Macau medical device registration timeline

Source-linked clocks

Pharmaceutical Administration Bureau (ISAF) (ISAF) review clocks and end-to-end planning ranges, using the 4-class (I, IIa, IIb, III) — Administrative Regulation 11/2026 classification system.

4 pathways4 of 4 clocks verifiedvalidity 5 yearsMDSAP not acceptedreviewed 2026-08-25

Class / pathway	Review clock	Planning total	With prior approval	Provenance
Class I(Formality review) Administrative Regulation 11/2026: Class I devices file for formality review, completed in 5 working days	5 working days	1-2 months	—	Verified
Class IIa(Formality review) Administrative Regulation 11/2026: Class IIa devices file for formality review, completed in 5 working days	5 working days	1-3 months	—	Verified
Class IIb(Registration) Administrative Regulation 11/2026: Class IIb registration decided within 70 working days; a one-time 45-working-day extension and stop-clock for sponsor responses may apply	70 working days	4-6 months	—	Verified
Class III(Registration) Administrative Regulation 11/2026: Class III registration decided within 100 working days; a one-time 45-working-day extension and stop-clock for sponsor responses may apply	100 working days	6-9 months	—	Verified

Review clocks exclude applicant hold time · planning totals are estimates

Macau Medical Device Registration Process

Step-by-step ISAF registration process. Total estimated timeline: 1-2 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by ISAF. Appoint a Macau Authorized Representative.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to ISAF including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

ISAF reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

5 working days

In-depth technical assessment of device safety and performance. ISAF may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, ISAF issues Macau market authorization certificate.

Summary: The Macau medical device registration process through Pharmaceutical Administration Bureau (ISAF) (ISAF) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

Prior approval recognition

CE Mark (EU MDR)Technical documentation and QMS evidence reuse1-3 months

FDA 510(k)/PMASubmission content reuse as reference evidence

Key requirements

Local Authorized Representative (Macau-registered importer) required for foreign manufacturers
Pre-approval changes decided within 100 working days (+45 extension)
Supplementary documentation windows pause the review clock

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Source-linked review clocks verified against ISAF publications · full review 2026-08-25 · row IDs are stable — cite as registration-timeline:macau:class-i