Medical Devices Registration

Service Introduction

In accordance with the provisions of Law No. 12/2025 – Supervision and administration regime for medical devices, the Pharmaceutical Administration Bureau handles registration applications for Class IIb and Class III medical devices that meet the relevant requirements. Medical devices may only be circulated in the Macao Special Administrative Region after their registration has been approved.

Service recipients: Persons or entities who intend to apply for registration of Class IIb and Class III medical devices, so that such medical devices may be circulated 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.

Eligibility:

In accordance with the provisions of 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 registration:

1. In accordance with paragraph 1 of Article 11 of Law No. 12/2025 – Supervision and administration regime for medical devices, a natural or legal person who meets all of the following requirements and manufactures medical devices in the Macao Special Administrative Region or elsewhere, either by itself or through contract manufacturing, may submit an application for medical device registration:
   • For a natural person, his/her residence is located in the Macao Special Administrative Region; for a legal person, it is lawfully established in the Macao Special Administrative Region;
   • It is not within the period of an accessory penalty, accessory sanction or security measure prohibiting it from engaging in medical device business activities;
   • It is not within the period of an accessory penalty, accessory sanction or security measure prohibiting it from applying for medical device registration or making a filing;
   • It does not have any debt under compulsory collection through tax enforcement proceedings.
2. In accordance with paragraph 2 of Article 11 of Law No. 12/2025 – Supervision and administration regime for medical devices, an applicant who meets all of the following requirements may submit an application for medical device registration for the importation and circulation in the Macao Special Administrative Region of medical devices that have been registered or authorised for sale outside the Macao Special Administrative Region:
   • Holder of a medical device business activity licence for import, export and wholesale activities / licence for firm for import, export and wholesale of pharmaceutical products / holder of a Chinese medicines import, export and wholesale licence;
   • It is not within the period of an accessory penalty, accessory sanction or security measure prohibiting it from applying for medical device registration or making a filing.

Service result: The Pharmaceutical Administration Bureau approves the registration of medical devices that meet the relevant requirements and issues a medical device registration certificate. The validity period of medical device registration is five years.

Enquiry Channels

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

Correspondence address: 19^th Floor, Government (Qingmao) Offices, Avenida do Comendador Ho Yin, Macao

Tel: (853) 2883 1906

Fax: (853) 2883 1905

Email: dmqbdm@isaf.gov.mo