Pharmaceutical Administration Bureau (ISAF), Macao

The Pharmaceutical Administration Bureau of the Macao Special Administrative Region is the authority responsible for pharmaceuticals, medical devices, and related regulated products. It is commonly identified by the Portuguese acronym ISAF, from Instituto para a Supervisão e Administração Farmacêutica. Companies supplying devices in Macao should use the Bureau's dedicated medical device portal and current rules.

What does ISAF do for medical devices?

ISAF administers device filing and registration, regulates relevant operators, publishes technical and administrative requirements, and oversees post-market safety and enforcement. It also provides official searches and online services through Macao's medical device information system.

What changed in Macao's medical device framework?

Macao enacted Law No. 12/2025 and Administrative Regulation No. 11/2026 to establish a dedicated medical device supervision system effective July 1, 2026. The framework formalizes risk classification, product controls, operator responsibilities, registration or filing routes, and lifecycle obligations. Businesses that previously relied on older administrative arrangements should reassess their products and roles under the new system.

How are medical devices classified in Macao?

The system uses Class I, Class IIa, Class IIb, and Class III. Class I represents the lowest risk and Class III the highest. Under the new framework, Class I and IIa devices generally follow filing requirements, while Class IIb and III devices generally require registration. The exact route depends on the classification rules, intended purpose, and any device-specific provisions.

Does a foreign manufacturer need a local party?

Overseas manufacturers should identify a qualified local applicant or responsible economic operator before submission. The local arrangement may affect filings, imports, distribution, authority communications, vigilance, and recalls. Contracts should clearly allocate control of regulatory records and responsibilities for changes, renewals, and termination.

What evidence should manufacturers prepare?

The package may include device and manufacturer information, classification rationale, quality and conformity evidence, proof of prior authorization where relevant, labeling, instructions for use, and safety and performance documentation. Higher-risk devices require more regulatory scrutiny. Applicants should map legacy products to the new classification and submission framework rather than assume continuity.

Where can I find official ISAF information?

Use the Macao Medical Devices Information System for official requirements, searches, announcements, and e-services. ISAF lists pqm@isaf.gov.mo as a medical-device contact channel.

Related Macao regulatory topics

See our Macao medical device registration overview for market-entry details and implementation considerations.