Import of medical devices in Vietnam

Medical devices means the types of equipment, tools, materials and chemicals, including necessary software, which are used separately or in combination with each other in order to serve following human purposes:

 a. Prevention, testing, diagnosis, treatment, mitigation or offset of disease damage;
 b. Check, replace, modify, surgical assistance during examination and treatment;
 c. Support or sustain life;
 d. Control of conception;
 e. Sterilization of health care (not including chemicals, pesticides and disinfectants used in household and health care);
 f. Specialized transportation for health care operations;

Procedure for import of medical devices in Vietnam

The import of medical devices in Vietnam requires ensuring 100% brand new and meeting procedure prescribed by the Ministry of Health.

1. The list of medical devices imported into Vietnam are required import licenses:

 - Diagnostic devices, therapeutic devices and other devices specified in Appendix 1 of Circular 24/2011/TT-BYT dated 21 June.2011 of the Ministry of Health.
 - The other medical devices with new applications of diagnostic and treatment methods and the first time for import into Vietnam.

The procedures for import license of medical devices in Vietnam at the Ministry of Health (via Department of Equipment and Medical Works) upon import shall be implemented in accordance with the provisions of Circular 24/2011/TT-BYT dated 21 June 2011 of the Ministry of Health.

2. Medical devices excluded in the list are not required the import license, but ensuring the following provisions:

 - A certificate of business registration or investment certificate (certified true copy)
 - Records of imported medical equipment as prescribed in point 1.c of Article 5 of Circular 24/2011/TT-BYT.

3. Time limit for granting import license:

 Time limit for granting import license of medical devices in Vietnam within 15 working days from the lodging date of valid and full application file in competent body.

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