Procedure for application for declaration of eligibility for medical device trading

Medical Devices (“MD”) have an important position and role in the health system. The reason for this affirmation is that MD can support enhancing the quality of diagnosis of the cause of the disease, thereby supporting doctors to orient the treatment, prevention, and rehabilitation regimen for patients. Not only that but this also helps doctors to determine more accurately the drugs/medicines to be used to treat patients to shorten the treatment time as much as possible, improve treatment efficiency, and increase safety for patients. Some types of MD also have the function of supporting doctors in caring for and treating patients in order to reduce the word load from humans.  

Due to its important and great influence on the health of patients above as well as users of medical devices, the competent state agencies of Vietnam have issued a strict legal framework in the management of activities related to medical devices. Regarding this matter, the management of medical equipment purchase and sale activities is also provided. Specifically, point a, Clause 2, Article 41 of Decree 98/2021/ND-CP amended by Decree 96/2023/ND-CP stipulates that “Before buying and selling medical devices, the traders are responsible for submitting a dossier of announcement to the Department of Health where the trading location is located”. The dossier of announcement here is understood as the dossier of declaration of eligibility for trading in MD according to regulations. The trading unit must carry out the procedures for announcing eligibility for MD trading  

However, not all classes of MD are required to carry out the above procedures. Accordingly, only the traders that buy and sell the MD of class B, C and D are subject to this announcement procedure.  

Regarding the trading activities of Class B, C, and D medical devices, the traders engaging in the trading of these categories of medical devices should take note of the following points: 

Firstly: Must compliance with the required conditions for trading medical devices, including: 

  1. Must satisfy the personnel requirements, including having at least one technical staff member with a college-level qualification in engineering, medicine, pharmacy, chemistry, biology, or medical device engineering; or a college-level qualification or higher in a discipline relevant to the type of medical device being traded. 
  2. Must have a storage facility (warehouse) with an appropriate area, suitable for the classes and quantities of medical devices being stored. The storage area must be well-ventilated, dry, clean, and not located near sources of contamination. It must also comply with any additional storage requirements specified in the instructions for use of the medical devices. 
  3. Must have appropriate means of transportation for delivering medical devices from the trading facility to the place of delivery, suitable for the classes of medical device being traded. In cases where the entity does not have its own storage facility or transportation means, it must have a contract with a qualified organization capable of storing and transporting medical devices. 
  4. For the establishments containing narcotics and precursors:
    The chief technician must hold a bachelor’s degree in medical devices, medicine, pharmacy, pharmaceutical chemistry or biology. The establishment must have a storage facility that complies with domestic regulations on controlling activities related to narcotics. There must also be a system to monitor and manage the process of import, export, and inventory of medical devices containing narcotics and precursors.

Secondly: Submitting the dossier for declaring eligibility to trade medical devices to the Competent state authority. 

1. The dossier of declaration of eligibility shall be made in 01 set and must contain documents such as:

  • The declaration of eligibility for medical device trading; 
  • A personnel list; 
  • Documents proving that the warehouse and vehicle satisfy the requirements. These documents must be certified by the applicant; 
  • Documents proving that the warehouse and inventory monitoring system for medical devices containing narcotic substances and precursors comply with the requirements. Such documents shall be certified by the establishment making declaration of eligibility for trading in medical devices that contain narcotic substances and precursors;

2. Location of submission: The Department of Health of province where the trading establishment is located. 

3. Timeline: After submitting all valid required documents to the Competent state authority.

Note: If MD belongs to classes B, C and D but which is listed on the list of MD that is bought and sold as ordinary goods, when buying and selling, it is not required to meet the above conditions and does not have to carry out the procedures for announcing eligibility for trading as prescribed. However, the traders still are required to meet the conditions for preservation, storage and transportation according to the regulations of the owner of the medical device. 

Above are some of the information that Apolat Legal would like to provides to Clients related to the conditions for trading MD in classes B, C, D and the procedures for announcing eligibility for trading them in accordance with current laws for your reference. 

Related posts

  1. Key points when engaging in activities which relating to medical device
  2. Conditions of business for some of the necessary medical equipment goods

Disclaimers:

This article is for general information purposes only and is not intended to provide any legal advice for any particular case. The legal provisions referenced in the content are in effect at the time of publication but may have expired at the time you read the content. We therefore advise that you always consult a professional consultant before applying any content.

For issues related to the content or intellectual property rights of the article, please email cs@apolatlegal.vn.

Apolat Legal is a law firm in Vietnam with experience and capacity to provide consulting services related to Business and Investment and contact our team of lawyers in Vietnam via email info@apolatlegal.com.



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