the company’s internal complaint and adverse event records. The quality of this evidence directly determines whether the exemption is accepted.

Insight 3: the second exemption category is a catch-all, but its threshold is not low. The phrase other situations in which safety and effectiveness can be demonstrated through non-clinical evaluation means that the non-clinical evidence must independently support both conclusions, of safety and of effectiveness. For most invasive or implantable products, non-clinical evidence can hardly demonstrate clinical effectiveness on its own — such products should proceed directly to planning a clinical evaluation.

Insight 4: exemption from clinical evaluation does not mean exemption from clinical evaluation documents. Article 10(2), item (9) of the Implementing Rules lists clinical evaluation documents as a mandatory part of the registration dossier. Even where the exemption applies, a set of clinical evaluation documents arguing the applicability of the exemption must still be submitted — not a blank, and not a mere citation of the catalogue entry, but a chapter that demonstrates element by element why the device falls within the exemption and what evidence supports each element.

4. Practical recommendations

• Write the exemption argument as a standalone chapter: argue each of the 4 elements item by item with the sources of evidence attached, as the core content of the clinical evaluation documents.
• Run the safety-history search first: complete the vigilance database and literature search for similar devices before drafting, and produce a written search report.
• Plan the clinical trial early where the evidence is insufficient: do not wait until a supplement is requested; the clinical trial has the longest cycle.
• Prefer the similar-device comparison over a new trial: where the case can be made through the clinical literature, clinical experience or clinical trial data of similar devices, a new trial is unnecessary and the comparison evidence should be organised into the clinical evaluation documents directly.

5. Verification checklist

• □ Whether an exemption is possible has been assessed against the 2 categories of Dispatch No. 5/ISAF/2026
• □ The 4 elements of the first category have been argued in writing item by item
• □ The safety-history search for similar devices (including serious adverse event records) has been completed
• □ Whether non-clinical evidence can independently support safety and effectiveness has been confirmed (second category)
• □ The clinical evaluation documents (including the exemption argument) have been prepared under Article 10(2), item (9)
• □ Where evidence is insufficient, the clinical trial and prior authorisation have been planned early

Regulatory information verified as of 29 October 2026. The regulations, guidelines and effective dates described in this article are limited to the content published by the official sources listed under Legal basis as of that date; where official documents are subsequently updated, the latest published version prevails.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for Macao, China. Our team manages Health Bureau (SSM) pre-market registration and notification applications, prepares reference-approval dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com