Medical Devices Listing

Service Introduction

In accordance with Law No. 12/2025 – Supervision and administration regime for medical devices, the Pharmaceutical Administration Bureau handles the listing of Class I and Class IIa medical devices that meet the relevant requirements. Only Class I and Class IIa medical devices listed in accordance with the Law may be placed in circulation in the Macao Special Administrative Region.

Service recipients: Persons or entities who intend to apply for listing of Class I and Class IIa medical devices, so that such medical devices may be placed in circulation in the Macao Special Administrative Region in accordance with the law, and who have the legitimacy to apply as provided for in Law No. 12/2025 – Supervision and administration regime for medical devices.

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 Special Administrative Region, may proceed with medical device listing, provided they cumulatively meet the following requirements:
   • Must have domicile in the Macao Special Administrative Region, in the case of a natural person, or be legally established in the Macao Special Administrative Region, 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 Special Administrative Region for circulation in the Macao Special Administrative Region:
   • 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.

Service result: The Pharmaceutical Administration Bureau issues a notification of completion of the listing procedure to the applicant who submitted the medical device listing application.

Enquiry Channels

Executing department and unit: Pharmaceutical Administration Bureau – Department of Registration – Division of Chemical Medicines, Biological Medicines and Medical Devices

Correspondence address: Avenida do Comendador Ho Yin, Edifício de Escritórios do Governo (Qingmao), 19.º andar, Macau

Tel: (853) 2883 1906

Fax: (853) 2883 1905

Email: dmqbdm@isaf.gov.mo