Introduction – Medical Device Registration in Vietnam 

This article deals with the Medical Device Regulations in Vietnam. The Ministry of Health (MOH) governs the registration and approval of all Medical Devices in Vietnam along with the Department of Medical Equipment and Health Works (DMEHW). The Southeast Asian Nations which consist of 10 countries and health care being the highest priority of all, the authorities help in taking care of all the trade barriers. The AHWP, (Asian Harmonization Working Party), APEC(Asia-Pacific Economic Cooperation) and ASEAN (Association of SouthEast Nations) are the authorities which govern the overall regulations for all the 10 countries such as – Thailand, Indonesia, Malaysia, the Philippines, Singapore, Brunei, Vietnam, Laos, Myanmar and Cambodia. Registering all the Medical Devices in Vietnam is mandatory before they are sold and distributed in the country. In 2016 the MOH released Decrees 36 & 39 which states that  DMEHW is in charge of all Medical Device Registrations. 

Agent

The first step towards the Regulatory Compliance is by appointing a Local Agent. They handle the assessment for all the Medical Devices and the registration and importation of the Medical Devices into the Country. 

Process of Registration – Documents Needed 

All approval from the country of origin, including CE Mark certificate and U.S. FDA approval, must all be submitted. For all Class A Medical Device products, the application can be submitted along with the administrative documents, such as Letter of authorisation and Certificate of Free Sales has to be submitted either in Vietnamese or in English language. All Licenses issued for Class A, are valid indefinitely. For Class B, C and D, to get the Market Authorization License, the manufacturer needs to submit the Technical data demonstrating the device conformity assessment to the ASEAN MDD which is in a common Dossier Submission Template (CDST) format along with a Quality Management System complying with ISO 13485:2016. The MA license is issued and it has a validity of 5 years.

The documents required for Class A Device Registration is given below – 

  • Application form
  • Classification table of registered device
  • Declaration of Class A application
  • Quality control standards certificate
  • Authorization letter by device’s owner
  • Conformity certificate
  • Eligibility certificate for warranty
  • Written instructions for device
  • Free sales certificate
  • Device label

Class B, C & D Device, in addition to the above mentioned documents will also need to submit the below given documents:

  • Manual with device specifications, functions and technical information
  • Device description in brief
  • Clinical testing data summary (Class C and Class D only)
  • Certificate of Inspection (Class C and Class D only)

Importations

Once the approval is obtained, the manufacturer can import into the Country. The following documents are needed for the Importation of the Medical Devices – 

  • A written request for the issue of Form No.01
  • Valid Certificate of Free Sales Certificate
  • ISO Certification
  • The Valid Letter of Authorization as per Form specified in Annex III
  • The Technical Material in Vietnamese language (Form No. IV)
  • Catalogue Describing the Functions
  • Technical Parameters
  • The Clinical Assessment
  • Manufacturers or the Owner should submit Medical Equipment Manual and Details of the Material 
  • As Specified in section 49 of Annex I, issued in the Circular.
  • According to article 10 of Circular 30/2015/TT-BYT.
  • Equipment import Permit and the List of other countries in which this Device is approved and its Safety Information

How can Morulaa Help ?

Morulaa HealthTech as successful Regulatory and Import Consultants have delivered high levels of professionalism towards our clients. To understand how the regulatory approval system works in Vietnam and other South East Asian Countries,  contact us to know more.


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