Business conditions for the inspection and calibration services  of medical devices

Legal Basis

Decree No. 98/2021/NĐ-CP issued on November 8, 2021: Management of medical devices.

Decree No. 107/2016/NĐ-CP issued on July 1, 2016: Regulations on business conditions, and assessment of compliance.

Decree No. 154/2018/NĐ-CP issued on November 9, 2018: Amendments, supplements, and abolishment of certain regulations on investment and business conditions in the state management of science and technology, and certain regulations on specialized inspections.

Circular No. 05/2022/TT-BYT issued on August 1, 2022: Detailed regulations for implementing some provisions of Decree No. 98/2021/NĐ-CP dated November 8, 2021, of the Government on the management of medical equipment.

List of medical device subject to safety and technical functionality inspection:

Medical devices listed in the publicized list by the Minister of Health must undergo a safety and technical functionality inspection before being put into use, except as stipulated in Article 57 of Decree No. 98/2021/NĐ-CP on the management of medical devices.

For medical devices used for measurement or involving radiation, inspection and calibration must comply with the relevant laws on measurement and atomic energy.

According to the regulations in Circular No. 05/2022/TT-BYT, the list of medical device subject to safety and functionality inspections includes the following devices:

  1. Ventilators.
  2. Anesthesia machines with ventilation.
  3. Electric surgical knives.
  4. Neonatal incubators.
  5. Cardiac defibrillators.
  6. Artificial kidney machines.

Exemption from initial inspection before use for medical device

(According to Article 57, Decree No. 98/2021/NĐ-CP issued on November 8, 2021, on the management of medical device)

Medical device is exempt from initial inspection before use if it falls under one of the following cases:

  1. Medical device with a valid conformity certificate.
  2. Medical device without an import circulation number but used for scientific research or for training purposes, including the instruction of medical device usage, repair, and maintenance.
  3. Medical device without an import circulation number but used for personal healthcare, medical examination and treatment of individuals by the importer, or for special diagnostic needs.
  4. Medical device without an import circulation number but used for trade fairs, exhibitions, displays, and product introductions.

Business conditions for the inspection services of medical device:

(According to Article 57, Decree No. 98/2021/NĐ-CP issued on November 8, 2021, on the management of medical device)

Application for Certificate of Registration for Product Quality Testing Activity

(In accordance with Clause 2, Article 6 of Decree No. 107/2016/ND-CP issued on July 1, 2016: Regulations on business conditions, and assessment of compliance (amended by Clauses 1, 2 of Article 3 of Decree No. 154/2018/ND-CP issued on November 9, 2018))

a) Application form for testing activity:

b) Copy of Business Registration Certificate or Investment Registration Certificate:

c) List of testing personnel and relevant certificates/documents for each tester: Copy of Employment Contract and copy of training certificate for each testing personnel.

d) Documentation proving the testing capability in accordance with the specified requirements, as follows:

In case the testing unit has been recognized by an organization or a foreign-recognized organization as stipulated in Article 25 of this Decree, the testing unit submits a copy of the Recognition Certificate within the recognized scope.

e) Sample Test Result Form:

Procedure for issuing the Certificate of Registration for Testing Activity:

a) Within 5 working days: Upon receiving the application, the receiving authority notifies in writing the reasons for requesting amendments or supplements to the testing organization if the application is incomplete as per required.

b) Within 10 working days: If the application is complete, the competent authority responsible for issuing the Certificate of Registration to the testing organization issues the certificate using the Form No. 10 attached as an Appendix to this Decree.

c) Validity period of the Certificate of Registration: Not exceeding 5 years from the date of issuance.

To receive consultation on document services, registration procedures of medical device, please contact Hotline: 098.546.1894

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