GUIDELINES FOR REGISTERATION OF MEDICAL DEVICES

Enterprises need to register medical devices with the relevant authorities as outlined in Decree 98/2021 ND-CP. This registration allows health agencies to inspect and monitor the quality of the devices, helping them quickly identify and address any issues. In this article, we’ll explore the latest process for medical device registration with MEDGATE.

Table of Contents

What is the registration of medical devices for circulation?

Registration of medical devices for circulation is a mandatory procedure before they are circulated on the market. For medical devices of class A and B, enterprises must register to declare the applied standards to the Department of Health where the business is located. For medical devices of class C and D, enterprises must apply for the registration number according to specific regulations clearly stated in the instructions of Decree 98/2021/ND-CP issued in 2021, Circular 19/2021/TT-BYT issued in 2021, Circular 278/2016/TT-BTC issued in 2016.

Requirements for application for registration of medical devices

So what does the medical device registration file include?

For each specific case, the registering enterprise needs to provide specialized documents.

Type of registration dossier

Medical device has corresponding national technical regulations

Medical device is a measuring device that must have a sample approved.

Medical device is a in the case of quick issuance

Document shared

– The application form for issuance of a new registration number

– An unexpired certificate of conformity with ISO 13845 quality control standards.

– The unexpired letter of authorization given by the product owner to the organization that applies for registration.

– The certificate of eligibility to provide warranty granted by the product owner, except disposable medical devices defined by product owners or cases where there are documents proving that the medical device is not under warranty.

– The unexpired CFS (for imported medical devices).

– ASEAN Common Submission Dossier Template (hereinafter referred to as “CSDT”).

Procedure for registration of medical devices

Step 1: Prepare and submit application

Organizations prepare the registration dossier for medical devices class C and D according to the required documents as above. Then, the business establishment submits the dossier to the Ministry of Health through the Electronic Portal on Medical Device Management.

Step 2: Receiving and evaluating documents

The Ministry of Health shall organize the appraisal of medical device circulation registration dossiers within 30 days from the date of receipt of complete and valid dossiers in case there are no requests for amendments or supplements.

In case the registration dossier is not complete, the Ministry of Health must notify the organization to supplement or amend the registration dossier. Accordingly, it must specify which documents need to be supplemented and which content needs to be amended within 25 days from the date of receiving the complete and valid dossier.

Upon receiving a request for addition or modification, the organization must add or modify in accordance with the notified contents and send it to the Ministry of Health.

Within 90 days from the date of notification, if the facility does not supplement or amend the dossier or if after 05 times of amending or supplementing the dossier the dossier still does not meet the requirements, the procedure must be re-done from the beginning.

Step 3: Granting registration number

The Ministry of Health shall issue a registration number to the organization when all required documents have been fully and validly completed. Within 01 working day from the date of issuance, the Ministry of Health shall be responsible for publicizing the following information on the Electronic Information Portal on Medical Device Management :

a) Name, classification, manufacturing facility, and country of manufacture of medical device ;

b) Circulation number of medical devices;

c) Name and address of the owner of the medical device ;

d) Name and address of the owner of the registration number;

d) Name and address of the medical device warranty facility ;

e) Documents in the registration dossier

Step 4: Monitoring and supplementing after granting the registration number

During the process of circulating medical device, the owner of the circulation number is responsible for preparing a written notice of changes, along with documents related to the changes, and updating those documents in the circulation registration dossier publicly available on the Electronic Information Portal on Medical device Management within 10 working days from the date of one of the following changes:

a) Change of address of the circulation number owner or the name of the medical device owner;

b) Change the name of the circulation number owner or the name of the medical device owner;

c) Change one of the following information: name, address of the medical device manufacturing facility ;

d) Change packaging specifications;

d) Change of warranty facility;

e) Changing the label, changing the instructions for use but not changing the purpose of use, indications for use, features and performance of the medical device.

To learn more about medical device registration and the process to issue a medical device circulation number at MEDGATE , please contact Hotline: 098.546.1894 or Email: medgatevn@gmail.com for advice on document services, procedures, price quotes for registration, circulation announcement, and advertising of medical device.

Medical Devices