Circular No. 39/2016/TT-BYT detailing the classification of medical devices

CIRCULAR

DETAILING THE CLASSIFICATION OF MEDICAL DEVICES

Pursuant to Decreedisorderly code or typo; no translatable content provided. No. 63/2012/NĐ-CP dated August 31, 2012 of the Government stipulating the functions, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to Clause 5, Article 5 of Decree No. 36/2016/NĐ-CP dated May 15, 2016 of the Government on medical device management;

At the proposal of the Director of the Medical Equipment and Health Facilities Department,

The Minister of Health issues this Circular detailing the classification of medical devices.

Article 1. Classification of medical devices

1. Medical devices are classified into four categories A, B, C, D according to the rules specified in Appendix I attached hereto.

2. Medical devices are classified into four categories A, B, C, D for one or a group of types of medical devices according to the registration number circulation grouping rules set forth in Appendix II attached hereto.

Article 2. Effectiveness and responsibility for implementation

1. This Circular takes effect from December 15, 2016.

2. Organizations meeting the conditions to carry out medical device classification must apply the rules stipulated in Article 1 of this Circular when conducting such classifications. Any difficulties or issues encountered during implementation should be reported to the Ministry of Health (Medical Equipment and Health Facilities Department) for consideration and resolution.

During the course of implementation, any difficulties or issues should be reported to the Ministry of Health (Medical Equipment and Health Facilities Department) for consideration and resolution./.