Vietnam: Diagnostics

Common Technical Document (CTD) Acceptance

Vietnam uses the ASEAN Common Technical Dossier (ACTD) format. Vietnam will adopt the the Common Submission Dossier Templates - the ASEAN Medical Device Directive format.

Clinical Trial Data Requirements

The DMEHW will accept foreign clinical trial results if the device has been accepted and is registered in the country of origin. The results must be approved by the MoH's Science and Technology Council. If the MoH decides that clinical trials must also be conducted in Vietnam for a device, the MoH organizes and conducts trials itself in three or more hospitals.

For devices that require clinical trials and no trials have been performed outside or inside of Vietnam, the Investigator is responsible for preparing a clinical trial protocol. The application should be submitted to the Science and Training Department before the 20th of the month. Within 30 days, the application will be examined. The DMEHW will help coordinate the trial. 15 days following the trial, the Science and Training Department will inform the Investigator if supplementary information is necessary. The Ministry of Health will approve or reject the clinical trial results within 15 days. 

Clinical Trials Import Authorization

If clinical trials are not required, within 15 working days of receiving an application dossier the DMEHW will grant an import license.

The application for importing a medical device requires the following:
-Description of the purpose of importing.
-Agreement to ensure quality, type, and quantity of the medical device.
-Certificate of Free Sale.
-Technical requirements (description of the device, list of components and accessories, intended use, user guide, contraindications, warning and caution, information about adverse effects that could occur, information about the device from other countries, list of registered indications and countries, safety information).

To obtain an Import Permit an application dossier must be submitted and contain the following, in this order exactly:
-Import Permit application.
-Notarized copy of the Enterprise Registration Certificate or Investment Certificate.
-Current certificate of compliance with ISO 13485 or ISO 9001 for each imported device.
-Certificate of Free Sale from country of manufacture.
-Authorization letter from manufacturer/distributor or import/sell.
-Copy of product catalogue.
-Technical documantion.

More information on import requirements are listed in Circular No. 24/2011/TT-BYT.

Clinical Trial Estimated Timeline

45-60 days.

Clinical Trial Costs

For locally-manufactured medical devices, a fee of 300,000 VND per dossier. Import permits are 200,000-3,000,000 VND.

Precedent (Clinical Trials Approved/Denied in Last 2 Years)

3 clinical trials approved from June 2012 to June 2014.

Product Registration Data Requirements

See import authorization.

Product Registration Estimated Timeline

See import authorization.

Product Registration Costs

See import authorization.

Last Updated

September 22, 2014.