Vietnam Releases New Medical Device Regulations

The MOH officially released Decree 98/2021 ND-CP, which implements significant new changes to the medical device registration process in Vietnam.

Vietnam’s MOH Holds Conference on Price Declaration

The conference was held to provide clarity to the Price Declaration process and announce the establishment of a new online portal for license holders to declare prices. This comes as many provincial health services, including Ninh Binh and Dak Nong, have not been able to purchase medical products since January 1, 2022.

VietNam: High Growth Fast Market Access

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.

Vietnam Requires Resubmission of Many Medical Device Registration Applications

All unapproved Class B, C and D MA License applications have been returned for resubmission for compliance to the new requirements.

VietNam Expedites Registration of COVID-19 Related Medical Devices

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.

VietNam’s MOH to Require CSDT Documentation for Class B, C, and D Devices

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.

Vietnam Launches Medical Device Pricing Portal

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.

Vietnamese MOH Establishes New Medical Device Advisory Council

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 to Require Annual Inspection of Certain Medical Equipment

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.

Navigating the New Vietnamese Public Medical Device Pricing Portal

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.