Frequently asked questions
- Which medical devices are subject to registration?
- Are Class I and Class IIa medical devices subject to registration?
- Who may submit an application for medical device registration?
- What main information is required for an application for medical device registration?
- Is marketing certification required for medical devices manufactured outside Macao?
- Is a manufacturer’s authorisation document required for registration applications for Class III medical devices?
- How long is the validity period of medical device registration?
- If there is any change to the registration information, is it necessary to notify the Pharmaceutical Administration Bureau?
1. Which medical devices are subject to registration?
In accordance with the provisions of Law No. 12/2025 – Supervision and administration regime for medical devices, Class IIb and Class III medical devices are subject to registration with the Pharmaceutical Administration Bureau. They may only be supplied in accordance with the law after their registration has been approved.
2. Are Class I and Class IIa medical devices subject to registration?
Class I and Class IIa medical devices are not subject to registration management and shall be filed in accordance with the provisions of Law No. 12/2025 – Supervision and administration regime for medical devices and its supplementary regulations.
3. Who may submit an application for medical device registration?
Persons or entities that have the legitimacy to apply as provided for in Law No. 12/2025 – Supervision and administration regime for medical devices may submit an application for registration of Class IIb and Class III medical devices.
4. What main information is required for an application for medical device registration?
The applicant shall submit, in accordance with the technical instructions issued by the Pharmaceutical Administration Bureau, the application form, medical device information, classification description, checklist of the essential principles of safety and performance, risk analysis information, clinical evaluation information, non-clinical information, product technical requirements and inspection report, label, instructions for use, packaging information, and other required documents.
5. Is marketing certification required for medical devices manufactured outside Macao?
For medical devices manufactured outside the Macao Special Administrative Region, the applicant shall submit, as required, the registration certificate, marketing certificate or other equivalent supporting documents issued by the country or region of origin, except for medical devices manufactured in the Guangdong-Macao In-depth Cooperation Zone in Hengqin.
6. Is a manufacturer’s authorisation document required for registration applications for Class III medical devices?
For Class III medical devices, the applicant shall submit, as required, an authorisation letter issued by the manufacturer or other documents proving that the applicant is authorised to handle the relevant registration application.
7. How long is the validity period of medical device registration?
The validity period of medical device registration is five years. If the registration holder intends to continue maintaining the registration, a renewal application shall be submitted in accordance with the relevant requirements before the expiry of the validity period.
8. If there is any change to the registration information, is it necessary to notify the Pharmaceutical Administration Bureau?
If there is any change to the registration information, the registration holder shall handle the notification of change or application for change in accordance with the provisions of Law No. 12/2025 – Supervision and administration regime for medical devices and the relevant technical instructions. For changes subject to prior authorisation, the change may only be made after approval by the Pharmaceutical Administration Bureau.