According to regulations under Decree no. 36/2016 ND-CP, Medical equipment shall be classified into 2 groups which are divided into 4 types depending on the possible levels of risks related to the design and production of such medical equipment, in which Group 1 comprises Type A medical equipment which is medical equipment with low level of risks, and Group 2 comprises Type B, C and D medical equipment with higher level of risks. In accordance with these rules, before trading type B, C or D medical equipment, business shall declare its eligibility to trade these medical equipment.
Step 1: Before trading type B, C or D medical equipment, heads of medical equipment trading establishments shall send a declaration of eligibility to trade medical equipment to the Department of Health of the area where the trading headquarters is established;
The declaration of eligibility to trade medical equipment shall consist of:
Step 2: If the declaration is satisfactory, the Department of Health shall issue the establishment with the Note of receipt of the declaration of eligibility to trade medical equipment. If it is not, the Department of Health shall reply with documents.
Step 3: The Department of Health shall publish the following information on its web portal:
The Values Ha Le provides:
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