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Macao SAR Government Portal

Medical Devices Listing

Application

How to Apply

Time of application: Only Class I and Class IIa medical devices listed in accordance with Law No. 12/2025 – Supervision and administration regime for medical devices may be placed in circulation in the Macao SAR.

Application eligibility:

In accordance with Law No. 12/2025 – Supervision and administration regime for medical devices, persons or entities that meet the following requirements may submit an application for medical device listing:

  1. In accordance with Article 11(1) of Law No. 12/2025 – Supervision and administration regime for medical devices, natural or legal persons who manufacture medical devices, either themselves or through contract manufacturing, in or outside the Macao SAR, may proceed with medical device listing, provided they cumulatively meet the following requirements:
    • Must have domicile in the Macao SAR, in the case of a natural person, or be legally established in the Macao SAR, in the case of a legal person;
    • Must not be subject to an ancillary penalty, ancillary sanction, or security measure that prohibits them from engaging in medical device business activities;
    • Must not be subject to an ancillary penalty, ancillary sanction, or security measure that prohibits them from applying for medical device registration or listing;
    • Must have no debts subject to compulsory collection through tax enforcement proceedings.
  2. In accordance with Article 11(2) of Law No. 12/2025 – Supervision and administration regime for medical devices, an applicant who cumulatively meets the following requirements may proceed with medical device listing for the purpose of importing medical devices that have been registered or granted marketing authorization outside the Macao SAR for circulation in the Macao SAR:
    • Foreign trade operator;
    • Must not be subject to an ancillary penalty, ancillary sanction, or security measure that prohibits them from applying for medical device registration or listing.

Documents Required

  1. A duly completed Application Form for Medical Device Listing (click here to use the online application service).
  2. Documents relating to the applicant;
    1. If the applicant is a legal person:
      • Original commercial registration certificate issued by the Commercial and Movable Property Registry (exempted if the company has already been registered with the Commercial and Movable Property Registry);
      • Copies of identification documents of managers and members of the administrative bodies;
      • Original criminal record certificate of managers and members of the administrative bodies (purpose of application: application related to the registration or listing of medical devices; the application may be submitted to the Identification Services Bureau, through self-service kiosks, or via the Bureau’s website, and the certificate will be sent directly by the Bureau to the Pharmaceutical Administration Bureau);
      • Supporting document issued by the Financial Services Bureau proving that the applicant (legal person) has no debts subject to compulsory collection through tax enforcement proceedings.
    2. If the applicant is a natural person:
      • Copy of identification document;
      • Copy of proof of address;
      • Original criminal record certificate (purpose of application: application related to the registration or listing of medical devices; the application may be submitted to the Identification Services Bureau, through self-service kiosks, or via the Bureau’s website, and the certificate will be sent directly by the Bureau to the Pharmaceutical Administration Bureau);
      • Supporting document issued by the Financial Services Bureau proving that the applicant has no debts subject to compulsory collection through tax enforcement proceedings.
  3. Declaration or supporting document of the legitimacy to submit the listing application;
  4. Technical requirements of the medical device;
  5. Samples of the medical device label and instructions for use, if any;
  6. 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;
  7. If the medical device is subject to patent protection, the relevant supporting document shall be submitted; if the medical device is not subject to patent protection, the relevant declaration shall be submitted.

Remarks/Notes to Application

Class IIa medical devices shall submit risk analysis data of the medical device.

The Pharmaceutical Administration Bureau may, according to the actual needs of the listing review, require the applicant to submit other information regarding the quality, efficacy and safety of the medical device within a specified period.

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

A formal review of the information submitted by the applicant shall be conducted within five working days from the date of receipt of the application, and the notification of completion of the listing procedure shall be issued on the working day immediately following completion of the formal review.

Relevant Regulations or Requirements

Application Status Enquiry and Result Collection

Application status enquiry:

  • Online application: Log in to “Business & Associations Platform” to check the application status.
  • In-person application: Call the department to enquire about the real-time application status.

Method of result collection:

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Content provider: Pharmaceutical Administration Bureau (ISAF)

Last modified: 2026-07-06 19:11

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