As manufacturers finish transitioning to the new EU MDR requirements, it will be important to understand the implications of these changes on existing licenses around the world.
A list of recently updated articles regarding medical device regulatory updates from the MOH and other governing bodies in Vietnam.
Manufacturers looking to Southeast Asia to help grow their medical device sales will need to become familiar with the Common Submission Dossier Template, or “CSDT.”
The MOH officially released Decree 98/2021 ND-CP, which implements significant new changes to the medical device registration process in Vietnam.
On May 15, 2021, the VietNamese Ministry of Health (MOH) released new Guidance announcing Class B, C, and D devices will need to submit their applications in accordance with the ASEAN Common Submission Dossier Template (CSDT) format.
With the release of Circular 13/2021/TT-BYT on September 16, 2021, the VietNamese Ministry of Health has provided a new, expedited review process for specified medical devices related to COVID-19.
On December 31st, 2020, the Ministry of Health (MoH) issued Circular No. 30/2020 providing a list of medical equipment subject to annual safety inspections and technical capability assessments, along with the timelines for implementation.
The new Medical Device Pricing Portal was opened to the public on November 20th with the goal of setting new international standards for medical device sales transparency. The medical device section is split into 2 sections, the Medical Equipment Price and Pricing Information on Winning Bids. On one side, users can view product listings and on the other, review all final government purchases, including contracted pricing.
On September 9th, the Vietnamese Ministry of Health (MoH) officially opened the Information Portal of Medical Equipment Pricing. Under the new system, the list price of medical equipment will be published (by configuration) on this Ministry of Health hosted website.
On November 18, 2020, the Vietnamese Ministry of Health (MOH) released Decision No. 4353 / QD-BYT officially establishing an Advisory Council to help with the regulatory transition.
Vietnam has been quietly transforming their economy of 100 million people into a regional powerhouse. Through a combination of significant private investment, the US-China trade war, and their highly successful handling of the Coronavirus, Vietnam’s economy is expected to rebound quickly, especially with regards to manufacturing.