🇲🇴Macau Medical Device Regulations

Medical Device Supervision and Administration Regime

Macau’s new lifecycle framework for medical device registration or filing, clinical investigation, manufacturing, import/export, wholesale, retail, supply, and post-market control.

Implementation Rules for the Medical Device Regime

Implements Law 12/2025 through detailed requirements for registration, filing, business licences, submissions, changes, renewals, and regulatory administration.

Medical Device Classification Rules and Technical Requirements

Defines Macau’s risk-based Classes I, IIa, IIb, and III and the technical requirements used to classify devices under the new regulatory regime.