The Ministry of Health, Vietnam has shared with attendees of a business dialogue that the validity of import licenses and the effective date for product licenses Class B, C and D will be extended. The official announcement has been published on the government website..
The Ministry of Health (Department of Medical Equipment and Construction), Vietnam organized a business dialogue conference (3rd of Dec 2019 in Hanoi and on the 14th of Dec 2019 in Ho Chi Minh city) focussing on the regulations of the management of medical equipment and asked for comments on policies supporting the development of domestic production of medical equipment.
The general guidelines about import licenses and product licenses are:
• The import license is valid until 31st of December 2021 for Class B, C, D medical devices for all import licenses issued in 2018 (valid on 31 December 2018) and all import licenses issued in 2019.
• For Class B, C, D medical devices that do not require an import license, importation can continue as normal until 31st of December 2021 without the requirement for a Confirmation Letter from the Vietnamese Ministry of Health.
• Vietnam will apply the Common Submission Dossier Template format until the 1st of January 2022.
In conclusion, the Ministry of Health will expand the valid date for import licenses until the 31st of December 2021 and, the effective date of product licenses for the next two years (1st of January 2022). Every registrant should understand the medical devices that are being registered and the regulations surrounding these.
The new decree is released to public early this month, January 2020. For further information, please refer to the following website: www.dmec.moh.gov.vn