CDSCO announces list of Notified Bodies under the Medical Devices Rules, 2017
The Central Drugs Standard Control Organization (“CDSCO”), in a notice dated 4th May, 2018, has announced the notified bodies registered with it to carry out audit of a manufacturing site of Class A or Class B of medical devices.
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 audit of a manufacturing site of Class A or Class B of medical devices.
In this context, CDSCO has issued the following list of notified bodies:
- M/s Intertek India Pvt. Ltd.
E-20, Block B1, Mohan Cooperative,
Industrial Area E-20, Block B1,
Mohan Cooperative, Industrial Area
New Delhi (India) – 110044
Telephone No.: 011-41595475, 9310412823
- M/s TUV Rheinland India Pvt. Ltd.
82/A West Wing,
3rd Main Road Electronic City (India) – 560100
Telephone No.: 080- 46498030
- M/s TUV Sud South Asia Pvt. Ltd.
TUV SUD House
Off Saki Vihar Road, Saki Naka, Andheri (East),
Telephone No.: 022-49035508