Requirements to be Satisfied by Organizations Conducting Classification of Medical Equipment in Vietnam

Requirements to be Satisfied by Organizations Conducting Classification of Medical Equipment in Vietnam.

** Decree 36/2016/NĐ-CP on Medical Equipment Management:

- The classification of medical equipment must be conducted by an organization who satisfy the conditions specified in Article 7 of this Decree.

- The organization conducting the classification of medical equipment must take legal responsibility for the classification of such medical equipment.

- If there is difference in the classification of medical equipment, such classification shall be decided by the Ministry of Health.

** Requirements from the organization:

- Legally established as prescribed by law;

- Have a qualified medical equipment-classifying employees, who must satisfy all the following pre-requisites in Clause 2 of Decree 36, as follows:

+ Having at least a bachelor’s degree in technology or medicine/pharmacy;

+ Having at least 24 months’ experience of working in the field of medical equipment technologies at hospitals, medical facilities with beds, training institutions specializing in medical equipment, facilities researching on medical equipment, establishments producing medical equipment, organizations conducting classification of medical equipment, or agencies managing medical equipment (hereinafter referred to as “medical equipment facilities”);

+ Have taken a test and have been recognized by a training institution as capable of classifying medical equipment that is according to the training program issued by the Ministry of Health.

- Such organization shall conduct the classification of medical equipment only when it has obtained the Receipt Note (for the Declaration of Eligibility to Classify Medical Equipment) from the Ministry of Health according to provisions of Clause 1-b, Article 9 of this Decree.



Edited by Jean Ngo