Priority Review and Conditional Approval Pathways for Medical Devices

1. Key takeaways

The Macao regime provides 2 accelerated and flexible channels for special situations: Dispatch No. 8/ISAF/2026 on the specific requirements for applying for priority review of medical device registration, and Dispatch No. 9/ISAF/2026 on the specific requirements for applying for conditional approval of medical device registration. The former addresses speed, while the latter addresses situations where the evidence is not yet complete but the clinical need is pressing. Both channels require an active application, and each has a price: priority review requires meeting the eligibility conditions set out in the dispatch, while conditional approval means approval with conditions, and failure to fulfil the conditions constitutes a risk.

• Priority review solves a timing problem; conditional approval solves an evidence problem, and the two must not be conflated.
• Conditional approval interacts with the registration holder obligations of Article 16 of Law No. 12/2025.
• Both dispatches overlap with, but are distinct from, the innovative medical device pathway under Dispatch No. 15/ISAF/2026.
• Acceleration does not change the suspension rules: a deficiency correction still suspends the period.
• The eligibility judgements for both channels leave room for regulatory discretion, so the pre-procedure consultation should be used to confirm the applicable interpretation before submitting.

2. Legal basis

The priority review and conditional approval channels are governed by the following instruments, verified as of 29 October 2026.

3. Expert insights

Insight 1: the two channels solve different problems and must not be used interchangeably. Priority review targets time — the product already has a complete dossier on the basis of existing evidence, and the applicant merely wishes to shorten the queue; conditional approval targets evidence — the dossier is incomplete but the clinical value is significant, and approval is allowed in advance subject to the fulfilment of conditions. Treating conditional approval as a shortcut when the dossier is incomplete is a misuse of the channel and, once the conditions attached to it are not fulfilled, becomes a compliance risk in its own right.

Insight 2: conditional approval stacks on top of the Article 16 obligations. Article 16 of Law No. 12/2025 sets out the obligations of the registration holder (ensuring compliance with quality standards, maintaining the quality management system, formulating post-market study and risk control plans, adverse event monitoring and post-market evaluation, product traceability and recall, and allocating resources). After conditional approval, these obligations become the vehicle for fulfilling the conditions — post-market studies and risk control plans above all, since the evidence gap that justified the conditional approval is precisely what those studies and plans are expected to close within the agreed timetable.

Insight 3: the two dispatches overlap with, but are not identical to, the innovative medical device channel. The technical instruction for the innovative device channel is Dispatch No. 15/ISAF/2026 (the list of third-party technical review bodies); priority review and conditional approval are two separate channels. A product may qualify for both the innovative device channel and priority review, and the applications should be filed separately.

Insight 4: acceleration does not change the suspension rules. The suspension clause of Article 17(3) applies equally to priority review — a deficiency correction still suspends the period. What priority review shortens is the queuing and review time; it does not waive document quality, and any request for further information or notice of correction will still suspend the running of the approval period until the applicant has responded.

4. Practical recommendations

• Run an eligibility self-assessment first: confirm eligibility item by item against Dispatches No. 8 and No. 9/ISAF/2026; applying without eligibility wastes the window.
• Run priority review in parallel with a complete dossier: acceleration presupposes a complete dossier; filing for acceleration while still fixing the dossier puts the cart before the horse.
• Design the condition-fulfilment plan before applying for conditional approval: write the timetable for post-market studies, risk controls and supplementary evidence into the plan, and execute it immediately upon approval.
• Assess the three channels separately: judge the innovative device channel, priority review and conditional approval according to product characteristics, and file together those parts that can be combined.
• Confirm the applicable interpretation through the pre-procedure consultation: the eligibility judgement for accelerated channels leaves room for discretion; consult first, then submit.

5. Verification checklist

• □ Eligibility for priority review has been confirmed against Dispatch No. 8/ISAF/2026
• □ Eligibility for conditional approval has been confirmed against Dispatch No. 9/ISAF/2026
• □ The timing problem and the evidence problem have been distinguished, and the corresponding channel selected
• □ The condition-fulfilment plan for conditional approval has been prepared in advance
• □ Combined application with the innovative device channel (Dispatch No. 15/ISAF/2026) has been assessed
• □ The eligibility judgement has been confirmed through the pre-procedure consultation

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