**Summary:**
This circular, issued by the Central Drugs Standard Control Organisation (CDSCO) on April 4, 2023, addresses the transition of Class C and D non-notified medical devices from mandatory registration to a licensing regime, effective October 1, 2023, as per GSR 102E dated February 11, 2020, under the Medical Devices Rules (MDR) 2017. The circular emphasizes that, according to MDR 2017, inspections for manufacturing licenses of Class C and D medical devices must be conducted within 60 days of application by Medical Devices Officers (MDO) of the Central Licensing Authority (CLA) to ensure compliance with the Fifth Schedule of MDR 2017. To facilitate a smooth transition and prevent supply chain disruptions, manufacturers and importers are encouraged to proactively apply for manufacturing/import licenses with all necessary documents and fees via the www.cdscomdonline.gov.in portal. The CDSCO assures that applications will be processed promptly to issue licenses within the stipulated timeframe. The circular is addressed to all stakeholders and associations and copied to all Zonal/Sub-Zonal offices and port offices of the CDSCO. The contact person for further information is Dr. Rajeev, Drugs Controller General.
Key Entities Referenced
Central Drugs Standard Control Organisation: A regulatory body in India responsible for the regulation of pharmaceuticals and medical devices.
Ministry of Health and Family Welfare: A government ministry in India responsible for public health.
Medical Devices Rules 2017: The regulatory framework in India governing medical devices.
Class C and D nonnotified Medical Devices: A risk classification of medical devices under the Medical Devices Rules 2017.
GSR 102E dated 11.02.2020: A gazette notification related to the regulation of medical devices in India.
Central Licensing Authority: The authority responsible for issuing manufacturing licenses for Class C and D medical devices.
Dr Rajeev: Drugs Controller General of India
New Delhi: City in India, location of FDA Bhawan and Central Drugs Standard Control Organisation.
F. No. 29/Misc/03/2022-DC (94)
Central Drugs Standard Control Organisation
Government of India i
Ministry of Health and Family Welfare
ok ok ok kK a ae
FDA Bhawan, New Delhi
Dated the April, 2023
CIRCULAR 4 2 APR 2023
Subject: Licensing regime of Class C & D non-notified medical devices which are
currently under mandatory registration, as per GSR 102(E) dated 11.02.2020, under
Medical Devices Rules 2017, w.e.f from 01.10.2023 - Regarding.
As you are aware, that the Class C and D non-notified Medical Devices which are currently
under mandatory registration, will be under licensing regime w.e.f 01.10.2023, as per GSR 102(E)
dated 11.02.2020.
It is pertinent to mention that, as per Medical Devices Rules (MDR) 2017, for grant of
manufacturing license of Class C and D medical devices, the inspection needs to be carried out
within 60 days from the date of application by the Medical Devices Officers (MDO) of Central
Licensing Authority (CLA), to ensure the compliance with Fifth Schedule of MDR 2017.
In order to have smooth transition from mandatory registration to licensing regime, it is suggested
that, the manufacturers/importers may apply for grant of manufacturing/import license with all
requisite documents and fees as per MDR 2017, through www.cdscomdonline.gov.in portal. The
application received will be processed proactively, so that, licensure can be issued within the
stipulated time line in order to avoid any disruption of the supply chain of such medical devices and
access to the patients.
(Dr Rajeev
Drugs Controller General (I)
To
All Stakeholders/Associations.
Copy to:
1. All Zonal/Sub-Zonal offices of CDSCO
2. All Port offices.