Consultation – Announcement of eligibility For trading class BCD Medical devices

Consultation – Announcement of eligibility For trading class BCD Medical devices

CONSULTATION – ANNOUNCEMENT OF ELIGIBILITY FOR TRADING
CLASS B, C, D MEDICAL DEVICES

Medical devices of Class B, C, D are classified with low, medium-high, and high levels of risk, respectively. Therefore, the trading of Class BCD medical devices must also comply with legal regulations by going through the procedure of announcing the eligibility for trading medical devices (except for some medical devices traded as regular goods according to the regulations of the Ministry of Health).

Legal basis

– Decree 98/2021/ND-CP issued on November 8, 2021: On the management of medical devices.

– Circular 10/2023/TT-BYT  issued on May 11, 2023: Amending and supplementing some provisions of Circular 19/2021/TT-BYT dated November 16, 2021, of the Minister of Health regulating document templates, and reports implementing Decree 98/2021/ND-CP dated November 8, 2021, of the Government on the management of medical devices.

– Circular 19/2021/TT-BYT  issued on November 16, 2021: Regulating document templates and reports implementing Decree 98/2021/ND-CP dated November 8, 2021, of the Government on the management of medical devices.

– Decree 07/2023/ND-CP dated March 3, 2023: Amending and supplementing some provisions of Decree 98/2021/ND-CP dated November 8, 2021, of the Government on the management of medical devices.

– Circular 05/2022/TT-BYT  issued on August 1, 2022: Detailing the implementation of some provisions of Decree 98/2021/ND-CP dated November 8, 2021, of the Government on the management of medical devices.

Conditions for Trading Medical Devices of Class B, C, D

1. Have at least 01 technical staff specializing in medicine, pharmacy, chemistry, biology, medical equipment, or trained in this relevant field with a college degree or higher.

2. Have storage facilities and transportation means that meet the following minimum conditions:

a) Storage facility:

– Adequate storage space for each type and quantity of medical devices.

– Storage in a well-ventilated, dry, clean area, away from sources of pollution.

– Compliance with other storage requirements for medical devices according to the instructions for use

b) Transportation means for medical equipment from the place of purchase to the delivery location suitable for the type of medical device (in cases where there is no warehouse, the means of storing medical devices must have a contract with a facility with sufficient capacity to store and transport medical devices).

3. For establishments trading medical devices containing narcotic drugs and precursors:

a) The professional in charge must have a university degree in medicine, pharmacy, pharmaceutical chemistry, or biology.

b) Have a storage facility that meets the regulations on guiding the control of activities related to drugs within the country.

c) Have a system to monitor the process of importing, exporting, and inventorying medical devices containing narcotic drugs and precursors.

Documents to Prepare for Announcing Eligibility for Trading Medical Devices of Class B, C, D

a) Document announcing eligibility for trading medical devices.

b) List of medical devices.

b) Declaration of personnel.

c) Documents proving storage and transportation capabilities of medical devices that meet the specified requirements (these documents must be confirmed by the facility announcing eligibility for trading).

d) Documents proving storage and monitoring system for the process of importing, exporting, and inventorying medical devices containing narcotic drugs and precursors, meeting the requirements (these documents must be confirmed by the facility announcing eligibility for trading in medical devices containing narcotic drugs and precursors).

Annoucement of eligibility for trading class B, C, D medical devices

Announcement of eligibility for trading class B, C, D medical devices

List of Medical Devices of Class B, C, D That Can Be Traded as Regular Goods According to the Regulations of the Ministry of Health

  1. Personal blood pressure monitors.
  2. Finger-clip type pulse oximeters (SpO2).
  3. Baby nasal aspirators.
  4. Electronic thermometers, infrared thermometers.
  5. Personal blood glucose monitoring devices: blood glucose meters, lancets, test strips, blood collection needles, standard solutions, control solutions.
  6. Steam inhalers.
  7. Personal medical bandages.
  8. Artificial tears classified as medical devices.
  9. Condoms.
  10. Non-hormonal contraceptive films.
  11. Lubricants classified as medical devices for vaginal use.
  12. Electric hot and cold packs.
  13. In vitro diagnostic medical devices for self-testing of Class B.
  14. In vitro diagnostic medical devices for self-testing for HIV, SARS-CoV-2.

Procedure and Process for Announcing Eligibility for Trading Medical Devices of Class B, C, D

a) Before trading medical devices, the trading establishment is responsible for submitting the announcement file to the Department of Health where the trading place is located.

b) Upon receiving the documentation (including the confirmation of fee payment as required), the Department of Health in the area where the trading establishment is headquartered will publicly post information and the announcement file of eligibility for trading medical devices on the electronic information portal for the management of medical devices.

c) During the operation, the trading establishment is responsible for drafting a notification of changes, along with related documents regarding the changes, and updating these documents in the publicly disclosed file on the electronic information portal for the management of medical devices within a period of 03 working days (from the date of changes to the information in the announcement file).

For consultation on MEDGATE’s registration and import-export services, please contact us at the hotline 098.546.1894 or send a message via our fan page for immediate assistance.