The Central Drugs Standard Control Organization (“CDSCO”) has released a list of registered Notified Auditing Bodies on August 6th, 2018 who can audit manufacturing sites under Rule 12 of Medical Device Rules, 2017 (“Rules”).
Background:
As per Rule 12 of the Rules, an accredited Notified Body will be competent to carry out audit of manufacturing sites of Class A and Class B medical devices, to check whether they conform with the Quality Management System and other applicable standards as advised by the State Licensing Authority.
The Drugs Controller General of India under the Rules, states that only the Notified bodies can Audit companies that are into manufacturing of medical devices, thus no other individual/ institution/ organization/party apart from the notified bodies are allowed to audit the manufacturing sites of Medical Device manufacturers.
In furtherance to the above, CDSCO has in a recent notice dated 6th August,2018 listed the registered bodies who can carry out the audit:
- M/s. Intertek India Pvt. Ltd
- M/s TUV Rheinland India Pvt. Ltd
- M/s TUV Sud South Asia Pvt. Ltd
- M/s. Dnv GI Business Assurance India Private Limited
Source: Central Drugs Standard Control Organization
