The ASEAN Medical Device Directive (AMDD)  is a regulatory framework established to harmonize the medical device regulations across the ASEAN region. It ensures that medical devices marketed in member countries meet consistent safety, performance, and quality standards. Compliance with the AMDD is crucial for manufacturers and distributors seeking access to ASEAN healthcare markets. What is the ASEAN Medical Device Directive (AMDD)? The AMDD  provides a unified approach for r