Asia
Designation According to the notice published by the Medical Devices Division of CDSCO, the regulating authority registered six notified bodies, authorizing them to perform medical device manufacturing site audits, the appropriate requirement set forth by Medical...
EU MDR/IVDR
According to the MDR requirements, Notified Bodies (NB) should be designated to maintain operations connected with the registration process and perform other supervisory actions. In the course of these medical device regulations, the Spanish regulating authority, the...
EU MDR/IVDR
The British Standards Institution (BSI) United Kingdom (UK) has been officially designated as the first notified body (NB) under the Europe Union’s (EU) new Medical Device Regulation (MDR). This is the first NB to be listed in the European Commission’s New Approach...
Asia
In February, India’s Ministry of Health and Family Welfare released its long-awaited Medical Device Rules, 2017, a 142-page document that lays out every detail of the policy that will regulate all medical devices sold in the country starting in 2018. India...
