Medical Device Product Registration and Approval in Vietnam
MEDICAL DEVICE REGULATION IN VIETNAM
Medical devices are regulated by the Department of Medical Equipment and Construction (DMEC) from the Ministry of Health in Vietnam. Medical devices are regulated under different Circulars.
· For importing of medical devices by the Vietnamese traders and the importers, Circular No. 30/2015 for Non-IVD MD; Circular 47/2010 for IVD MD.
· For local manufactures medical device for circulation by Vietnam manufacturers or facilities, Decree 36/2016/NĐ-CP·
· For new regulation: Decree 36/2016/NĐ-CP
Some other general goods law also applies to the medical device.
MEDICAL DEVICE REGISTRATION AND APPROVAL IN VIETNAM
An import permit is required before the medical device is allowed to be imported into Vietnam if the imported device is on the list in Circular No. 30/2015/TT-BYT. The list of medical devices that requires an import license currently contains 49 product types. The list is subjected to a yearly revision if any, and any add-on to meet the practical status and suitability to the regulatory control on medical device importation.
Some new products also require an import license from the MOH although it is not on the list. ARQon is able to assess if the product requires an import license.
Under the new regulation: the documents to be submitted should be the same format found on the Vietnam application form. The format section is similar to the Executive summary of the ASEAN CSDT. However, this information must be in the Vietnamese language. In addition, there are other documents required to be prepared by the manufacturer.