The Drugs Controller General of India (DCGI) has started the process of registration of notified bodies to carry out audit of manufacturing sites of Class A & Class B medical devices as laid down in the Medical Device Rules 2017 which will come into effect in the country from January 1, 2018.
The Medical Device Rules 2017 have already been published vide G.S.R. 78 (E) dated 31.01.2017 under Drugs and Cosmetic Act, 1940 to regulate the clinical investigation, manufacture, import, sale and distribution of the medical devices. The Chapter III (Rule 13) of Medical Device Rule 2017 provides for the registration of notified bodies with the DCGI office (CDSCO).
Subsequently, with effect from July 1, 2017, the notified bodies have to file their application to the Central Licensing Authority (DCGI) for registration in Form MD-1 through online portal to carry out the audit of manufacturing sites of Class A & Class B medical devices to verify conformity with the Quality Management System and other applicable standards. In this regard, CDSCO has put in place an online portal for the registration of notified bodies.
For this purpose, the DCGI has convened a meeting of all notified bodies on April 17 at FDA Bhawan, New Delhi to demonstrate the alpha version and validation of online submission of application for their registration.
As per Chapter III (Rule 13) of Medical Device Rule 2017, any institute, organisation or body corporate may seek accreditation, after notification of these rules, as a Notified Body by applying to the National Accreditation Body referred to in rule 11 in such form and manner as may be determined by the National Accreditation Body from time to time. The Notified Body accredited under sub-rule (1) shall be competent to carry out audit of manufacturing sites of Class A and Class B medical devices to verify conformance with the Quality Management System and other applicable standards as specified under these rules in respect of such medical devices as and when so advised by the State Licensing Authority.
Any Notified Body accredited under sub-rule (1) shall, if it intends to carry out audit of a manufacturing site of Class A or Class B of medical devices in accordance with sub-rule (2), register with the Central Licensing Authority. Any Notified Body under sub-rule (3), with an experience of at least two years, may apply to the Central Licensing Authority for registration as a Notified Body for carrying out audit of Class C and Class D medical devices, provided it has personnel with requisite qualification and experience.
With effect from the 1st day of the July, 2017, the Notified Body accredited in accordance with sub-rule (3) may make an application to the Central Licensing Authority for registration in Form MD-1 through online portal accompanied with a fee specified in the Second Schedule along with documents as specified in Part I of the Third Schedule. The Central Licensing Authority, on being satisfied, shall register the Notified Body and issue a registration certificate in Form MD-2.