Vietnam MoH

Vietnam Medical Device Registration

The medical device market in Vietnam is one of the fastest growing in the Asian region due to the government’s recent hospital improvement efforts. More than 90% of medical devices in Vietnam are imported. Qualtech  is your ideal partner to for your foray into the Vietnam medical device market for an easy and smooth registration process.

Qualtech in Vietnam

Expert in Non-Active Device

Our team has assisted several non-active device to access Vietnam market efficiently. Our experience covers contact lens, facial filler, adhesive gel… and other devices.

Market Access Strategy

Qualtech Vietnam team offer clients ONE-STOP market access service, covering Regulatory research, Registration, Importation, Distributor connection.

 

 

QT Services
 
 
 
 

Medical Device Registration

Our in – house experts are able to provide you with excellent professional service in preparing customized ASEAN Common Submission Dossier Template (CSDT) and liaise with DMEC officers to get your devices registered in the Vietnam.

 
 

Authorized Representation

As an in – country authorized representative (AR), Qualtech can hold a medical device registration license on behalf of foreign manufacturers looking to market medical devices in the Vietnam. This is in compliance with the law for a local establishment to be a license holder.

 
 

Importation

The local distributor you are looking is sometimes not a qualified importer, or is not familiar with the importation process of medical device. Qualtech has extensive experience in importation in many regions of Asia, assisting several customers to handle customs clearance of various medical equipment imports. We can assist your products to be delivered to customers smoothly!

 

Registration with DMEC

Ministry of Health (MoH) is the Institution to manage medical device affaires. Under MoH, the Department of Medical Equipment and Construction (DMEC) and Department of Health (DoH) are the regulatory body that governs the registration and approval of all medical devices. In old regulation, the registrant shall obtain Import Permit License for particular medical devices to import medical device into Vietnam. The New Medical Device Regulation is planned to implement on 2022.

Major Change in New Regulation:

  • The medical device would be classified as product risk.
  • The registered medical device would be issued Marketing Authorization License. (MA License)
  • The registrant shall refer to CSDT regulation to submit the technical document during Class B, C and D registration.
Classification
 
 

 

Class A

Low risk device

MA License

Online submission

Class B

Low-Moderate Risk

MA License

Online submission

Class C

High-Moderate Risk

MA License

Online submission

Class D

High Risk

MA License

Online submission

 

 

TECHNICAL REQUIREMENTS

Qualtech CLASS A CLASS B CLASS C CLASS D
Executive Summary   Yes Yes Yes
Essential Principles and Methods   Yes Yes Yes
Device Description Yes Yes Yes Yes
Summary of Design V&V Yes Yes Yes Yes
Labeling and IFU Yes Yes Yes Yes
Risk Assessment   Yes Yes Yes
Physical Manufacturer Information Yes Yes Yes Yes
Summary of clinically testing data   Yes Yes Yes
PMS Report   Yes Yes Yes

Note: Kindly see the Decree 36/2016 and Decree 169/2018/ND-CP for more details.This requirement will be implemented from 2022.

 
Workflow
 
 

DoH/DMEC Target Reviewing Turnaround Time

After successful internal evaluation of the submission dossier, our in – house experts will then submit it to the DoH/DMEC and will be subjected to thorough evaluation. Below is a list of the turnaround times for different types of transactions involving product registration/notification.

  CLASS A CLASS B CLASS C CLASS D
Registration 7 60 60 60
Compliance NA 90 90 60
Note: It's accounted as calendar days.
Validity
 
 
  • Types of Certificates: Marketing Authorization License

  • Product Certificate pf Class A: Permanent

  • Product Certificate pf Class B, C and D: 5 years

 
Workflow
 
 
How Could I Obtain Faster Market Access?

With coming new regulation, the threshold of accessing Vietnam market becomes higher. Every foreign manufacturer would like to have their product access Vietnam market immediately. It’s good news that DMEC offers TWO routes of faster market access to shorten the registration timeline.

The product has been registered in at least 2 approvals of the following countries: Japan, Canada, Australia, United States, or EU member country.

The product was on-marketed in Vietnam prior to December 31, 2018, and satisfies both of the following conditions:

(i) was circulated for at least 03 years within the period of five years before the submission date, and

(ii) no warnings about the quality or safety of the product.

For more information, please refer to the Vietnam DMEC's official website or you may contact us for a free consultation.

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Official Website
 
 

 

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