Requirements for operation and issue of Licenses for Tissue Bank Operation in Vietnam

09:03, 04/08/2016

According to Decree No. 118/2016/NĐ-CP of Vietnam’s Government amending Decree No. 56/2008/NĐ-CP on organization and operation of tissue banks and National Coordination Center for Human Organ Transplantation, requirements for operation and issue of Licenses for Tissue Bank Operation include:

- It has the Establishment Decision or be named in the competent authority’s document on organizational structure of medical facilities (for State-owned tissue banks) or Enterprise Certificate (for private tissue banks).

- It has at least: an operating room, a laboratory, an administrative office, record-keeping room and consulting room.

- Minimum personnel:

+ A tissue bank professional manager who meets all requirements in Clause 4, Article 35 of the Law on Donation, removal and transplantation of human tissues and organs, and body donation 2006 of Vietnam;

+ 01 doctor or lab scientist having the medicine practice certificate;

+ 02 medical technicians or nurses having at least an associate degree in medicine or medicine practice certificate;

+ 01 office administrator.

- It has all of the equipment on the List prescribed in Annex I enclosed with Decree No. 118/2016/NĐ-CP of Vietnam’s Government.

Decree No. 118/2016/NĐ-CP of Vietnam’s Government takes effect from September 15, 2016.

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