On 27 December 2024, the Civil-Economic Legislation Department (Ministry of Justice) – at the request of the Ministry of Health – hosted the legal review of the Draft Decree amending Decree 98/2021 on Extension Medical Device Import License in Hanoi. Representatives from Civil-Economic Legislation Department, Government Office, US-ASEAN Business Council, Vietnam Chamber of Commerce and Industry (VCCI), and Saint Paul Hospital attended the meeting.
Attending on behalf of EuroCham Vietnam, members from the Medical Devices and Diagnostic Sector Committee (MDD SC) voiced support for the proposed amendments. Attending representatives from EuroCham’s MDD SC include:
- Mr. Hieu Nguyen – Co-head of Regulatory Affairs Working Group
- Mrs. Nguyen Thu Hang – Co-head of Government Affairs and Market Access Working Group
- Mrs. Doan Thi Thanh Thuy – Co-head of Government Affairs and Market Access Working Group
Together, delegates from governmental agencies, business associations and other relevant units reached a consensus on the amended content and agreed that the Draft Decree is eligible for further legal proceedings.
In particular, the meeting reviewed the Decree amending and supplementing multiple articles of Decree No. 98/2021/ND-CP dated November 08, 2021, on management of medical devices. The draft decree will amend and supplement Clause 2, Clause 3, Clause 4, Article 76 of the mentioned Decree to allow a 6-month extension for medical device import license. The last amendments and supplementations to this regulation were made via Decree No. 07/2023/ND-CP on 03 March 2023.
