NABCB Approved Certification bodies
We are getting lot of enquiries form Domestic Manufacturers of Medical Devices about ICMED Certifications Schemes and also about the the notified bodies that can issue these Certifications in India.
Indian Certification for Medical Devices (ICMED) Scheme is a Voluntary Certification Scheme launched by Quality Council of India to encourage Indian Medical Device Manufacturers to opt for these Medical Devices Quality Management Systems Certifications Scheme.
Details about this Scheme are available in QCI’s Website –
https://www.qcin.org/icmed-medical.php
Most of the PPE Manufacturers & Textile Manufacturers who are undergoing Training on ICMED 9000, ICMED 13485 have been asking for the details of Certification Bodies which are approved by QCI NABCB
(http://nabcb.qci.org.in/index.php)
to issue ICMED Certifications. Following is the list of CBs approved for ICMED Schemes.
| Certification No. : | ICMED/001 |
| Certification Body : | M/s Intertek India Pvt. Ltd. |
| Certificate Validity: | ISO/IEC 17021 Accreditation Certificate valid till 17 April 2022 |
| Contact Person : | Dr. Srisathya B |
| Designation: | Manager – Accreditation |
| Address : | F Wing, 2nd Floor Tex Centre,Chandivali Farm Road, Andheri (East), Mumbai-400072 |
| Tel : | 22 6719 7940 |
| Fax : | 22 6703 8688 |
| Email: | srisathya.balasubramanian@intertek.com |
| Scope: | ICMED 9000 ICMED 13485 |
| Certification No. : | ICMED/004 |
| Certification Body : | M/s TÜV InterCert Saar India Pvt Ltd |
| Certificate Validity: | ISO/IEC 17021 Accreditation Certificate valid till 26 Oct 2020 |
| Contact Person : | Mrs. Aradhana Mishra |
| Designation: | GM – Food Safety and Certification In-charge |
| Address : | No. 122/1, 3 rd Main Road, Margosa Road, Malleswaram, Bangalore – 560 003 |
| Tel : | 080 – 41285610 / 9972375490 |
| Fax : | N.A. |
| Email: | amishra@tuvintercert.in |
| Scope: | ICMED 9000 schemeICMED 13485 scheme(All scopes as per IAF MD9, except 1.3) |
| Certification No. : | ICMED/005 |
| Certification Body : | M/s TUV SUD South Asia Pvt. Ltd. |
| Certificate Validity: | ISO/IEC 17021 Accreditation Certificate valid till 28th April, 2020 |
| Contact Person : | Mr. Rahul Kale |
| Designation: | Head of Certification body |
| Address : | TUV SUD Office, Off Saki Vihar, Saki Naka, Andheri East, Mumbai – 400072 |
| Tel : | 022 – 49035555 |
| Fax : | N.A. |
| Email: | Rahul.kale@tuv-sud.in |
| Scope: | ICMED 9000 scheme ICMED 13485 scheme |
| Certification No. : | ICMED/ 006 |
| Certification Body : | M/s TUV Rheinland (India) Pvt. Ltd. |
| Certificate Validity: | ISO/IEC 17021 Accreditation Certificate valid till 15 August 2023 |
| Contact Person : | Mr. Guruprasad B.Ra |
| Designation: | Quality Management Representative |
| Address : | No. 82/A, West Wing, 3 rd Main Road, Electronic City Phase – 1, Bangalore – 560100 |
| Tel : | 9620288803 |
| Fax : | N.A. |
| Email: | guruprasad.br@ind.tuv.com |
| Scope: | ICMED 9000ICMED 13485 1.1 Non-active Medical Devices 1.2 Active Medical Devices (Non Implantable) 1.5 Sterilization Method for Medical Devices |
| Certification No. : | ICMED/007 |
| Certification Body : | M/s International Certification Services Pvt. Ltd. |
| Certificate Validity: | ISO/IEC 17021 Accreditation Certificate valid till 14 Dec 2023 |
| Contact Person : | Mr. Sumeet Kataria |
| Designation: | Country Manager |
| Address : | 22/23 Goodwill Premises, Swastik Est, Kalina, Santacrux East, Mumbai 400098 |
| Tel : | 022 – 42200904 |
| Fax : | N.A. |
| Email: | Sumeet.kataria@icsasian.com |
| Scope: | ICMED 9000 ICMED 13485(Scopes 1.1, 1.2 & 1.5 as per IAF MD8) |
| Certification No. : | ICMED/008 |
| Certification Body : | BSI Group India Pvt. Ltd. |
| Certificate Validity: | ISO/IEC 17021 Accreditation Certificate valid till 19 February 2023. |
| Contact Person : | Mr. Sandeep Dua |
| Designation: | Head Compliance & Risk – India |
| Address : | The Mira Corporate Suites (A-2), Plot 1 & 2, Ishwar Nagar, Mathura Road, New Delhi – 110 06 |
| Tel : | 011 2692 9000 (eight lines) |
| Fax : | 11 2692 9001 |
| Email: | sandeep.dua@bsigroup.com |
| Scope: | ICMED 9000 ICMED 13485 |
Download Presentation on ICMED Scheme :
https://www.qcin.org/Presentation%20on%20CB%20approval%20process-%20ICMED.pdf
Also please check the list of CBs approved by NABCB to issued ISO 13485 Certifications under MDQMS Scheme
Its recommended that manufacturers while opting for both ISO 13485 and ICMED Certifications, choose a Certification Body which can issue both simultaneously after conducting a single audit.
NABCB secures International Equivalence for Medical Devices – Quality Management Systems (MDQMS) . Click the link to read more