Snapshot

The Macao SAR Fast-Track / Urgent-Use Entry via the Greater Bay Area (GBA) Medicine and Equipment Connect pathway has been developed by the of Macao.

This pathway can be used where General Medical Devices (Classes I–III): - Listing: Mandated for Class I (low risk) and Class IIa (medium-low risk) products & requires proof of manufacturer legal standing, labeling compliance, and country-of-origin approval. Validity is indefinite unless revoked. - Registration: Mandated for Class IIb (medium-high risk) and Class III (high risk, e.g., implants, active therapeutic devices) & requires full dossier evaluation by the Committee of Experts and Advisors, technical audits, and pre-procedural consultation. Approvals issue a 5-year renewable certificate. In Vitro Diagnostics (IVDs): Reagents, test kits, and calibrators are categorized by systemic risk. Low-risk analyzers follow Listing; high-risk screening kits, genetic diagnostics, and companion diagnostics require full Registration. (Specific manufacturing oversight is governed by Technical Instruction No. 20/ISAF/2026) Combination Products: Medical devices containing integral secondary medicinal substances (e.x., drug-eluting stents) are evaluated under Law No. 12/2025 via joint technical reviews between ISAF's medical device and pharmaceutical divisions. Prerequisites & Distribution Rules: - Country-of-Origin Proof: Foreign-manufactured devices require prior authorization from their jurisdiction of origin or a recognized reference authority, except for designated regional manufacturing exemptions. - Channel Control: Class III devices cannot be sold in retail outlets. Import and distribution are restricted to licensed wholesalers that supply authorized healthcare institutions. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Australia Canada China Europe Japan United Kingdom United States

Target time assessment is Target Time: ~98–140 Calendar Days ( around 70–100 working days) - Class IIb Devices: 70 working days (~98 calendar days) - Class III Devices: 100 working days (~140 calendar days) .