Home About Qualtech NEWS VIETNAM: Ministry of Health issued the Draft Regulation on Medical Device Technical Report - February 2019
VIETNAM: Ministry of Health issued the Draft Regulation on Medical Device Technical Report - February 2019

February 18, 2019

Vietnam Ministry of Health issued the draft new Circular on Medical Device Technical Report to promulgate a set of medical device technical dossier. Moreover, Article 5 of Circular 46/2017/TT-BYT dated December 15, 2017 on Technical Report Guideline is hereby repealed.

This draft Circular applies to all medical devices class B, C, D for both new application and amendment the applications before this Circular publishes. Medical device Technical Report can be presented in Vietnamese or English language.

This Circular is going to take effect from July 1, 2019.

Below is the table to clarify the dossier requirement between Draft new Circular and Decree 36/2016:

VN Feb 2019 1

 

Qualtech Vietnam’s office offers “Registration”, “Local Authorization” and “Importation” services. The global medical device regulatory specialists at Qualtech have practical experience in Vietnam’s regulations and can support you to obtain approval for your product and easy to access the potential market.

 

Reference:

Draft regulation on technical report

 

Follow us here and stay updated on all latest happenings in Asia medical device market and more:

Facebook iconLinkedin iconTwitter icon

 
Home About Qualtech NEWS VIETNAM: Ministry of Health issued the Draft Regulation on Medical Device Technical Report - February 2019