CIRCULAR 39/2016/TT-BYT: CLASSIFICATION OF MEDICAL DEVICES

CIRCULAR

CLASSIFICATION OF MEDICAL DEVICES

Pursuant to the Government’s Decree No. 63/2012/NĐ-CP dated August 31, 2012 defining the functions, tasks, powers and organizational structure of the Ministry of Health;

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

At the request of Director of Health Device and Work Department,

The Minister of Health promulgated a Circular on classification of medical devices.

Article 1. Classification of medical devices

1. Medical devices are classified into 4 classes (A, B, C, D) according to the rules specified in Appendix I enclosed herewith.
2. Medical devices are classified into 4 classes (A, B, C, D) according to the grouping principles specified in Appendix II enclosed herewith.

Article 2. Effect and responsibility for implementation

1. This Circular comes into force from December 15, 2016.
2. Organizations qualified for classification of medical devices shall apply the rules mentioned in Article 1 of this Circular.

Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health for consideration./.