December 6, 2023
New regulatory requirements for medical device registration and notification in Laos are set to enter into force in the coming weeks under the plan found in Notification No. 9606 to implement Decision No. 1470/MOH on Registration and Notification of Medical Devices (Decision 1470). The notification, issued on October 25, 2023, by the Food and Drug Department (FDD) under the Ministry of Health (MOH), outlines the FDD’s strategic plan for phased-in registration and notification requirements for medical devices. In the first phase, starting January 1, 2024, the FDD will initiate the registration process for class C (moderate-high risk) and D (high risk) medical devices. Meanwhile, operators dealing with class A (low risk) and B (low-moderate risk) devices can continue applying for import permits without having to register the devices or notify the FDD. In the subsequent phase, starting January 1, 2025, operators will have to notify the FDD about class A devices and complete the registration process for class B devices. To prepare for these requirements, import-export companies in the pharmaceutical and medical products sector must submit a list of medical devices, including their classification based on the country of manufacture, to the FDD by December 15, 2023. This measure is aimed at enabling the FDD to streamline the collection, guidance, and preparation processes to ensure efficient registration within the set time frame. While import-export companies can still submit their lists after either December 15, 2023, or January 1, 2024 (the registration commencement date), registration may be delayed since the FDD will prioritize those who submit their lists by the December 15 deadline. The list of medical devices should encompass medical devices imported in the past as well as those intended for future import permission applications. During the initial registration stage (i.e., from January 1, 2024), import-export companies that are