Following harmonization with ASEAN member countries, PFDA opens a faster route to register devices via notification or registration route that has prior approval in any ASEAN member nation. Following the announcement, PFDA will further clarify the provisions of the abridged route. Some of the draft provisions is as follows:
- 1. The abridged route is for the notification and registration of Class B, C, and D medical devices.
- 2. Approval in any ASEAN country must have undertaken full evaluation following AMDD-CSDT requirements. Abridged routes /evaluation in an ASEAN country based on CE certification, US 510(k), and other non-ASEAN regulatory agencies disqualifies the product for the abridged PFDA route.
- 3. The company still needs to submit all legal and technical requirements as stipulated in Administrative Order no. 2018-0002.
This abridged route is effective starting 25 November 2021. Further details and guidelines regarding this announcement will be provided by PFDA.