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 unable to submit all documents for registration according to the ASEAN Common Submission Dossier Template can submit a subset of essential documents to the FDD. These documents must be accompanied by a letter indicating when the complete set of documents can be provided.
For domestic factories seeking to register medical devices or notify the FDD, a key factor is the risk classification of the medical device, as outlined in Decision 1470. The decision sets out 24 principles for determining the purpose of medical devices in each class, providing a framework for factories to classify their medical devices. However, the FDD retains the authority to reclassify devices if the initial classification by the domestic factory or importer-exporter is deemed inaccurate.
For medical devices that cannot be classified according to the ASEAN harmonized risk classification list for medical devices, the FDD will ascertain the associated risk through its own technical assessment and decision-making process. Medical devices that potentially fall into multiple risk categories will be assigned the highest applicable risk category.
For more details on medical device registration and notification requirements in Laos, please contact Tilleke & Gibbins at [email protected].
