The Thai FDA has published a Notification clarifying post-market vigilance requirements referenced in sections 5 (1) and 41 (5) of the Medical Device Act B.E. 2551 (2008). The requirements are to go into effect in this November and are considered an important step toward harmonization of the Thai regulations with the ASEAN Medical Device Directive.
The Notification outlines criteria and reporting timelines for device defects or adverse events and field safety corrective actions. In summary, the initial report for adverse events must be submitted within 48 hours, 10 days or 30 days depending on severity with a follow up report 30 days later. This is in line with Singapore and other SE Asian regulations.
Field Safety Corrective Actions must be reported within 48 hours of implementation with a follow up report 21 days later. Significantly, actions that occur within Thailand, as well as globally, must be reported.
Further steps toward harmonization with AMDD are expected in early 2017.