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Macao SAR Government Portal

Medical Devices Registration

Changes of Registration Information

How to Apply

Time of application: Before changing the registered information of a medical device, the medical device registration holder shall notify the Pharmaceutical Administration Bureau of the relevant changes or obtain prior authorization from the Pharmaceutical Administration Bureau.

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 → Changes) to apply for changes to registration.
  • In-person application.

Documents Required

  1. A duly completed Application Form for Changes to Medical Device Registration;
  2. General documents
    • Declaration of conformity made by the registration holder;
    • Statement on the circulation status of the medical device;
    • For medical devices manufactured outside the Macao SAR, if the changes to registered information involve an update to the proof of marketing of the medical device, the registration holder shall submit the updated proof of marketing of the medical device; if the changes to registered information do not involve an update to the proof of marketing of the medical device, the relevant declaration shall be submitted.
    • If the medical device is subject to patent protection, the relevant supporting documents shall be submitted. If the medical device is not subject to patent protection, a declaration shall be submitted.
  3. For changes to registered information of medical devices that are subject to notification to the Pharmaceutical Administration Bureau in accordance with Article 23(1) of Law No. 12/2025 – Supervision and administration regime for medical devices, the registration holder shall attach the following information according to the specific content of the changes:
    1. Explanation of the changes and relevant supporting documents
      • A detailed description of the changes shall be provided, together with the reasons and purposes of the changes;
      • Relevant supporting documents shall be provided according to the specific circumstances of the changes to the registered information of the medical device;
      • In the case of a change of registration holder, the following information shall be attached:
        • Information on the proposed new registration holder referred to in Article 10(2)(1) to (3) of Administrative Regulation No. 11/2026, except where the proposed new registration holder is the holder of a medical device manufacturing license or the holder of a medical device business license for import, export and wholesale activities;
        • Agreement entered into between the registration holder and the proposed new registration holder in relation to the change of registration holder, which shall in particular include a declaration by the proposed new registration holder that it assumes the relevant obligations of the registration holder for medical devices already in circulation;
        • Undertaking by the proposed new registration holder that, after the change, the manufacturer, technical requirements, risk analysis data and other information of the medical device will remain consistent with those before the change.
  4. For changes to registered information of medical devices that require prior authorization from the Pharmaceutical Administration Bureau in accordance with Article 23(2) of Law No. 12/2025 – Supervision and administration regime for medical devices, the registration holder shall, by reference to the “Preparation and Technical Requirements of Information for Applying for Medical Device Registration” approved by Dispatch No. 7/ISAF/2026, attach the required information according to the actual changes, so as to prove that the medical device after the changes still meets the statutory requirements for medical devices, including but not limited to the following information:
    1. Explanation of the changes
      • The proposed changes, reasons and purposes shall be described in detail.
    2. Risk analysis data
      • Risk analysis data relating to the changes to the medical device shall be provided.
    3. Checklist of Essential Principles of Safety and Performance of Medical Devices;
    4. Technical requirements of the medical device
      • Applicable standards: The standards applicable to the medical device shall be listed, together with the compliance status with such standards after the changes, and any changes in applicability and conformity that may arise due to revisions of the standards shall be explained;
      • Technical requirements: If the technical requirements of the medical device need to be changed due to revisions of standards or other changes, the specific content of the changes to the technical requirements of the medical device shall be specified.
    5. Medical device test summary report
      • Documents such as a test summary report and/or certificate of conformity issued by the medical device manufacturer or a third-party testing institution after testing the medical device according to the parts of the technical requirements of the medical device involving the changes shall be submitted.
    6. Clinical evaluation data
      • If the relevant changes may affect the safety and effectiveness of the medical device, the registration holder shall provide relevant clinical evaluation data in accordance with the “Specific Requirements for Clinical Evaluation of Medical Devices” approved by Dispatch No. 2/ISAF/2026.
    7. Non-clinical evaluation data
      • The impact of the relevant changes on the safety and effectiveness of the medical device shall be analysed and explained;
      • According to the actual changes, summaries of non-clinical studies, an overview of the studies conducted and their methods and conclusions, and the relevant study data shall be provided;
      • For medical devices exempted from clinical evaluation, the registration holder shall assess the impact of the relevant changes on the demonstration of equivalence between the medical device and the products listed in the “Catalogue of Medical Devices Exempted from Clinical Evaluation” approved by Dispatch No. 5/ISAF/2026. Where necessary, demonstration shall be made in terms of basic principles, structural composition, safety, effectiveness, scope of application and other aspects in accordance with the requirements of Appendix II to the “Preparation and Technical Requirements of Information for Applying for Medical Device Registration” approved by Dispatch No. 7/ISAF/2026.
    8. Medical device label and instructions for use, if any
      • The content of the changes shall be explained, and the relevant label or instructions for use samples before and after the changes shall be submitted;
      • In other circumstances, the registration holder shall provide the corresponding explanation.
    9. Proof that the medical device manufacturer meets the conditions and requirements necessary for manufacturing medical devices.

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

MOP110.00 per item, including stamp duty.

(Fee is charged per item of information to be changed; for related changes, all involved items are calculated as a single item.)

Note: In accordance with Article 77(2) of Administrative Regulation No. 11/2026, paid fees will not be refunded if the application for changes to registration is not accepted, is rejected, or the application dossier is filed.

Application Processing Time

Notification-type changes: The Pharmaceutical Administration Bureau shall be notified in writing at least 20 working days in advance.

Authorization-type changes: The Pharmaceutical Administration Bureau shall make a decision within a maximum of 100 working days from the date of receipt of the application and all information required for review and approval.

Relevant Regulations or Requirements

Application Status Enquiry and Result Collection

Method of result collection:

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Content provider: Pharmaceutical Administration Bureau (ISAF)

Last modified: 2026-07-04 01:05

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