Last Updated on October 9, 2024 by The Health Master
Download DCGI circular dated 12-04-2023 for licensing of Class C & D Medical Devices, the link is given below: In an effort to bring in a smooth transition of the Class C and D non-notified medical devices from the current mandatory registration to licensing regime, the Central Drugs Standard Control Organisation (CDSCO) has directed the manufacturers and importers of these devices to apply for grant of manufacturing or import license with all requisite documents and fees as per the regulation.
According to the CDSCO, the medical devices which are of moderate high risk (Class C) and high risk (Class D) are scheduled to complete transition to licensing regime in 42 months from the date of notification on April 1, 2020. According to this, these medical devices are expected to enter into the licensing regime from October 1, 2023.
The CDSCO has earlier initiated processes for smooth transition, by asking the companies to mandatorily register their products under these Classes with the regulator.
This has been envisaged to help these manufacturers and importers and the regulator to have the data and quality certifications submitted and verified well in advance.
The drug regulator, in a latest circular, pointed out that as per the 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.
The Fifth Schedule of the MDR, 2017 elaborates on the quality management system for medical devices and in vitro diagnostic medical devices, including the general requirements, documentation requirements, management responsibility, resource management, product realisation, design and development, validation of processes for production and service, traceability, monitoring, among others.
“In order to have smooth translation 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,” said Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India).
Must read: Classifications of Medical Devices under the provisions of MDR 2017
He added that the application thus received, will be processed proactively, so that, licensure can be issued within the stipulated timeline in order to avoid any disruption of the supply chain of such medical devices and access to the patients.
According to the MDR, 2017, the manufacturers of the Class C or D devices have to submit the applications through the online portal in stipulated Forms and the CDSCO may use the services of any expert in the relevant field for scrutiny of application and other technical documents, wherever required.
The scrutiny shall be completed within a period of 45 days from the date of online submission of application and in case where the documents are found to be complete and in order, the CLA shall cause an inspection of the manufacturing site carried out under the Rule 23 by a team of officers accompanied by such experts, as may be considered necessary.
The CLA may avail the services of a notified body as per the rules for inspecting the manufacturing site of the Class C and D medical devices.
If the documents furnished are not found to be complete and in order, the CLA shall reject the application and inform the applicant of the reasons for such rejection electronically.
The inspection has to be conducted within a period of 60 days and the inspection report has to be submitted to the CLA, and forward a copy of the same to the applicant.
The CLA, after receipt of the report, if satisfied that the requirements of the rules have been completed shall grant a license or loan license or may reject the application for reasons to be recorded in writing, within a period of 45 days from the date the inspection report has been received, says the MDR, 2017.
Procedure to obtain license for manufacturing of Medical Devices
Procedure for registration of Medical Devices: CDSCO
Registration for sale of Medical Devices: Procedure and conditions
Latest Notifications: Medical Devices
Classifications of Medical Devices under the provisions of MDR 2017
Notified Bodies for Medical Devices
Updated list of Notified Bodies for Medical Devices
Updated list of Medical Device Testing Laboratories (MDTLs)
NPPA asks Pharma Industry to submit price details of 139 formulations
Wet Granulation vs Dry Granulation: Understanding the Key Differences
Ukraine requested for additional medicines, medical equipment: India
AIOCD writes to DCGI on E-Pharmacies
CDSCO revises list of FDCs declared as rational
FDCA cancels 15 product permissions of 6 Pharma Companies: Gujarat
Understanding GMP, cGMP, and WHO-GMP
USFDA gives nod for Azithromycin, used in bacterial infections
Drug alert: 59 out of 1251 samples declared as NSQ in February 2023
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
