13 cases of having medical equipment registration numbers revoked in Vietnam

13 cases of having the registration number of medical equipment revoked (Illustration image)

Specifically, there are 13 cases of having medical equipment registration numbers revoked, including:

(1) The circulation registration organization forged registration documents.

(2) Medical equipment with 03 batches is recalled during the validity period of the free-sale registration number unless the owner of the free-sale registration number voluntarily withdraws it.

(3) The circulation registration organization corrects, erases, and changes the content of the circulation number.

(4) The owner of the registration number terminates the operation or is no longer authorized by the owner of the medical equipment without an alternative organization, except in the case of the owner of the medical equipment or the owner of the medical device. The owner of the medical equipment circulation has ceased production or is bankrupt or dissolved according to Article 37 of Decree 98/2021 of Vietnam 

(5) Medical equipment circulated on the market does not meet the quality registered for circulation.

(6) The circulation number is not issued according to the authority, dossiers, and procedures as prescribed in this Decree.

(7) Medical equipment that the owner of the free-sale registration number or the distributor has not committed under the provisions of Clauses 1 and 2, Article 37 of Decree 98/2021 of Vietnam 

(8) Medical equipment with the expiry date of circulation as prescribed in Clauses 1 and 2, Article 37 of Decree 98/2021 of Vietnam

(9) Medical equipment manufactured at establishments that do not meet the conditions specified in Decree 98/2021 of Vietnam

(10) The owner of the free-sale registration number fails to comply with the provisions of Point k, Clause 3, Article 74 of Decree 98/2021 unless the owner of the medical equipment or the owner of the free-sale registration number of the medical equipment economy ceases to produce or goes bankrupt or dissolves according to Article 37 of Decree 98/2021 of Vietnam

(11) Dossier of the announcement, registration of circulation of the owner of the free-sale registration number does not comply with the provisions of Decree 98/2021 of Vietnam

(12) Medical equipment is classified incorrectly according to regulations on the classification of medical equipment.

(13) The owner of the free-sale registration number voluntarily withdraws the circulation number.

Procedures for revocation of circulation number

- In the course of examination and inspection, if any of the above cases is detected, the inspection and inspection agency must make a record and send it to the Ministry of Health or the Department of Health of Vietnam where the registration number is promulgated (hereinafter abbreviated as the circulation number-issuing agency).

- Within 5 working days after receiving the minutes, the circulation number-issuing agency shall consider and decide on the revocation of the free-sale registration number under its management.

- After issuing the decision on revocation of the free-sale registration number, the agency issuing the recall decision shall have to:

+ Post the decision on revocation of the free-sale registration number on the web portal of the circulation number-issuing agency, and at the same time send the decision on revocation of the free-sale registration number to the free-sale registration number owner, the Ministry of Health, the Departments of Health of provinces and centrally run cities and customs offices of Vietnam

+ Remove information related to medical equipment that has been posted on the web portal of the circulation number issuer.

- When receiving the circulation number revocation decision from the circulation number-issuing agency, the Departments of Health of Vietnam are responsible for posting the full text of the decision on revocation of the circulation number on the portal, and at the same time directing the agencies to the specialized agency overseeing the recall of medical devices.

In case the free-sale registration number owner voluntarily revokes the free-sale registration number, the free-sale-number-holder shall send a written request clearly stating the reason for the revocation of the free-sale registration number to the circulation number-issuing agency. After receiving the written request, the circulation number-issuing agency shall withdraw according to the above procedure.

Bao Ngoc

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