Macao

1. Authorities

Macau Regulatory Authorities: Home Page - Drug Administration (isaf.gov.mo)

2. Relevant Regulations

Medical device manufacturers enter the Macau market by applying for a prior license for product import (that is, the registration process we mentioned is for applying for this prior license). There are two aspects to the two import licenses for medical devices:

PS-1570 Import of Goods (Drug Supervision and Administration Bureau) – Application for Import Permit – Macao SAR Government Portal (www.gov.mo)

PS-1570 Import of Goods (Drug Supervision and Administration Bureau) – Application for prior authorization for import of medical and health products – Macao SAR Government Portal (www.gov.mo)

3. Time estimation

The average processing time is 4-8 weeks. If a re-application or sample does not meet the requirements, the review time will be postponed depending on the product risk and actual situation.

4. Local Representatives

The pre-approval application for the product requires a local authorized representative in Macau to apply for and manage the license, so a local authorized representative is required. The main responsibility of the local authorized representative is to complete the manufacturer's application process and communicate with the authorities in a timely manner to ensure that the information between the manufacturer and the authorities can be synchronized in a timely manner.

5. Successful Cases

More than 20+ customers successfully registered