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Macao SAR Government Portal

Medical Devices Registration

Related legislations

Law No. 12/2025 - Supervision and administration regime for medical devices
Administrative Regulation No. 11/2026 - Implementing Rules for the Supervision and Administration Regime for Medical Devices
Chief Executive Dispatch No. 141/2026 - Sets the amount referred to in Article 8(1) of Law No. 12/2025 “Supervision and administration regime for medical devices”
Chief Executive Dispatch No. 142/2026 - Sets the regions referred to in Article 9(2) of Law No. 12/2025 “Supervision and administration regime for medical devices”
Chief Executive Dispatch No. 143/2026 - Approves the models of licenses for medical device business activities and certificates of registration of medical devices
Chief Executive Dispatch No. 144/2026 - Approves the Table of Fees for Medical Device Business Activities and Registration of Medical Devices
Dispatch of the Secretary for Social Affairs and Culture No. 36/2026 - Approves the “Medical Device Classification Catalogue of the Macao Special Administrative Region”
Technical Instruction of the Pharmaceutical Administration Bureau No. 1/ISAF/2026 - Classification Rules and Technical Requirements for Medical Devices
Technical Instruction of the Pharmaceutical Administration Bureau No. 2/ISAF/2026 - Specific Requirements for Clinical Evaluation of Medical Devices
Technical Instruction of the Pharmaceutical Administration Bureau No. 3/ISAF/2026 - Good Clinical Practice for Medical Device Clinical Trials (GCP)
Technical Instruction of the Pharmaceutical Administration Bureau No. 4/ISAF/2026 - Preparation and Technical Requirements of Information for Applying for Prior Authorization to Conduct Medical Device Clinical Trials
Technical Instruction of the Pharmaceutical Administration Bureau No. 5/ISAF/2026 - Catalogue of Medical Devices Exempted from Clinical Evaluation
Technical Instruction of the Pharmaceutical Administration Bureau No. 6/ISAF/2026 - Naming Rules for Generic Names of Medical Devices, and Technical Requirements for Medical Device Labels and Instructions for Use
Technical Instruction of the Pharmaceutical Administration Bureau No. 7/ISAF/2026 - Preparation and Technical Requirements of Information for Applying for Medical Device Registration
Technical Instruction of the Pharmaceutical Administration Bureau No. 8/ISAF/2026 - Specific Requirements for Applying for Priority Review and Approval of Medical Device Registration
Technical Instruction of the Pharmaceutical Administration Bureau No. 9/ISAF/2026 - Specific Requirements for Applying for Conditional Approval of Medical Device Registration
Technical Instruction of the Pharmaceutical Administration Bureau No. 10/ISAF/2026 - Preparation and Technical Requirements of Information for Applying for Renewal of Medical Device Registration
Technical Instruction of the Pharmaceutical Administration Bureau No. 11/ISAF/2026 - Preparation and Technical Requirements for Notification of and Application for Changes to Registered Information of Medical Devices
Technical Instruction of the Pharmaceutical Administration Bureau No. 15/ISAF/2026 - List of Credible Third-party Technical Review Institutions
Technical Instruction of the Pharmaceutical Administration Bureau No. 16/ISAF/2026 - Good Manufacturing Practice for Medical Devices (GMP)
Technical Instruction of the Pharmaceutical Administration Bureau No. 17/ISAF/2026 - Good Manufacturing Practice for Custom-made Dentures
Technical Instruction of the Pharmaceutical Administration Bureau No. 18/ISAF/2026 - Good Manufacturing Practice for Sterile Medical Devices
Technical Instruction of the Pharmaceutical Administration Bureau No. 19/ISAF/2026 - Good Manufacturing Practice for Implantable Medical Devices
Technical Instruction of the Pharmaceutical Administration Bureau No. 20/ISAF/2026 - Good Manufacturing Practice for In Vitro Diagnostic Reagents
Technical Instruction of the Pharmaceutical Administration Bureau No. 21/ISAF/2026 - Good Manufacturing Practice for Standalone Medical Device Software
Technical Instruction of the Pharmaceutical Administration Bureau No. 22/ISAF/2026 - Preparation and Technical Requirements for Quality Management System Documents for Medical Device Manufacturing Activities
Technical Instruction of the Pharmaceutical Administration Bureau No. 23/ISAF/2026 - Technical Requirements and Specific Rules for Applying for Authorization for Contract Manufacturing of Medical Devices

All information on this site is based on the official language of the Macao Special Administrative Region. The English version is the translation from the Chinese originals and is provided for reference only. If you find that some of the contents do not have an English version, please refer to the Traditional Chinese or Portuguese versions.