Regulations on Medical Device Management in Vietnam

Regulations on medical device management in Vietnam

Regulations on Medical Device in Vietnam

** Decree 36/2016/NĐ-CP: "Medical Equipment Management" dated May 15, 2016.

This Decree encompasses medical equipment classification, manufacture, label information, free sale and provision of services related to medical equipment, and the management and use of medical equipment in a medical facility.

This Decree was implemented on all stakeholders on July 01, 2016.

** Circular 30/2015/TT-BYT: "Import of Medical Equipment" dated October 12, 2015. 

- This Circular defines the authority, dossiers and procedures for issuing an Import Permit for a new medical equipment as listed in the Annex 1 of this Circular.

- This Circular was applied to all stakeholders by November 30, 2015.

** Circular 39/2016/TT-BYT: "Classification of Medical Equipment" dated October 28, 2016.

Provides detailed description and classification of medical equipment.  As per Appendix I of this Circularmedical devices are categorized into 4 classes: A, B, C & D.

- As per Appendix II of this Circular, medical devices are grouped into 4 classes: A, B, C & D

- This Circular came into force on December 15, 2016.

** Official Letter 1275/BYT-TB-CT dated March 11, 2016:

- States the strict compliance to the provisions of Circular No. 30/2015/TT-BYT regarding customs procedure.

- The Ministry of Health also issued a guidance note regarding software use together with this Letter on its online portal.

** Related Drafts:

- Draft list of countries whose medical equipment classification results will be acknowledged by Vietnam authorities.

- Draft guidance on the collection, management and use of charges and fees in the health sector.

- Draft list of measuring devices that must have an approved sample, test and calibration.

- Draft national standards to be used in the inspection and quality check of measuring devices and radiation equipment.

- Draft guidance on the management of medical equipment for state health facilities.

Edited by Jean Ngo

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