The Four Stages of Medical Device Registration in Macao, China

1. Key takeaways

Administrative Regulation No. 11/2026 divides medical device registration in Macao, China into 4 stages: pre-procedure consultation → review → inspection → decision. The review stage begins with a formal review completed within 20 working days; once it is passed, the substantive review follows. In the inspection stage, the Pharmaceutical Administration Bureau (ISAF) may conduct development-site inspections and manufacturing-site inspections, and must notify the applicant at least 10 working days before the date of the inspection. In the decision stage, the decision is made by the Director of ISAF, and for innovative devices the opinion of the special committee must first be obtained. Of the 4 stages, the first 2 determine whether the application can be accepted, and the last 2 determine whether it can be approved.

• Registration follows a fixed four-stage sequence, and the order and deliverable of each stage should be mapped before filing.
• The formal review within 20 working days checks only the completeness of the dossier and the standing of the applicant.
• Inspections are discretionary, but once initiated they carry a hard notice period of 10 working days.
• Refusal of registration rests on 3 statutory grounds under Article 16, including false statements or false information in the application.

2. Legal basis

The stages, review, inspection, decision and refusal of registration are governed by the following instruments, verified as of 29 October 2026.

3. Expert insights

Insight 1: the formal review is the gate of acceptance, and the substantive review is the gate of technology. Article 13(1) requires ISAF to complete the formal review within 20 working days from receipt of the application, and the formal review confirms only two things — whether the information is complete and whether the applicant has standing. Article 13(4) then opens the substantive review. The consequences of failing these two gates are identical, namely that the application is not accepted, but their remediability differs: formal deficiencies can be corrected, while a lack of standing cannot be remedied.

Insight 2: inspection is not a mandatory stage, but once triggered it carries hard deadlines. Articles 14(2) and 14(3) provide that ISAF decides whether to conduct a development-site inspection based on the degree of innovation of the device and the past inspection record of the research institution, and whether to conduct a manufacturing-site inspection based on the manufacturing process, the facilities and equipment, and the past inspection record of the manufacturing site. The decision rests with ISAF, and companies should be prepared for the possibility of an inspection.

Insight 3: failure of an inspection leads directly to refusal. Article 14(7) provides that where the applicant fails to correct the deficiencies within the specified period, or where ISAF verifies that the deficiencies remain uncorrected, the inspection is terminated and the registration application is refused. This provision offers no second chance.

Insight 4: refusal of registration has 3 statutory grounds. Under Article 16: non-compliance with the requirements of Article 12; violation of Article 15 (patent-protected medical devices) or Article 18 (protection of data and information); and the provision of false statements or false information in the application process, or the use of other unlawful means. The third category is the most serious one and may give rise to criminal liability.

4. Practical recommendations

• Treat the formal review as a project gate: before submission, check the dossier item by item against the 15-item list in Article 10, because a single missing item can consume the full 20 working days.
• Confirm standing first: applicant eligibility under Article 11 of Law No. 12/2025 cannot be remedied after the fact and must be locked in before submission.
• Keep inspection readiness routine: development records, manufacturing process documents and lists of facilities and equipment should be kept in a state in which they can be produced at any time.
• Start an internal review immediately upon receiving an inspection notice: the notice period is only 10 working days, and the inspection date may be changed upon request.

5. Verification checklist

• □ The sequence and deliverables of the four registration stages have been confirmed
• □ The pre-submission check against the 15-item list of Article 10 has been completed
• □ Applicant standing has been confirmed before submission (a non-remediable item)
• □ Inspection preparation for the development site and the manufacturing site has been completed
• □ The three refusal grounds of Article 16 have been reviewed one by one
• □ The sequencing of the formal review (20 working days) against the subsequent stages has been planned

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