Prior Authorization for Clinical Trial

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How to Apply

Time of application: Prior authorization from the Pharmaceutical Administration Bureau must be obtained before conducting clinical trials of medical devices in the Macao SAR.

Application eligibility:

1. Applicant:
   • Must have domicile in the Macao SAR, in the case of a natural person;
   • Must be legally established in the Macao SAR, in the case of a legal person, association or foundation.
2. The institution conducting the clinical trial must comply with the requirements of the Technical Instruction of the Pharmaceutical Administration Bureau No. 3/ISAF/2026 “Good Clinical Practice for Medical Device Clinical Trials (GCP)”.

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Documents Required

1. A duly completed Application Form for Prior Authorization to Conduct Clinical Trials;
2. Documents relating to the applicant:
   1. Natural person
      • Copies of identification document and proof of address;
   2. Company
      • Commercial registration certificate issued by the Commercial and Movable Property Registry;
      • Copies of identification documents of managers and members of the administrative bodies;
   3. Association or foundation
      • Certificate of registration with the Identification Services Bureau and certificate of the leadership structure issued by the Identification Services Bureau;
      • Copies of identification documents of the principal office holders of the bodies;
3. Declaration or supporting document proving the applicant’s legitimacy to submit the application;
4. Supporting document proving that the clinical trial institution complies with Good Clinical Practice or equivalent standards;
5. Supporting document proving that the manufacturing process of the medical device involved in the clinical trial complies with Good Manufacturing Practice or equivalent standards;
6. Study background document of the medical device involved in the clinical trial;
7. General documents, risk analysis, and non-clinical study data of the medical device involved in the clinical trial;
8. Samples of the label and instructions for use, if any, of the medical device involved in the clinical trial;
9. Clinical trial protocol;
10. Investigator’s Brochure;
11. Statistical Analysis Plan;
12. Informed consent form template for trial subjects;
13. Documents relating to the composition and operation of the Ethics Committee of the clinical trial institution.

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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

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Fees

No fee is required.

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Application Processing Time

The medical device clinical trial must be reviewed and approved by the Life Sciences Ethics Committee. Upon receipt of the notification from the Committee, the Pharmaceutical Administration Bureau will issue the prior authorization for the clinical trial to the applicant.

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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. 3/ISAF/2026 – Good Clinical Practice for Medical Device Clinical Trials (GCP)

Technical Instruction of the Pharmaceutical Administration Bureau No. 4/ISAF/2026 – Preparation and Technical Requirements of Information for Applying for Prior Authorization to Conduct Medical Device Clinical Trials

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Result Collection

Method of result collection: In person

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