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.
Background:
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
Fax: 011-41595460
E-Mail: kamal.gupta@intertek.com
- M/s TUV Rheinland India Pvt. Ltd.
82/A West Wing,
3rd Main Road Electronic City (India) – 560100
Telephone No.: 080- 46498030
Fax: 08046498042
E-Mail: guruprasad.hc@ind.tuv.com
- M/s TUV Sud South Asia Pvt. Ltd.
TUV SUD House
Off Saki Vihar Road, Saki Naka, Andheri (East),
Mumbai-400072
Telephone No.: 022-49035508
Fax: 022-49035508
E-mail: info@tuv-sud.in
Source: Central Drugs Standard Control Organization
