Service on Declaration of Eligibility to Trade Type B, C, D Medical Equipment

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.

Service description:

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:

• A declaration form of eligibility to trade medical equipment using the form No. 07 specified in Annex I enclosed with this Decree;
• A list of employees using the form specified in Annex II enclosed with this Decree;
• Papers proving that the storage facilities and vehicles are conformable to requirements specified in clauses 3 and 4 Article 13 of this Decree. Such papers shall be certified by the establishment declaring the eligibility to trade medical equipment.

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:

• Name and address of the establishment trading medical equipment
• The declaration of eligibility to trade medical equipment.

The Values Ha Le provides:

• Consultancy on declaration of eligibility to trade medical equipment;
• Consultancy on preparations of documents and information to complete declaration;
• Compose and prepare related documents;
• Represent business to conduct procedures of declaration of eligibility to trade medical equipment at competent authorities;
• Discuss and provide information to customers in the process of declaration;

Please contact for further consultancy and detailed quotation!