ASEAN Medical Device Registration Guidelines

SUBJECT: Guidelines Governing the Issuance of an Authorization for a Medical Device based on

the ASEAN Harmonized TechnicalRequirements I. RATIONALE The fast evolution

of medical technology and the essential role of medical devices in the health care

delivery system have highlighted the importance of ensuring the safety and effectiveness

of these devices through regulation while facilitating trade among the ten member states

of the Association of Southeast Asian Nations (ASEAN). Structured and regionally accepted

technical requirements were developed through the ASEAN Consultative Committee on Standards and

Quality — Medical Device Product Working Group (ACCSQ-MDPWG). The development of the common submission