Replacing decree #98 with decree #07 will implement new device regulations in Vietnam. To help alleviate price fluctuations of devices in Vietnam, Vietnam initiated a policy that device traders or manufacturers need to list device prices on the Vietnam medical device portal and other appropriate places.
Now, under decree #07, not all device prices need to be listed. Instead, the MOH will outline which devices will be required to list their prices. In addition, import licenses received from January 1, 2018, to December 31, 2021, are lawful until December 31, 2024. Class C and Class D devices that do not require import licenses can also be imported until December 31, 2024, with no restrictions on import amounts. Finally, Vietnam will not be required to follow the ASEAN CSTD until January 2024, instead of January 2023.
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.
Source used in the article:https://www.trade.gov/market-intelligence/vietnam-medical-device-registration-0#:~:text=The%20medical%20device%20registration%20numbers,extended%20to%20December%2031%2C%202024.