**Summary:**
This circular, issued by the Central Drugs Standard Control Organisation (CDSCO) on April 4, 2023, addresses the transition to a licensing regime for Class C and D non-notified medical devices, currently under mandatory registration as per GSR 102E dated February 11, 2020, under the Medical Devices Rules (MDR) 2017. This transition is effective from October 1, 2023.
The circular highlights that, as per MDR 2017, inspections for granting manufacturing licenses for 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 ensure a seamless transition from mandatory registration to licensing, manufacturers and importers are encouraged to apply for manufacturing/import licenses with all required documents and fees as per MDR 2017 via the online portal www.cdscomdonline.gov.in. The CDSCO assures proactive processing of applications to issue licenses within the stipulated timeframe, preventing disruptions to the supply chain and patient access.
The circular is addressed to all stakeholders and associations, with copies sent to all Zonal/Sub-Zonal offices and Port offices of CDSCO. Further inquiries can be directed to Dr. Rajeev, Drugs Controller General.
Key Entities Referenced
Central Drugs Standard Control Organisation: A national regulatory body in India responsible for the regulation of pharmaceuticals and medical devices.
Medical Devices Rules 2017: The regulatory framework in India governing the manufacturing, import, sale, and distribution of medical devices.
Class C and D nonnotified Medical Devices: Categories of medical devices based on risk, that were previously under mandatory registration and are now subject to licensing.
GSR 102E: A gazette notification that specifies the regulatory requirements for 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: Location of FDA Bhawan, where the circular was issued.
Fifth Schedule of MDR 2017: Schedule within the Medical Devices Rules 2017 that outlines the requirements for manufacturing facilities and quality management systems for medical devices.
F. No. 29/Misc/03/2022-DC (94)
Central Drugs Standard Control Organisation
Government of India i
Ministry of Health and Family Welfare
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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.