ASEAN AMDD Harmonisation — Class A/B/C/D Classification Framework
As part of the ASEAN harmonisation initiative under the ASEAN Medical Device Directive (AMDD), the Philippines classifies medical devices using a four-tier risk-based system (Class A, B, C, D) aligned with Brunei, Indonesia, Malaysia, Singapore, Thailand, and Vietnam. The AMDD framework harmonises classification rules, essential principles for safety and performance, and conformity assessment approaches across the region.
The Philippines-specific implementation through CDRRHR maps AMDD classes to local registration and notification pathways:
- Class A → CMDN (notification)
- Class B, C, D → CMDR (full registration)
🔖 Status: in-force
Manufacturers supplying devices to multiple ASEAN markets benefit from the harmonised technical documentation approach — a single set of AMDD-compliant technical files can underpin submissions in multiple ASEAN jurisdictions, subject to local labelling and language adaptations. Review the ASEAN CSDT (Common Submission Dossier Template) to structure your technical documentation for maximum portability.
View official source (CDRRHR Registration) ↗