Vietnam: 06 cases of revocation of medical equipment import Permit

20:57, 15/10/2015

Medical equipment is the types of equipment, tool, material and in-vitro diagnosis chemical and software used separately or combined with each other as indicated by the owner to serve people for one or a lot of purposes.

thu hồi giấy phép nhập khẩu trang thiết bị y tế, 30/2015/TT-BYT

According to Circular No. 30/2015/TT-BYT of the Ministry of Health of Vietnam, cases of revocation of medical equipment import Permit are specified as follows:

- The importing unit forges the dossier for issue of medical equipment import Permit;

- Organizations or individuals modifies or erases for change of content of medical equipment import Permit;

- The importing unit has terminated its operation or no longer authorized by the owner or medical equipment manufacturer without transfer of import right to the replacing organization;

- The medical equipment circulated in the market has defects causing adverse effects to the health of users with impossible remedies.

- The medical equipment import Permit has been issued beyond the authority or with improper dossier or procedure as prescribed by this Circular.

- The medical equipment whose circulation duration is over according to the notice of the manufacturer or owner of medical equipment or competent authorities.

The procedures for revocation of medical equipment import Permit are specified as follows:

- During the examination or inspection, if detecting any breach specified in Clause 1 of this Article, the unit performing the examination or inspection shall make a record and send it to the Ministry of Health;

- Within 05 working days after receiving the record specified under Point a of this Clause, the Ministry shall review and decide the revocation of medical equipment import Permit. The revocation Decision is posted on the website of the Ministry of Health and sent to the customs authorities and organizations or individuals responsible for import.

After having the revocation Decision of medical equipment import Permit, the importing unit shall revoke the imported medical equipment specified in the revocation Decision and stop the import of such equipment.

View more details at Circular No. 30/2015/TT-BYT of the Ministry of Health of Vietnam, effective from November 30, 2015.

Le Hai

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