New Regulations Regarding Importing Medical Devices into Vietnam

Beginning November 20, 2015, all medical devices that are imported into Vietnam are subject to a new set of regulations laid out in Circular 30. This new circular supersedes the previous regulations found in Circular 24 dated June 21, 2011. However, all import licenses that were issued under Circular 24 are still valid until they expire.

Under the new regulations, all medical devices can be imported into Vietnam freely, except 49 device types that are listed in Circular 30. These devices include magnetic resonance imaging systems, bone densitometers, Elisa test systems, diagnostic reagents and chemical, sterilizing agents for medical devices, endoscopic surgery systems, and ophthalmology surgery systems.

In order to import any of the above devices, importers must ensure that all supporting documents are valued and legalized by the Vietnam Embassy in the country of origin. These supporting documents include:

  1. Letter of Authorization
  2. CFS/CFG for all manufacturing sites
  3. ISO 13485 or ISO 9001 for all manufacturing sites
  4. Original catalogue with detailed models / codes
  5. Clinical evidence and IFU for Cardiovascular and Neurosurgical products and for the initial submission

The application process will take at least one month and the approved import license will be valid for one year.