Laos Further Clarifies Medical Device Registration

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 device registration scheme, all class C and D medical devices will need to begin product registration on January 1, 2024. All Class A and B devices will need to notify the FDD (Class A) and register class B products by January 1, 2025.

To help facilitate a smooth registration process, Laos companies that import medical devices will need to submit their device applications to the FDD, including device classification and device country of origin by December 15, 2023. Laos importers that do not meet this deadline can still apply for Class C and D registration, but FDD approvals may be delayed. Documents required for registration will follow the ASEAN Common Submission requirements.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.

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