Dossier for new issue of medical equipment import Permit applied in Vietnam from November 30, 2015

According to Circular No. 30/2015/TT-BYT of the Ministry of Health of Vietnam, dossier for new issue of medical equipment import Permit includes:

1. The written request for new issue of medical equipment import Permit of the organizations or individuals is under the Form No.01 specified in Annex 2 issued with this Circular.

2. Valid Certificate of free sale of types of imported medical equipment at the time of submission of dossier.

3. The valid ISO 13485 or ISO 9001 quality systems certification (hereafter referred to as ISO Certification) of the manufacturer at the time of dossier submission.

4. The valid Letter of authorization from medical equipment owner to organizations or individuals importing the medical equipment under the Form specified in Annex III issued with this Circular (hereafter referred to as Letter of authorization) at the time of dossier submission.

5. The technical material describing the types of medical equipment in Vietnamese language under the Form No. IV issued with this Circular.

6. Catalogue describing the functions and technical parameters of types of imported medical equipment.

7. The clinical assessment material and manual of the owner or manufacturer for the medical equipment specified in section 49 of Annex I issued with this Circular.

8. Report on result of import of medical equipment by the time of dossier submission for new issue of medical equipment import Permit in case where the import Permit has expired without renewal as stipulated in Clause 2, Article 5 of this Circular. The report on the result of import of medical equipment is under the Form specified in Annex 6 issued with this Circular.

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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