30. September 2019

The update of the classification rules published as "ҚР ДСМ-129" [Link in Russian] by the Ministry of Health in Kazakhstan modifies the existing regulation 764" on the Regulations for the Classification for the Safety of Medical Devices and Medical Equipment" dated 2009-11-24. Kazakhstan continues to follow the four classes concept with Classes I, IIa, IIb and III based on 33 rules for medical devices plus rules 34-43 for IVD Products.

15. May 2019

The Indian regulatory body: Drugs Controller General (India) Directorate General of Health Services FDA Bhawan, Kotla Road, New Delhi. published on the CDSCO Website a new classification list today: link to the list

01. December 2018

Australian TGA reclassifies the surgical mesh products from IIb to Class III

07. December 2017

The Borderline Working group chaired by the EU Commission published the updated Version 1.18 of the "MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES". The document is intended to act as a guidance for the interpretation of the MDD and IVD. The new paragraphs introduced by the update are identified by the pictogram "New" and include the products: Products intended to reduce the effect of alcohol Radiation shields D-mannose for the prevention of...