The requirements for Post Market Surveillance in VietNam for medical devices are addressed in Articles 30 to 36 of Decree 36 and Clauses 17 to 22, Article 1 of Decree 169 (VietNamese). The local License Holder is required to keep a device history record with distribution records, record of incidence, etc. Also outlined are required actions and timelines for handling device warnings and adverse events. It can be unclear what events are reportable and so manufacturers should coordinate closely with their VietNam License Holder to ensure compliance and maintain access to the VietNam market.
Contact Asia Actual with questions regarding VietNam Post Market Surveillance. Our local, bi-lingual regulatory experts are well positioned to assist.