From 01 July, 2016, the new decree 36/2016/NĐ-CP on Medical Device Management came into effect and it is predicted that these new medical device regulations will have an impact, not only on product registration, but also on trading, importation, manufacturing and market circulation in Vietnam.
An important change in the new medical device regulations is that medical devices are now classified based on a risk classification (group A, B, C, D), rather than function classes (equipment for operation, sterile devices, equipment for anesthesia, etc) as before. Class A medical devices will be managed by the local health department and the product license remains permanently valid. Class B, C and D medical devices will be managed by the Department of Medical Equipment and Construction, Ministry of Health (MOH) of Vietnam. Product licenses will be valid for 5 years from the date of issue. The MOH of Vietnam also issued a guideline for medical device classification and recognition of classification results from the US-FDA, EU, TGA (Australia), Canada, Japan, Korea and the ASEAN region.
Previously, according to the circular 30/2015/TT-BYT on Importation of Medical Devices, there were only 49 types of medical device that required an import license. Devices that were excluded from the list could be freely imported. The new medical device regulations will prevent this situation and the perceived inequalities between domestic and imported goods.
2017 is the transitional year for the phasing out of the old regulations and the implementation of the new regulations. With the new product license, medical devices can be imported or exported with no limits on quantities. From 01 July, 2017 to 31 December, 2017, Class A medical devices are only allowed to be imported with a notification receipt from the local Department of Health. The importer is required to submit the classification result and letter of authorization of the license holder (if the importer is not the product holder). Class B, C and D medical devices that appear on the importation list (in circular 30/2015/TT-BYT) will need to have an import license and classification result to be imported. For those devices excluded from the list, the importer has to show the classification result when importing the products. From 01 January, 2018, Class B, C, and D medical devices will be required to have a registration number for importation. IVDs that have a registration number approved before 31 December 2017, can continue to be imported until the expiry date of the license.