Prior Authorisation for Medical Device Clinical Trials in Macao, China

1. Key takeaways

To conduct a medical device clinical trial in the Macao Special Administrative Region of China, prior authorisation from ISAF must be obtained in advance. Two instruments govern the field: Dispatch No. 3/ISAF/2026 on the Good Clinical Practice (GCP) for medical device clinical trials, and Dispatch No. 4/ISAF/2026 on the document preparation and technical requirements for applying for prior authorisation of medical device clinical trials. The former governs how the trial is conducted, and the latter governs what the application must contain. In addition, Article 9(3), item (2) of Law No. 12/2025 lists medical devices for research use and clinical trials only as a situation to which the registration and notification regime does not apply — trial-use devices go through the prior authorisation channel, not the registration channel.

• Prior authorisation and the exemption from registration are two sides of the same coin: exempt from registration, not from approval.
• GCP and prior authorisation requirements are separated into two dispatches, governing process compliance and access compliance respectively.
• For innovative devices, the opinion of ISAF on the protocol can be obtained even earlier, at the critical-stage consultation.
• Whether a clinical trial must be conducted in Macao, China depends on the strength of existing evidence, not on the risk class.
• The trial-use device itself must still be submitted for approval under Article 26 of the Implementing Rules, using the dedicated forms and explanatory documents.

2. Legal basis

Prior authorisation for clinical trials, the applicable GCP and the exemption of trial-use devices from registration are governed by the following instruments, verified as of 29 October 2026.

3. Expert insights

Insight 1: prior authorisation and the exemption are two sides of the same coin. Article 9(3), item (2) of Law No. 12/2025 excludes clinical-trial-use devices from registration and notification, while Article 26 of the Implementing Rules sets an approval procedure for such devices. In other words, exemption from registration does not mean exemption from approval — prior authorisation for the clinical trial must be obtained first.

Insight 2: GCP and prior authorisation are set out in two separate dispatches, showing that process compliance and access compliance are managed apart. GCP governs the entire course of trial conduct (subject protection, data reliability, adverse event reporting and the like), while the prior authorisation requirements govern the application stage. Companies should schedule these two lines separately in their project plans, because a project that meets the GCP obligations but arrives at ISAF with an incomplete authorisation dossier will still be delayed at the access step.

Insight 3: for innovative devices, the opinion of ISAF on the protocol can be obtained before this point. Article 12(2) provides that, at a critical stage of a clinical trial for an innovative device, ISAF may, upon request, express an opinion or provide suggestions on the next research protocol. This is an earlier and cheaper communication opportunity than a formal prior authorisation application, suitable for settling primary endpoints and sample size.

Insight 4: how overseas clinical data are handled is the key practical question. The Macao regime allows clinical evaluation to be conducted using the clinical literature, clinical experience and clinical trial data of similar devices (the subject of the companion article), and a clinical trial is needed only where the existing evidence is insufficient. Whether a clinical trial must be conducted in Macao, China therefore depends on the strength of the existing evidence, not on the risk class, and the evidence position should be documented before the trial decision is made.

4. Practical recommendations

• Assess first whether the clinical trial can be waived: for the vast majority of conventional products, the similar-device comparison or exemption-list route should be preferred, avoiding the clinical trial procedure.
• Where a trial in Macao, China is required, start with the pre-procedure consultation: for innovative devices, the opinion of ISAF on the research protocol can be obtained at the critical stage.
• Build the GCP system early: trial sites, ethics, informed consent, data management and adverse event reporting procedures must comply with Dispatch No. 3/ISAF/2026.
• File the approval application for non-registration situations in parallel: submit the dedicated forms and explanatory documents under Article 26 of the Implementing Rules.

5. Verification checklist

• □ Whether the clinical trial can be waived through the exemption list or similar-device comparison has been assessed
• □ Where a trial is required, whether it will be conducted within Macao, China has been confirmed
• □ For trials conducted locally, the application for prior authorisation (Dispatch No. 4/ISAF/2026) has been planned
• □ The GCP system has been established in accordance with Dispatch No. 3/ISAF/2026
• □ Trial-use devices have been submitted for approval under Article 26 of the Implementing Rules
• □ For innovative devices, the critical-stage consultation has been used to obtain the opinion on the protocol

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