8 notified bodies registered now under MDR 2017

8 notified bodies registered now with Central Drugs Standard Control Organisation (CDSCO) under Medical Devices Rules 2017 (MDR 2017) to audit

489
Documentation notified body
Picture: Pixabay
2 min. read

8 notified bodies registered now with CDSCO under MDR 2017

Medical Devices Rules 2017 has already been published vide G.S.R 78(E) dated 31.01.2017 under Drugs and cosmetics Act to regulate the manufacture, import, sale and distribution of the medical devices and said rules are effective from 01.01.2018.

The notified bodies registered with Central Drugs Standard Control Organisation (CDSCO) under Medical Devices Rules 2017 (MDR 2017) to carry out audit of manufacturing site under the provisions of said rules.

Also read:
1. License for Manufacturing and Import of Medical Devices
2. Risk Management of Medical Devices – ISO: 14971

Two more notified bodies have been recently registered with CDSCO
So, now as on date 8 notified bodies registered with CDSCO under MDR 2017

List of 8 notified Bodies registered is as under

  1. 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
    Registration Certificate No. RC/NB-000001

2. M/s  TUV Rheinland India Pvt. Ltd.
82/A West Wing, 3rd Main Road 82/A West Wing,
3rd Main Road Electronic City(India)-560100
Telephone No.: 080-46498030 Fax: 080-46498042
E.Mail: guruprasad.hc@ind.tuv.com
Registration Certificate No. RC/NB-000002

Also read: Effective date for medical devices extended

3. 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
Registration Certificate No. RC/NB-000003

4. M/s Dnv GI Business Assurance India Private Limited
Equinox Business Park, Tower 3, 6th Floor, BKG, LBS Road,
Kurla West, Mumbai-400070(India),
Telephone No.: 022-61768909 Fax: 022-61768950 Fax: 022-61768950
E.Mail: JOHER.JERWALLA@DNVGL.Com
Registration Certificate No. RC/NB-000004

Also read: NITI Aayog consults stakeholders on medical devices bill

5. M/s  BSI Group India Pvt. Ltd.
    The Mira Corporate Suites, Plot No. 1&2,
Ishwar Nagar Delhi – 110065(India)
Telephone No.- 11-26929000, Fax: 26929000
Registration Certificate No. RC/NB-000005

6. M/s  BSCIC Certifications Pvt. Ltd.
Flat No. 6,Shiv Shakti, GH-15,Sec-21C, Part-3,
Faridabad-121001(India),
Telephone No. 01294175513, Fax. – 01294175513
Registration Certificate No. RC/NB-000006

Also read: Ways to keep medical devices pathogen free

7. M/s  TUV Intercert Saar India Private Limited
No.122/1, 3rd Main Road,Margosa Road,
Malleswaram, Bangalore-560003(India),
Telephone No.- 918041285610, Fax: 918041285610
Registration Certificate No. RC/NB-000007

8. M/s  Zenith Quality Assessors Pvt. Ltd.
No. 306, 4th Floor, Sai Apex, Viman Nagar,
Pune-0411014(India),
Telephone No.- 20-41322042, 41322043, Fax: 20-41322042, 41322043
Registration Certificate No. RC/NB-000008

To download CDSCO notice regarding Notified Bodies, click here

To explore more about medical devices, click here

LEAVE A REPLY

Please enter your comment!
Please enter your name here