The FDA hosted a meeting on September 19th in Manila at which a revised implementation strategy for the new medical device regulations (Administrative Order 2018-0002) was rolled out. Significant changes were made to the original implementation plan announced back on February 22 to simplify and streamline transition to the new Rules.
- Notified medical devices will be re-classified according to AMDD risk classification
- Validity of initial CMDN & CMDR will be 5 years
- A single application for a medical device system, family or multiple manufacturing sites is allowed (manual submission only), but will generate multiple CMDR/N
- Government processing fee for initial CMDN/CMDR application is PhP7,500 (about US$150)
- All Medical Devices and IVD that are not included in the scope of initial implementation shall be considered non-regulated products; importers License to Operate (LTO) may be provided for customs clearance in lieu of a COE.
- Technical data requirements are as per ASEAN MDD Common Submission Dossier Template (CSDT)
- Administrative data requirements include:
- Letter of authorization copy with Notarized Declaration Letter of Authenticity
- ISO 13485 copy with Notarized Declaration Letter of Authenticity
- Requirement for Certificate of Free Sales (CFS) has been eliminated
- Copy of registration in country of origin with Notarized Declaration Letter of Authenticity
- Color picture of the device from all sides
The FDA will release written guidelines to make these changes official.
Asia Actual has a strong regulatory team in Manila to help device manufacturers stay informed and compliant with regulatory changes. Please contact us with questions or support requests.