The exportation of medical masks has now been authorized by the Vietnamese Government following the repeal by the Ministry of Health of the licensing ban. This is regulated for in the newly issued Government Resolution No.60/NQ-CP dated 29 April 2020. This means that the Government’s Resolution No. 20/NQ-CP dated 28 February 2020 on export licensing regulations are annulled.
With the new authorization of exportation of medical masks and the high demand for these items in many countries, the Vietnamese government simultaneously issued an official dispatch No.2507/BYT-TB-CT dated 07 May 2020 listing requirements for local companies who wish to begin the exportation medical masks (exporters) into foreign countries. And at the same time, the Vietnamese government has issued appropriate administration measures to ensure the adequate supply of medical masks for epidemic prevention and control in Vietnam.
Exporters shall be responsible for the quality of exported medical masks and guarantee to sell medical masks to local health facilities in Vietnam on demand.
To ensure the quality of medical masks, manufacturers must strictly comply to the following government instructions:
- The manufacturer of medical masks must be certified ISO 13485:2016 and that certificate has been issued by an establishment that has adopted Vietnam regulation Decree 107/2016 ND-CP dated 01 July 2016 for the provision of conformity assessment services. The list of published on website of Directorate for Standards, Metrology and Quality
- Medical masks must meet one of the following standards: TCVN 8389-1:2010, TCVN 8989-2:2010 or TCVN 8989-3:2010. Manufacturers for both domestic and export supply must provide the following additional documentation:
- Manufacturer’s Declaration of Conformity,
- Physicochemical parameters result of medical mask testing,
- Declaration of eligibility to produce medical equipment,
- Product license class A for medical masks.
- For those manufacturers who wish to export, the exporters should fully understand requirements and standards set by importing countries, to avoid any issues concerning quality and to avoid any refusal to import and the subsequent return of goods.
If you have any queries regarding the exportation of medical masks from Vietnam or our services for medical device registration and representation in Vietnam, please contact us at email@example.com.