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"
- 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 Circular, medical 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- Draft guidance on the collection, management and use of charges and fees in the health sector.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- Draft guidance on the management of medical equipment for state health facilities.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
Edited by Jean Ngo
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