What is the application for the issuance of registration number for Class-C and Class-D medical device in Vietnam?
- What is the application form for the issuance of registration number for Class-C and Class-D medical device in Vietnam?
- What are the requirements for organizations declaring applied standards or applying for registration number for medical devices in Vietnam?
- What are the procedures for the issuance of registration number for Class-C and Class-D medical device in Vietnam?
What is the application form for the issuance of registration number for Class-C and Class-D medical device in Vietnam?
Pursuant to the provisions of Form No. 03.05 of the Appendix issued together with Section 5 of Decision 2962/QD-BYT in 2023, stipulating the application form for the issuance of registration number for Class-C and Class-D medical device:
Download the application form for the issuance of registration number for Class-C and Class-D medical device here
What is the application for the issuance of registration number for Class-C and Class-D medical device in Vietnam?
What are the requirements for organizations declaring applied standards or applying for registration number for medical devices in Vietnam?
Pursuant to the provisions of Article 25 of Decree 98/2021/ND-CP stipulates as follows:
Requirements for organizations declaring applied standards or applying for registration number for medical devices
1. Organizations that declare applied standards or apply for registration number for medical devices include:
a) Vietnamese enterprises, cooperatives or household businesses that are product owners;
b) Vietnamese enterprises, cooperatives or household businesses that are authorized by product owners;
c) Permanent representative offices in Vietnam of foreign traders that are product owners or authorized by product owners.
2. The organization declaring applied standards or applying for registration of a medical device must establish and maintain a warranty center in Vietnam or sign a contract with a qualified warranty center, except disposable medical devices as defined by product owners or cases where there are documents proving that the medical device is not under warranty.
Where the organization declaring applied standards or applying for registration of a medical device is the entity prescribed in Point c Clause 1 of this Article, the product owner must establish and maintain a warranty center in Vietnam or sign a contract with a qualified warranty center, except disposable medical devices as defined by product owners or cases where there are documents proving that the medical device is not under warranty.
The warranty center must be granted certificate of eligibility to provide warranty by the product owner.
According to the above regulations, organizations declaring applied standards or applying for registration number for medical devices include:
- Vietnamese enterprises, cooperatives or household businesses that are product owners;
- Vietnamese enterprises, cooperatives or household businesses that are authorized by product owners;
- Permanent representative offices in Vietnam of foreign traders that are product owners or authorized by product owners.
At the same time, organizations declaring applied standards or applying for registration number for medical devices must satisfy the conditions as prescribed above.
What are the procedures for the issuance of registration number for Class-C and Class-D medical device in Vietnam?
Pursuant to Section 5 of Administrative Procedures promulgated together with Decision 2962/QD-BYT in 2023 on procedures for the issuance of registration number for Class-C and Class-D medical device as follows:
Step 1: The organization requesting the issuance of a free-sale registration number shall submit a dossier to the Ministry of Health through the Information System for handling administrative procedures of the Ministry of Health (https://dichvucong.moh.gov.vn) or the Portal. electronic management of medical equipment (https://dmec.moh.gov.vn/).
Step 2: In case there is no request to amend or supplement the application for registration of circulation, the Minister or the Ministry of Health is responsible for: Organizing the appraisal to issue registration number within 45 days from the date of receipt the complete and valid dossiers (including papers certifying payment of fees for appraisal and issuance of circulation permits according to regulations of the Ministry of Finance). In case of refusal to issue a free-sale registration number, there must be a written reply clearly stating the reason.
If the application for registration of free sale is incomplete, the Ministry of Health must notify the organization requesting the issuance of a free-sale registration number to supplement or amend the application for registration of free sale. which documents and contents need to be modified within 40 days from the date of receipt of a complete and valid dossier.
Step 3: When receiving a request for addition or modification of the application file for a free-sale registration number, the applicant establishment must supplement and amend it according to the notified contents and send it to the Ministry of Health.
In case the establishment applying for a free-sale registration number has added or modified its dossier but it is not in accordance with the requirements, the Ministry of Health will notify the establishment to continue to complete the dossier according to regulations.
After 90 days from the date the Ministry of Health issues a notice of the request, but the establishment does not supplement or amend the dossier, or if after 03 times of amending and supplementing the dossier from the date the Ministry of Health requests the amendment, If the dossier is supplemented for the first time but still does not meet the requirements, the procedure for applying for a free-sale registration number must be repeated from the beginning.
Step 4: Within 01 working day from the date of issuance of the free-sale registration number, the Ministry of Health is responsible for publishing on the electronic portal on management of medical equipment the following information:
- Name, classification, manufacturing facility, country of manufacture of medical equipment;
- Circulation number of medical equipment;
- Name and address of the owner of the medical equipment;
- Name and address of the owner of the circulation number;
- Name and address of the medical equipment warranty establishment;
- Documents in the application for registration of circulation of medical equipment, except for the General Technical Dossier for medical equipment according to ASEAN regulations.
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