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Macao SAR Government Portal

Medical Devices Registration

First Application

How to Apply

Time of application: Only Class IIb and Class III medical devices registered 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:

  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 submit an application for medical device registration, 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 filing;
    • 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 submit an application for medical device registration 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:
    • Be the holder of a medical device business license for import, export and wholesale / be a firm for the import, export and wholesale of pharmaceutical products / be the holder of an import, export and wholesale license for Chinese medicines;
    • Must not be subject to an ancillary penalty, ancillary sanction, or security measure that prohibits them from applying for medical device registration or filing.

Documents Required

  1. A duly completed Application Form for Medical Device Registration (click here to use the online application service).
  2. Documents relating to the applicant:
    1. 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 registration application;
  4. Risk analysis data of the medical device;
  5. Checklist of Essential Principles of Safety and Performance of Medical Devices;
  6. Technical requirements of the medical device;
  7. Medical device test summary report issued by the medical device manufacturer or a third-party testing institution;
  8. Clinical evaluation data;
  9. Non-clinical evaluation data;
  10. Samples of the medical device label and instructions for use, if any;
  11. Proof that the medical device manufacturer meets the conditions and requirements necessary for manufacturing medical devices; in the case of contract manufacturing of medical devices, supporting documents relating to such contract manufacturing, in particular the contract manufacturing authorization, draft contract, or copy of the contract;
  12. 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 Hengqin in accordance with Chief Executive Dispatch No. 142/2026;
  13. For innovative medical devices whose main working principle or mechanism of action is original, whose technology is at an internationally leading level, and which have significant clinical application value, an assessment report on the quality, efficacy and safety of the medical device issued by a credible third-party technical review institution listed in the Technical Instruction approved by Dispatch No. 15/ISAF/2026 may be submitted at the time of application, if available;
  14. 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.

Notes:

  1. When submitting a registration application for a Class III medical device manufactured outside the Macao SAR, an authorization letter issued by the manufacturer or an equivalent supporting document must be submitted;
  2. The Pharmaceutical Administration Bureau may, according to the actual needs of the registration 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

MOP550.00, including stamp duty, to be paid in full upon submission of the application.

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

Application Processing Time

Depending on the registration category, a decision on the registration application shall be made within the following periods from the date of receipt of the application and all information required for review and approval:

  • Class IIb medical devices: 70 working days;
  • Class III medical devices: 100 working days;

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:

Service result:

After the registration application is approved, the Pharmaceutical Administration Bureau will issue a Certificate of Registration of Medical Device. The registration of medical devices is valid for five years.

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Content provider: Pharmaceutical Administration Bureau (ISAF)

Last modified: 2026-07-03 23:12

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