Declaration of eligibility to trade class B, C or D medical equipment

Medical equipment is all types of equipment, implantable supplies, tools, materials, reagents, in vitro calibrators, and software that simultaneously meet specific requirements and are classified into 4 types (A , B, C, D) based on the level of potential risk. According to the law, before purchasing and selling medical equipment, business establishments are responsible for submitting documents declaring eligibility to the Department of Health.

Conditions of establishments trading class B, C, D medical equipment

1. Have at least 01 employee who has at least a college degree in technology, health, pharmacy or medical devices or at least a college degree suitable for the medical devices sold by the establishment;

2. Have storage warehouses and transportation vehicles that meet the following minimum conditions:

a) Storage warehouse:

• Have an area appropriate to the type and quantity of medical equipment being stored,
• Ensure airy, dry, clean, not near sources of pollution,
• Meet other storage requirements of medical equipment according to the instructions for use.

b) The means of transporting medical equipment from the purchasing establishment to the place of delivery is appropriate to the type of medical equipment that the establishment is purchasing.

In case there is no warehouse or means of preserving medical equipment, there must be a contract with a qualified facility to preserve and transport medical equipment.

3. For establishments trading medical equipment containing narcotics and precursors:

a) The person in charge of the profession must have a university degree in medical equipment, medicine, pharmacy, pharmaceutical chemistry or biology.

b) Have a storage warehouse that meets regulations.

c) Have a system to monitor and manage the process of export, import, and inventory of medical equipment containing narcotics and precursors.

For the fastest and most specific answers, Valued Customer can contact Gia Luat; We have many years of experience and are always ready to consult and support you in carrying out procedures in many fields, especially the field of medical equipment business.

Gia Luat's scope of work:

• Consulting on legal regulations related to procedures for declaring eligibility to trade class B, C, D medical equipment:
  • Consulting on notification of changes in enterprise registration (addition of business lines if your business line is not suitable);
  • Consulting on necessary conditions for establishments trading medical equipment of class B, C, D;
  • Consulting on basic cases that do not have to meet the conditions and do not have to carry out procedures for declaring eligibility to trade;
  • Consulting in case the establishment must submit a change notice with documents related to the changed information in the public announcement dossier.
• Guiding Valued Customers to prepare necessary documents and records;
• Checking the legality and validity of documents provided by Valued Customers;
• Preparing documents in accordance with law;
• Representing Valued Customers to submit documents and work with competent authorities;
• Following up and explaining documents at the request of competent authorities (if any);
• Representing Valued Customers to receive results;
• Transfering results and changed records and documents to Valued Customers for internal storage.

We commit to:

• Take responsibility for fully and legally performing the work under the service contract signed with Valued Customers;
• Confidentiality of information and documents provided by Valued Customers.
• Provide the most comprehensive and effective solutions for enterprise operations and management, helping businesses limit risks and ensure compliance with legal regulations.

We believe that our professionalism and carefulness will bring satisfaction and peace of mind when Valued Customers choose Gia Luat.

Thank you very much for your attention to Gia Luat's services.