Overview

Vietnam’s Medical Device market is picking up over the years and is currently one of the booming sectors in the country. Medical Devices in the country are regulated by Department of Medical Equipment and Health Works (DMEHW) under Ministry of Health. The devices are classified into 4 classes (A, B, C and D) which are also categorized into two groups, group 1 (Class A) and group 2 (Class B, C and D). Appointment of reliable and capable Vietnamese agent for foreign manufacturers is crucial as they must undertake the warranty services offered by manufacturer as part of the device sale. Translation to Vietnamese is a must to enter the region, which indeed can be challenging in actual practice.

Freyr offers Regulatory support extending the complete range of activities such as procuring Free-sale Recognition Number involved in medical device approval from authorities. We also provide linguistic expert support to maintain the Regulatory perspective of the translation intact. We cater to the post-approval needs of clients to maintain compliance throughout product lifecycle in Vietnam. 

Vietnam Market Entry for Medical Devices - Process Flow

Vietnam Medical Device Regulations

 

Freyr Expertise

  • Regulatory Assistance in Registration Process
  • Medical Device Classification
  • Support in Free-sale Registration Number (FRN) Procurement
  • Local Authorized Representation

Summary

S.No

Regulatory Parameter

Vietnam

1

Regulatory Authority

Department of Medical Equipment and Health Works (DMEHW)

2

Regulation

Decree 36/2016/NĐ-CP (Medical Equipment Management)

3

Risk Classification

Type A - Group 1

Type B - Group 2

Type C - Group 2

Type D - Group 2

4

Regulatory Pathway

Type A

Declaration of applicable standard

Type B, C & D

Certificate of free-sale registration

5

Authorized Representative

Required

6

Fee payable

~ $ 200*

7

QMS Requirement

ISO 13485

8

Assessment of Technical Data

Department of Medical Equipment
and Construction (DMEC) of MoH

9

Validity of License

Type A

Unlimited

 

 

Type B, C & D

5 Years

10

Labelling Requirements

Article 54 of Decree 36/2016/NĐ-CP

11

Submission format

Online

12

Final Outcome

Free-sale registration number

13

Timelines

15 - 60 days

14

Language

English & Vietnamese

*The price is as per records at the time of documentation and is subject to change.