Medical Devices Regulatory Services
in Vietnam

Overview

Vietnam’s Medical Device market is picking up and is currently one of the booming sectors in the country. Medical Devices in the country are regulated by the Department of Medical Equipment and Health Works (DMEHW) under the Ministry of Health.

Regulatory Authority: Department of Medical Equipment and Health Works (DMEHW)

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

Authorized Representative: Required

QMS Requirement: ISO 13485:2016

Assessment of Technical Data: Department of Medical Equipment and Construction (DMEC) of MoH

Labeling Requirements: Article 54 of Decree 36/2016/NĐ-CP

Submission Format: Online

Timelines: 15 - 60 days

Language: English & Vietnamese

Vietnam Medical Device Classification

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). Formal classification is available with the Vietnam Department of Medical Equipment and Health Works (DMEHW).

Group

Class

Risk

Group 1

Class A

Low Level

Group 2

Class B

Lower average level of risk

Class C

Upper average level of risks

Class D

High level of risks

Vietnam Legal Representative

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 the product lifecycle in Vietnam.

Vietnam Medical Device Registration

Group 1 / Class A devices shall submit the declaration of applicable standard. Whereas, Group 2 / Class B,C,D shall obtain Certificate of free-sale registration to market the devices in Vietnam.

Process flow:

Post Approval Device Life Cycle Management

Freyr supports the foreign manufacturers in end-to-end Medical Device lifecycle management, including post approval activities, such as:

  • Post approval change management - modifications to existing Medical Device approvals such as, addition of new variants, accessories; addition of new indications of use among others
  • Maintenance of approvals and registration through timely payment of administrative and registration fees
  • Renewal of licenses
  • Liaising between the DMEHW and the manufacturer
  • Importation management

Summary

Group

Class

Risk

Regulatory Pathway

Timelines

Validity

Group 1

Class A

Low Level

Declaration of applicable standard

15 - 60 days

Unlimited

Group 2

Class B

Lower average level of risk

Certificate of free-sale registration

15 - 60 days

5 Years

Class C

Upper average level of risks

Certificate of free-sale registration

15 - 60 days

5 Years

Class D

High level of risks

Certificate of free-sale registration

15 - 60 days

5 Years

Expertise

Freyr Expertise

  • Regulatory Due-Diligence 
  • Official Classification 
  • Device Registration 
  • Import License 
  • Labeling support
  • Translation support
  • Distributor identification and qualification 
  • Post Marketing Surveillance 
  • Post Approval Change Management
  • License renewal and transfer 
  • Submission and liaising 
  • Customs clearance