Food and Drugs Administration, (FDA) Haryana, India. |
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Last Updated on January 3, 2024 by The Health Master
Download the list of Notifies Bodies
The notified bodies registered with CDSCO under provisions Medical Devices Rules, 2017 to carry out audit of manufacturing site under the provisions of said rules.
In this connection, following Notified Bodies have been registered with CDSCO:
List of notified Bodies
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 Electronic City (India) – 560100.
Telephone No.: 080-46498030 Fax: 080 4649 8042.
E-Mail: guruprasad.hc@ind.tuv.com
Registration Certificate No. RC/NB-000002
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, BKC, LBS Road, Kurla West, Mumbai-400070 (India).
Telephone No.: 022-61768909 Fax: 022-61768950.
E-Mail: joher.jerwalla@dnvgl.com
Registration Certificate No. RC/NB-000004
5. M/s BSCIC Certification Pvt. Ltd.
Flat No. 6, Shiv Shakti, GH-15, Sec-21C, Part-3, Faridabad-121001 (India),
Telephone No: 01294175513, Fax: 01294175513
Email: compliane4@bsc-icc.com
Registration Certificate No. RC/NB-000006
6. M/s MTIC Intercert India Pvt. Ltd.
No 122/1, 3rd Main Road, Margosa Road, Malleswaram, Bangalore-560003 (India).
Telephone No: 918041285610, Fax: 918041285610
Email: DRUMAKANTDUBEY@TUVINTERCERT.IN
Registration Certificate No. RC/NB-000007
7. M/s Zenith Quality Assessors Pvt. Ltd.
No. 306, 4th Floor, Sai Apex, Viman Nagar, Pune-411014 (India),
Telephone No: 20-41322042, 41322043, Fax: 20-41322042, 41322043
Email: pradyut@zenith-worldwide.com
Registration Certificate No. RC/NB-000008
8. M/s International Certification Services Pvt. Ltd.
22/23, Goodwill Premises, Swastik Estate, 178 CST Road, Kalina, Santacruz East, Mumbai-400098 (India)
Telephone No: 02242200900, 02226507777, Fax: 02242200900 02226507777
Email: info@icspl.org/info@icsasian.com
Registration Certificate No. RC/NB-000009
9. M/s TUV India Private Limited
801, Raheja Plaza, LBS Road, Ghatkopar West. MUMBAI-400086 (India),
Telephone No: 22-66477000, Fax: 22-66477000
Email: rahulnayak@tuv-nord.com
Registration Certificate No. RC/NB-0000101
10. M/s ACM EMB Pvt. Ltd.
210,2ND FIR Syndicate House Old Rohtak Rd, Inderlok, New Delhi-110035 (India)
Telephone No: 09029527001, Fax: 09029527001
Email: info@acmert.in
Registration Certificate No. RC/NB-000011
11. M/s IRCLASS Systems and Solutions Private Limited
52 A, Adi Shankaracharya Marg, Powai, Mumbai-400072 (India)
Telephone No: 09167178393, Fax: 09167178393
Email: shasinath.mishra@irclass.org
Registration Certificate No. RC/NB-000012
12. M/s UL India Pvt. Ltd
24, Kalyani Block, 3rd Floor EPIP Zone, Whitefield Bangalore, Bangalore-560066 (India)
Telephone No.: 08041384400, Fax:08041384400
Registration Certificate No. RC/NB-000013
13. M/s Quality Austria Central Asia Private Limited
Second Floor,, Block 201, Tower C ATS Banquets,
Noida-201301 (India)
Telephone No.: 08685831284, Fax:08685831284
Registration Certificate No. RC/NB-000014
Source: CDSCO Website
List of Notified Bodies: Download
Central Govt. time to time notifies Notified Bodies for the inspection for Medical Devices. For more details click below links:
List of 13 Notified Bodies registered with CDSCO under MDR 2017 as on 03-04-2023
List of 13 Notified Bodies registered with CDSCO under MDR 2017 as on 03-04-2023
List of Notified Bodies (13) registered with CDSCO under MDR, 2017 as on 09-03-2023
List-of-Notified-Bodies-13-registered-with-CDSCO-under-MDR-2017-as-on-09-03-2023
List of Notified Bodies registered with CDSCO under MDR, 2017 as on 25-08-2022
DCGI dt 11-11-2021 – List of Notified Bodies registered with CDSCO under MDR-2017
DCGI-dt-11-11-2021-List-of-Notified-Bodies-registered-with-CDSCO-under-MDR-2017
Central Govt. has notified 8 Notified Bodies on 30-12-2019 for inspection for grant of manufacturing of Medical Devices Category B. For more details click below:
Central Govt. has notified 6 Notified Bodies on 31-07-2019 for inspection for grant of manufacturing of Medical Devices Category B. For more details click below:
Central Govt. has notified 6 Notified Bodies on 31-07-2019 for inspection for grant of manufacturing of Medical Devices Category B. For more details click below:
Procedure to obtain license for manufacturing of Medical Devices
Procedure for registration of Medical Devices: CDSCO
Registration for sale of Medical Devices: Procedure and conditions
Latest Notifications: Medical Devices
Classifications of Medical Devices under the provisions of MDR 2017
Notified Bodies for Medical Devices
Medical Device Testing Laboratories (MDTLs)
FAQs on Medical Devices Rules, 2017
FAQs – on Blood Pressure Monitoring Devices
FAQs – on Blood Bags and its Testing
NABL 126: Specific criteria for calibration of Medical Devices
Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
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