How to Apply
Time of application: The medical device registration holder shall submit the renewal application within the period from 180 days to 90 days before the expiry of the validity period of the medical device registration.
Application eligibility: The medical device registration holder may submit the application.
Application methods:
The registration holder may apply through either of the following methods:
- Online application: Log in to “Business & Associations Platform” (path: Services → Departments → Pharmaceutical Administration Bureau → Medical Device Registration and Listing → Registration and Listing Management and Application Enquiry System → Registered Medical Devices → Renewal) to apply for registration renewal.
- In-person application.
Documents Required
- A duly completed Application Form for Renewal of Medical Device Registration;
- Declaration stating that the registration holder still has the legitimacy provided for in Article 11 of Law No. 12/2025, that the relevant medical device still meets the requirements provided for in Article 12 of the same Law, and that the samples of the medical device label and instructions for use, if any, are consistent with the samples approved by the Pharmaceutical Administration Bureau;
- For medical devices manufactured outside the Macao SAR, proof of marketing of the medical device issued by the competent authority or competent body of the place of origin or the country or region where marketing has been approved, except for medical devices manufactured in regions specified by a Chief Executive Dispatch published in the Official Gazette;
- Medical device adverse event monitoring report.
Location of Application and Service Hours
Location of application: Pharmaceutical Administration Bureau – Department of Registration – Division of Chemical Medicines, Biological Medicines and Medical Devices
Address: Avenida do Comendador Ho Yin, Edifício de Escritórios do Governo (Qingmao), 19.º andar, Macau
Service hours:
Mondays to Thursdays: 09:00-13:00; 14:30-17:45
Fridays: 09:00-13:00; 14:30-17:30
Closed on Saturdays, Sundays and public holidays
Fees
MOP220.00, including stamp duty.
Note: In accordance with Article 77(2) of Administrative Regulation No. 11/2026, paid fees will not be refunded if the registration renewal application is not accepted, is rejected, or the application dossier is filed.
Application Processing Time
The medical device registration holder shall submit the renewal application within the period from 180 days to 90 days before the expiry of the validity period of the medical device registration.
Relevant Regulations or Requirements
- 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. 144/2026 – Approves the Table of Fees for Medical Device Business Activities and Registration of Medical Devices
- 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
Application Status Enquiry and Result Collection
Method of result collection:
- Online application: Log in to “Business & Associations Platform” to check the result.
- In-person application: In person.