Laos Announces First Ever Medial Device Registration Requirements

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 registration procedures. Laos’ policies basically follow the 2015 Medical Device Directive for ASEAN. Like most countries, medical devices in Laos are defined as articles that diagnose, monitor, or treat diseases. There are 4 classes including Class A as the lowest risk and Class D as the highest risk. All locally made and imported Class B, C, and D devices need FDD registration. Some devices are exempted from registration including Class A products that only need notification, products used for personal use in limited amounts, and refurbished products. Registration certificates are good for 5 years but need to be renewed.

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.