Frequently asked questions
- Which medical devices require listing?
- Do Class I and Class IIa medical devices require registration?
- Who may proceed with medical device listing?
- What main information is required for a medical device listing application?
- Are medical devices manufactured outside the Macao SAR required to submit proof of marketing?
- How long is medical device listing valid?
- If there are changes to listed information, is it necessary to notify the Pharmaceutical Administration Bureau?
1. Which medical devices require listing?
In accordance with Law No. 12/2025 – Supervision and administration regime for medical devices, Class I and Class IIa medical devices are subject to listing with the Pharmaceutical Administration Bureau. They may only be supplied in accordance with the law after the listing procedure has been completed.
2. Do Class I and Class IIa medical devices require registration?
Class I and Class IIa medical devices are not subject to registration management and shall be listed in accordance with Law No. 12/2025 – Supervision and administration regime for medical devices and its supplementary regulations.
3. Who may proceed with medical device listing?
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 proceed with the listing of Class I and Class IIa medical devices.
4. What main information is required for a medical device listing application?
The applicant shall submit the application form, applicant information, risk analysis data if any, product technical requirements and test reports, labels, instructions for use, packaging information, and other required documents in accordance with the Technical Instructions issued by the Pharmaceutical Administration Bureau.
5. Are medical devices manufactured outside the Macao SAR required to submit proof of marketing?
For medical devices manufactured outside the Macao SAR, the applicant shall submit, as required, a certificate of registration, proof of marketing, or other equivalent supporting document issued by the country or region of origin, except for medical devices manufactured in the Guangdong-Macao In-depth Cooperation Zone in Hengqin.
6. How long is medical device listing valid?
Medical device listing has no validity period. The listing remains valid indefinitely as long as it is not cancelled by the listing holder or cancelled as required by the Pharmaceutical Administration Bureau.
7. If there are changes to listed information, is it necessary to notify the Pharmaceutical Administration Bureau?
If there are changes to the listed information, the listing holder shall notify the changes in accordance with Law No. 12/2025 – Supervision and administration regime for medical devices and the relevant Technical Instructions.