February 14, 2020
As of December 2019, there are eight notified bodies based in India, which have been registered with the CDSCO. Previously in May 2018, the CDSCO had approved three notified bodies to operate in India, namely M/s Intertek India Pvt. Ltd, M/s TUV Rheinland India Pvt. Ltd, and M/s TUV Sud South Asia Pvt. Ltd.
As per Rule 13 of the Medical Devices Rules, 2017, an accredited notified body is required to register with the Central Licensing Authority if it intends to carry out audits of a manufacturing site of Class A or Class B medical devices.
Now five more new notified bodies have been issued authorization, bringing the total number to eight. They are as following:
1) M/s Intertek India Pvt. Ltd.
2) M/s TUV Rheinland India Pvt. Ltd.
3) M/s TUV Sud South Asia Pvt. Ltd.
4) M/s Dnv GI Business Assurance India Private Limited
5) M/s BSI Group India Pvt.Ltd.
6) M/s BSCIC CERTIFICATIONS PVT. LTD.
7) M/s TUV INTERCERT SAAR INDIA PRIVATE LIMITED
8) M/s Zenith Quality Assessors Pvt. Ltd