CDSCO announces list of Notified Bodies under the Medical Devices Rules, 2017

CDSCO announces list of Notified Bodies under the Medical Devices Rules, 2017

May 9, 2018 Industry Specific 0

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

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