In an update to the Medical Device Rules 2017, the Drugs Controller General of India has appointed two global product testing, certification and inspection companies to audit the manufacture of Class A and Class B medical devices in compliance with 'Quality Management System' guidelines issued by the Central Drugs Standard Control Organization.
The two companies with operations in India that have been appointed as 'notified bodies' are:
- 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.: +91-11- 41595475, +91-9310412823 Fax: +91-11-41595460; E-Mail: firstname.lastname@example.org
- 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.: +91-80-46498030 Fax: +91-80-46498042; E-Mail: email@example.com