Recently, The Asia Pacific Medical Technology Association (APACMed) released their position paper titled “Risk-based Change Management for Registered Medical Devices.” As noted in this paper, some Asian countries utilize risk-based methods for device changes, while others require change submissions no matter what... Read More
As mentioned in our September newsletter, Laos’ Food and Drug Department (FDD) put into practice its Registration and Notification of Medical Devices (Decision 1470) in October 2023. Laos follows the ASEAN harmonized risk classification list for medical devices. According to their new... Read More
On September 9, Laos will implement its first-ever medical device regulations. While in 2011, a registration policy was discussed, medical device registration was not implemented. Laos’ Ministry of Health Food and Drug Department (FDD) has outlined the required registration documents and specific... Read More