Application

---

Approval of Medical Devices Not Subject to the Registration and Listing Regime

How to Apply

Time of application: Medical devices provided for in Article 9(3) of Law No. 12/2025 – Supervision and administration regime for medical devices shall be approved by the Pharmaceutical Administration Bureau before they are manufactured or imported into Macao.

Application eligibility: Depending on the category of the medical device for which approval is sought, the applicant shall meet the corresponding legitimacy requirements relating to manufacture or import.

---

Documents Required

1. A duly completed Specific Application Form for Approval of Medical Devices;
2. The relevant information shall be attached according to the different circumstances:
   1. Medical devices manufactured or imported by order or with approval from the Pharmaceutical Administration Bureau in response to a public health emergency and a shortage of medical devices
      • Explanation and supporting documents showing that the medical device under application meets the relevant circumstances;
      • Samples of the medical device label and instructions for use, if any;
      • Declaration that the applicant assumes responsibility for monitoring adverse events of the medical device;
      • For imported medical devices, proof of marketing shall be provided; if such document is unavailable, the applicant shall submit supporting documents proving the safety and effectiveness of the medical device, including a clinical evaluation report and risk analysis data.
   2. Medical devices solely for research and clinical trials
      • Explanation and supporting documents showing that the medical device under application meets the relevant circumstances;
      • Samples of the medical device label and instructions for use, if any;
      • Declaration that the applicant assumes responsibility for monitoring adverse events of the medical device.
   3. Samples of medical devices used for compiling a registration dossier or listing file
      • Explanation and supporting documents showing that the medical device under application meets the relevant circumstances;
      • Samples of the medical device label and instructions for use, if any;
      • Supporting document proving that the quantity of medical devices to be imported is a reasonable quantity required for the medical device registration or listing procedure.
   4. Medical devices solely for display at academic conferences or exhibitions
      • Explanation stating that the medical device is solely for display at an academic conference or exhibition, together with a declaration that the relevant medical device will not be placed on the market in the Macao SAR;
      • Samples of the medical device label and instructions for use, if any;
      • Supporting document proving that the quantity of medical devices to be imported is a reasonable quantity required for display at the academic conference or exhibition.
   5. Medical devices imported by public departments and entities for the performance of their duties in response to a shortage of medical devices
      • Explanation issued by the public department or entity importing the medical device, specifying that the importation of the medical device is for the performance of its duties;
      • Samples of the medical device label and instructions for use, if any;
      • Declaration that the applicant assumes responsibility for monitoring adverse events of the medical device;
      • For imported medical devices, proof of marketing shall be provided; if such document is unavailable, the applicant shall submit supporting documents proving the safety and effectiveness of the medical device, including a clinical evaluation report and risk analysis data.
   6. Medical devices clinically justified by a qualified practising healthcare professional as necessary for the treatment or diagnosis of the specific condition of a particular patient
      • Explanation stating that the medical device meets the corresponding circumstance of non-application of the registration and listing regime, which shall in particular include:
        • A full explanation by the practising healthcare professional who uses the relevant medical device on the necessity of using the medical device, together with a declaration that the patient has been or will be informed before use that the medical device has not been approved for registration or listing in the Macao SAR, as well as the relevant risks arising from the use of the medical device;
        • Available treatment options for the relevant clinical condition, and the reasons why existing medical devices in the Macao SAR are unsuitable for the relevant patient;
      • The quantity of the medical device required;
      • Declaration that the applicant assumes responsibility for monitoring adverse events of the medical device;
      • For imported medical devices, proof of marketing shall be provided; if such document is unavailable, the applicant shall submit supporting documents proving the safety and effectiveness of the medical device, including a clinical evaluation report and risk analysis data.

---

Remarks/Notes to Application

The Pharmaceutical Administration Bureau may, according to actual needs, require the applicant to submit other information that facilitates the review and approval of the application 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

No fee is required.

---

Relevant Regulations or Requirements

Law No. 12/2025 – Supervision and administration regime for medical devices

Administrative Regulation No. 11/2026 – Implementing Rules for the Supervision and Administration Regime for Medical Devices

Technical Instruction of the Pharmaceutical Administration Bureau No. 14/ISAF/2026 – Preparation and Technical Requirements of Information Required for Applying for Approval of Medical Devices Not Subject to the Registration and Listing Regime

---

Application Status Enquiry and Result Collection

Method of result collection: In person

---