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Macao SAR Government Portal

Medical Devices Listing

Changes of Listing Information

How to Apply

Time of application: The medical device listing holder shall notify the Pharmaceutical Administration Bureau before implementing the relevant changes to the information of the medical device in the Macao SAR.

Application eligibility: The medical device listing holder may submit the application.

Documents Required

  1. A duly completed Application Form for Changes to Listed Information of Medical Devices   (click here to use the online application service);
  2. General documents
    • Declaration of conformity made by the listing holder;
    • Statement on the circulation status of the medical device;
  3. According to the specific content of the changes, the listing holder shall also attach the following information:
    1. Change of listing holder
      • Information on the proposed new listing holder referred to in Article 21(2)(1) to (3) of Administrative Regulation No. 11/2026, except where the proposed new listing holder is the holder of a medical device manufacturing license or a foreign trade operator;
      • Agreement entered into between the listing holder and the proposed new listing holder in relation to the change of listing holder, which shall in particular include a declaration by the proposed new listing holder that it assumes the relevant obligations of the listing holder for medical devices already in circulation;
      • Undertaking by the proposed new listing 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.
    2. Change of model or specification information
      • If a model or specification of the medical device is added, the corresponding explanation shall be provided;
      • If only the model code is changed or a listed model or specification of the medical device is removed, the corresponding explanation shall be provided;
      • 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. Change of technical requirements
      • Explanation of the changes to the technical requirements of the medical device, the specific content of which shall refer to the requirements of point 3 of the “Preparation and Technical Requirements of Information for Applying for Medical Device Listing” approved by Dispatch No. 12/ISAF/2026;
      • 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.
    4. Change of label or instructions for use samples
      • Explanation of the changes to the label and instructions for use samples, with the corresponding changes clearly indicated;
      • Declaration made by the listing holder stating that, except for the changes referred to in this notification, the other contents of the label and instructions for use, if any, remain unchanged.
    5. Changes made to improve the medical device based on the results of post-market evaluation
      • Post-market evaluation report of the medical device;
      • For Class IIa medical devices, risk analysis data of the medical device related to the changes shall be submitted;
      • According to the specific changes to the medical device, the corresponding explanation of the changes shall be submitted, the specific content of which shall refer to the requirements of point 3 of the “Preparation and Technical Requirements of Information for Applying for Medical Device Listing” approved by Dispatch No. 12/ISAF/2026;
      • 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.

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

Free of charge

Processing Time

The listing holder shall notify the Pharmaceutical Administration Bureau in writing at least five working days in advance. The Pharmaceutical Administration Bureau will conduct a formal review of the information submitted by the applicant within five working days from the date of receipt of the application, and the notification of completion of the procedure for changes to listed information shall be issued on the working day immediately following completion of the formal review.

Relevant Regulations or Requirements

Result Collection

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Content provider: Pharmaceutical Administration Bureau (ISAF)

Last modified: 2026-07-06 19:12

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