**Executive Summary:**
This notice from the Central Drugs Standard Control Organisation (CDSCO), dated April 5, 2023, lists the Notified Bodies registered with CDSCO under the Medical Devices Rules (MDR), 2017. These bodies are authorized to audit manufacturing sites as per the MDR, 2017, which regulates the manufacture, import, sale, and distribution of medical devices. The rules are effective from January 1, 2018.
**Key Points / Main Content:**
* **Medical Device Rules, 2017:**
* Published vide G.S.R. 78 E dated 31.01.2017 under Drugs and Cosmetic Act.
* Regulates the manufacture, import, sale, and distribution of medical devices.
* Effective from 01.01.2018.
* **Notified Bodies Registered with CDSCO:**
* Authorized to conduct audits of manufacturing sites under the Medical Devices Rules, 2017.
* The notice lists 14 Notified Bodies registered with CDSCO, including their addresses, contact details, and Registration Certificate Numbers (RCNB000001 to RCNB000014).
**Impact Analysis:**
**Manufacturers of Medical Devices:**
* Impact: Must ensure compliance with Medical Devices Rules, 2017 and may need to undergo audits by the listed Notified Bodies.
* Action Required: Be aware of the notified bodies, ensure compliance, and coordinate with a listed Notified Body for audits as required.
**Notified Bodies:**
* Impact: Listed as registered bodies authorized to conduct audits under the Medical Devices Rules, 2017.
* Action Required: Conduct audits of manufacturing sites as per the provisions of the Medical Devices Rules, 2017.
**CDSCO:**
* Impact: Responsible for the regulation of medical devices and the registration of Notified Bodies.
* Action Required: Maintain the list of Notified Bodies and ensure compliance with the Medical Devices Rules, 2017.
**IT Cell:**
* Impact: Responsible for making the information public.
* Action Required: Upload the information on the CDSCO website.
Key Entities Referenced
Central Drugs Standard Control Organisation: A national regulatory body for pharmaceuticals and medical devices in India.
Medical Devices Rules, 2017: A set of regulations governing the manufacture, import, sale, and distribution of medical devices in India.
CDSCO: An abbreviation of Central Drugs Standard Control Organisation.
Drugs and Cosmetic Act: The primary legislation in India regulating drugs and cosmetics.
Intertek India Pvt. Ltd.: A notified body registered with CDSCO under Medical Devices Rules, 2017.
TUV Rheinland India Pvt. Ltd: A notified body registered with CDSCO under Medical Devices Rules, 2017.
TUV Sud South Asia Pvt. Ltd: A notified body registered with CDSCO under Medical Devices Rules, 2017.
Rajeev Singh Raghuvanshi: Drugs Controller General of India
File No. 29/Misc/3/2017-DC (288)
Government of India
Ministry of Health & Family Welfare
Directorate General of Health Services
Central Drugs Standard Control Organisation
(Medical Devices Division)
Date: 0 5 APR 2023
NOTICE
Subject: List of Notified Bodies registered with CDSCO under MDR, 2017-
regarding
As you are aware that Medical Devices Rules, 2017, has already been published
vide G.S.R. 78 (E) dated 31.01.2017 under Drugs and Cosmetic 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 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:
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 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),
Page 1 of 3Telephone No.: 022-61768909 Fax: 022-61768950
E-Mail: JOHER.JERWALLA@DNVGL.COM
Registration Certificate No. RC/NB-000004
5. 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
6. M/s, MTIC INTERCERT INDIA PRIVATE LIMITED
No 122/1, 3rd Main Road, Margosa Road,
Malleswaram, Bangalore-560003 (India),
Telephone No: 918041285610, Fax: 918041285610
Email: drumakantdubey@mtic-group.in
Registration Certificate No. RC/NB-000007
7. Mls, Zenith Quality Assessors Pvt. Ltd.
No. 306, 4" Floor, Sai Apex, Viman Nagar,
Pune-411014 (India),
Telephone No: 20-41322042, 41322043, Fax: 20-41322042, 41322043
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
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
Registration Certificate No. RC/NB-000010
10. M/s ACM EMB Private Limited
210, 2" FIR Syndicate House, Old Rohtak Road,
Inderlok, New Delhi — 110035 (India)
Telephone No.: 09029527001, Fax: 0902957001
Email: INFO@ACMCERT.IN
Registration Certificate No. RC/NB-000011
11. M/s IRCLASS Systems and Solutions Private Limited,
52A, Adi Shankaracharya Marg, Powai,
Mumbai — 400072 (India)
Telephone No.: 09167178393, Fax: 09167178393
Email: SHASHINATH.MISHRA@IRCLASS.ORG
Registration Certificate No. RC/NB-000012
Page 2 of 312. M/s UL India Pvt. Ltd.,
24, Kalyani Block, 3 Floor EPIP Zone,
Whitefield, 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 BOUQUETS,
Noida - 201301 (India)
Telephone No.: 08685831284, Fax: 08685831284
Email: DIGVIJAY.SINGH@QACAMAIL.COM
Registration Certificate No. RC/NB-000014
ngh & nshi)
(Dr. Rajeev
Drugs Cont ller General(India)
TO,
IT Cell for uploading the information on CDSCO website.
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