New Decree #98 Simplifies Registration Of Medical Devices In Vietnam

Moving to streamline requirements for the approval, licensing, and management of medical devices, Vietnam is now requiring all classes of the devices to be registered with government regulatory authorities. But under a new law that goes into effect January 1, device registration numbers for all devices, with the exception of those granted emergency use authorization, will be valid indefinitely.

The new law puts in place a simplified registration procedure for Class B devices, similar to that already in place for Class A devices. Safety risks for those classes of devices are considered low.

For higher-risk Class C and D devices, the new law sets out an abbreviated registration track for products already approved for sale by one of the specified health regulators including the U.S., Australia, Japan, Canada, the United Kingdom, Switzerland, China, and Korea, among others.

Vietnam has reduced the original registration timelines issued earlier, over the last few years, due to huge backloads and inadequate approval staff.

The law also creates an emergency registration procedure to permit the use of devices needed to respond to natural disasters, catastrophes, and pandemics.

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.