Posts tagged with "India"



30. December 2019
The Indian CDSCO now appointed 8 Notified Body for the activities according to the Medical Devices Rules 2017: Intertek, India TÜV Rheinland, India TÜV Süd, India DNV, India BSI, India InterCert Saar, India Zenith Quality Assessors, India Publication: Notice 2019-12-30 The previous publication dated 2019-07-31 just listed 6 Notified bodies.


16. October 2019
The fifth amendment to the Medical devices rules 2017 (may also be called medical devices rules 2019) exempts "testing laboratories of State Governments and Central Government" from the requirements to be accredited by the "National Accreditation Board for Testing and Calibration Laboratories" for a period of two years after this publication.

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. November 2017
The first detailed list of products under the new 2107 regulations including their classification is now available.

31. January 2017
A further step towards fixed medical device registration requirements for India...