Ministry of Health amends 5 administrative procedures in the field of medical equipment

Accordingly, the Ministry of Health promulgates together with this Decision 5 administrative procedures in the field of medical equipment amended and supplemented in Decree No. 96/2023/ND-CP dated December 30, 2023 of the Government detailing a number of articles of the Law on Medical Examination and Treatment under the management scope of the Ministry of Health. These are the procedures: Issuing new circulation numbers for medical equipment of types C, D that have corresponding national technical regulations; Issuing new circulation numbers for medical equipment of types C, D that are measuring instruments subject to model approval according to the provisions of the law on measurement; Issuing new circulation numbers for medical equipment of types C, D in cases of rapid issuance; Issuing urgent circulation numbers for medical equipment of types C, D in urgent situations serving disease prevention and control; Issuing new circulation numbers for other medical equipment of types C, D.

Previously, regarding the health sector, the Ministry of Health issued a document consolidating Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government regulating the management of medical equipment, Decree No. 07/2023/ND-CP dated March 3, 2023 of the Government amending and supplementing a number of articles of Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government regulating the management of medical equipment and Decree No. 96/2023/ND-CP dated December 30, 2023 of the Government detailing a number of articles of the Law on Medical Examination and Treatment.

This document regulates the management of medical equipment including: classification of medical equipment; production, clinical research, circulation, purchase, sale, export, import, provision of medical equipment services; information, advertising of medical equipment; management of medical equipment prices and management and use of medical equipment at medical facilities.

Medical devices are classified into four categories based on the level of potential risk associated with the technical design and manufacture of the medical devices: Class A medical devices are low-risk medical devices; Class B medical devices are low-medium risk medical devices; Class C medical devices are high-medium risk medical devices; Class D medical devices are high-risk medical devices.
The Ministry of Health stated that the classification of medical devices must be based on the classification rules of risk levels. Medical devices have only one intended use but that intended use can be classified into two or more different risk levels, then the classification according to the highest risk level shall be applied.

Medical devices have multiple uses and each use has a different level of risk, so the classification according to the highest level of risk applies.

Where a medical device is intended to be used in combination with another medical device, each medical device must be classified separately according to its risk level.

In the case of in vitro diagnostic medical devices, the equipment, equipment systems involved in the testing process and the reagents, standards, calibrators, and control materials are classified with separate risk levels, but the classification results must be based on the highest risk level of the end use of the combined medical device as a whole. In vitro diagnostic medical devices are other products involved in or supporting the testing process and are classified with separate risk levels.

The Minister of Health shall specify in detail the classification of medical equipment to ensure compliance with international treaties on the classification of medical equipment of the Association of Southeast Asian Nations of which Vietnam is a member.

Classification of medical devices must be performed by a classification facility that is the facility that publishes the applicable standards or registers for circulation.