Webinar from NABCB – Dec 20, 2021 – 11 AM – 1 PM
PROGRAM ANNOUNCEMENT FROM NABCB :
NABCB is pleased to announce a Webinar on NABCB Accreditation for Inspection Body (ISO/IEC 17020:2012) for all stakeholders including Industries and Government Bodies on 20 December 2021,11:00hrs to 13:00hrs.
Registration Link: https://lnkd.in/dHnbtEci
It has been observed that Notified body performing QMS audit for the Class A and Class B medical devices manufacturing unit in India and NABCB is the technical supervisor / controlling authority of such Notified Body . We all know that classification of medical devices all over the world are based on Risk involved with the device . All over world most risk based devices are audited by the third party conformity assessment body (NB). It has also mentioned in 21CFR 820 that Class A medical devices manufacturer can manufacture devices based on self audit . Conformity Assessment is not required . Surprisingly , in India just opposite activities are encouraging . Here under the Medical Device Rule 2017 , Class A devices and Class B devices are scrutinizing / auditing by the Conformity Assessment Body . Class C Medical Devices and Class D devices ( which are most invasive in nature ) are not audited by Notified body . NABCB should take appropriate step to uniform this approach . Medical Device Regulation is new in India . Medical Device Rule 2017 are framed under the Drugs & Cosmetics Act 1940 . NABCB is the only technical body to rectify this highly sensitive matter .
India is not yet fit to have self declaration because sufficient deterrence is not there. What happened in PPEs last year where with one sample tested, manufacturers were approved and trusted to deliver quality but failed is well known. In case of cl C and D regulator himself is auditing directly. No doubt our system is more stringent but there are legitimate reasons for it.