Two months after Vietnam issued a new decree simplifying the registration of medical devices, the country’s Ministry of Health has announced that thousands of pending device applications will have to be resubmitted to ensure they comply with the new requirements.
The move affects all unapproved Class B, C, and D, MA license applications to ensure they comply with Decree 98/2021. The decree streamlines the approval process for many devices and allocates device registration numbers for all except those granted emergency use authorization valid indefinitely. But it includes slight changes to application requirements, and unless applications submitted prior to the implementation of the new decree are resubmitted, regulators cannot ensure that devices comply.
New applications will not be subject to any new fees, and their requirements largely mirror those of previous applications. But unlike in the past, they must include a declaration of conformity and a clinical evaluation report. Authorities promise to expedite reviews and approvals of the more than 6,000 applications affected by the change.