Medical device importation to Vietnam
Only registered medical devices may be imported into Vietnam, that means they must be registered with the Department of Medical Equipment and Construction (DMEC) of the Vietnamese Ministry of Health (MoH) and been issued with a Notification of Applicable Standard or Circulation Registration Certificate unless exempted from registration (see below). All medical devices and in-vitro diagnostics that are in circulation in Vietnam as well as those that are exported are listed in the DMEC portal system.
What are the requirements for importing medical devices into Vietnam?
- In order to import a medical device into Vietnam, a company must first obtain a valid Establishment License from the Department of Planning and Investment; only Vietnamese companies can apply for an establishment license
- Importers may also require a valid Certificate of Medical Device Trading for classes B, C and D
- The relevant product license issued by Department of Medical Equipment and Construction is also required prior to importation. This is issued once the medical device has been notified or registered according to its classification.
- Class A and B medical devices require the Notification of Applicable Standard as proof of notification prior to import Class C and D medical devices require a Circulation Registration Certificate as proof of registration prior to import – see next point Medical devices listed in Appendix 1, Circular 30/2015/TT-BYT, currently require an additional Import License issued by the DMEC in order to gain customs clearance. This requirement is for all imports of medical devices on the list up until 31st December 2022 when new rules will enter into force requiring all Class C and D medical devices to simply obtain a product license.
- Multiple importers of the same medical device are allowed in Vietnam but please note that each importer must register the device separately to obtain the relevant product license and import license if applicable. Every time you register the device it will be evaluated as a new device application and therefore the registration fees are applicable each time
- Please note that transfers of product licenses are not allowed in Vietnam; therefore, it can prove judicious to appoint an independent local authorized representative to register and import your medical device giving you freedom in your distribution strategy; you may even appoint multiple distributors
- Certain medical devices may require additional licenses from the Ministry of Information and Communication such as for wifi/bluetooth connections prior to import
- Medical devices which are measurement instruments require additional documentation such as sample approval, inspection and calibration under Ministry of Science and Technology responsibility.
Are there any exemptions or exclusions?
- Certain products may be imported using Special Access Routes (see below).
Special Access Routes for importing medical devices into Vietnam
- Exemptions from the registration process are made for products used for RUO (research use only), testing, training, repairing, exhibition, or donated devices. Such devices must apply apply via a special Import Permit procedure.
Importers duties and obligations
It is mandatory for importers of medical devices and IVDs to Vietnam to store the following quality control documents:
- Certificate of Origin
- Certificate of Quality for each batch of the medical device issued by the manufacturer
- Inspection results of medical devices (required for devices specified in Decree 36/169))
- Distribution documents.
Importers must also:
- maintain a valid Importer’s Establishment Licence
- a valid Certificate of Medical Device Trading for classes B, C and D if applicable
- maintain a record of all imports (and exports)
- provide appropriate storage conditions and means of transportation to maintain the safety and quality of imported products
- have a system to monitor and manage the export, import and inventory of medical equipment containing narcotics and precursors if applicable
- maintain records of any complaints
- report any Adverse Events (AE) or other Post marketing surveillance activities to the Vietnamese Ministry of Health.
How Andaman Medical can help with importing medical devices to Vietnam:
Andaman Medical holds a valid license to operate as an importer of medical device and in-vitro diagnostics as well as being able to authorize other third parties to import medical devices and in-vitro diagnostics. We remain independent from any final distribution channel partner you choose to appoint, giving you freedom in your distribution strategy, you may even appoint multiple distributors. Our regulatory affairs specialists and logistics executives will help you to:
- register and import your medical device
- ensure that your product registrations are valid at all times.
- keep you abreast on the recent changes or new regulations pertaining to medical devices
- facilitate customs clearance
- maintain post-market surveillance of your registered product
- liaise with your appointed distributors and the Vietnamese Ministry of Health concerning the mandatory reporting of Adverse Effects and other Post marketing surveillance activities.
We also offer additional support services such as:
- Online regulatory training
- Regulatory intelligence reports giving you insight into the best routes for market access and the latest on the regulatory landscape in your target market.