Service Content
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.
Service recipients and application eligibility: Depending on the category of the medical device, the applicant shall meet the relevant legitimacy requirements for the manufacture or import of the corresponding medical device.
Service result: The Pharmaceutical Administration Bureau issues an approval notification to the applicant who submitted the application for approval of the medical device.
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: dmqdbm@isaf.gov.mo