In relief to importers & manufacturers of medical devices, the apex regulator CDSCO, i.e. Central Drug Standard Control Organisation, has extended the date to furnish the application form for license to June 30, 2022.The decision was taken as the manufacturers & importers of medical devices and equipment have failed to comply with the requirement of securing a license from the said authority within the stipulated timeframe. The license for medical device can be secured after filing a prescribed application on the official portal.
What types of medical devices are covered in the recent Notification?
To ensure uninterrupted access to medical-based devices notified as drugs while the new regulatory order under MDR, i.e. Medical Device Rules, is enforced, CDSCO has decided that a manufacturer/producer who is already engaged with the manufacturing /importation of medical devices, including MRI equipment, CT scan equipment & whose application already been furnished the apex regulator or State License Authority for grant of the license would be considered valid.
Furthermore, it also confirmed that the manufacturer/importer can continue to perform their business activities up to 30.06.2022 or till the duration the said authorities takes a decision on the said application, whichever is earlier.
The Central Government, in association with the Drugs Technical Advisory Board, had specified the below-mentioned devices for the use in patients as drugs with effect from 1/4/2020, viz;
- All implantable medical devices;
- CT scan Equipment;
- MRI Equipment;
- Dialysis Machine;
- X-Ray Machine;
- PET Equipment;
- Bone marrow cell separator
Medical Device Rules Mandates Manufacturer/Importer to Secure License for Medical devices
As per the new notification norms cited in Medical Device Rule (MDR), 2017, the manufacturers as well as importers are mandated to secure an import or manufacturing license from the apex regulator or a State Licensing Authority of the specified eight medical devices with effect from April.
But, in this context, the stakeholders expressed their concern that due to the Cornovirus disruption, there is unpreparedness in fulfilling the regulatory requirements within the given timelines, which may disrupt the supply chain.
Casting light on the Notification Rolled out by CDSCO.
In view of the above, the apex regulator i.e. CDSCO, has rolled out a notification, stating;
“Now, therefore, in order to ensure a seamless transition of importers/manufactures, continuity of supply chain as well as the access to the patients, with the consent of MoHFW, it has been decided that in case a prevailing manufacturer/importers who is already engaged with the manufacturing/importation of any those devices, & whose application form has been furnished to the concerned authorities for the grant of the license relating to the said device(s) under norms of MDR, 2017 by 18.04.2021, the said application shall stand valid and the importer/manufacturer, can continue to perform their business undertaking relating to said devices up to 30.06.2022 or till the time the concerned authority finalize the decision on the said application, whichever is earlier.
Moreover, the notice confirmed that the applicant who has furnished an incomplete application (furnished by or before April 18, 2021) must furnish all the required documents to the authority by 31.03.2022. The notice further clarified that the Central Licensing Authority or State Licensing Authority should reject this application within three months from the receipt date of the complete application
Moreover, the importer/ manufacturer of the medical devices has to secure a relevant license for the aforementioned said devices by or before July 30, 2022. The importer/manufacturer must print the license number on the label w.e.f 01/07/2022
Functions Performed by CDSCO in India
The Central Drugs Standard Control Organisation (aka CDSCO) under the aegis of the Ministry of Health & Family Welfare, Directorate General of Health Services, GOI is the national regulatory authority (aka NRA) of India. The authority is also responsible for disbursing License for Medical device.
It is headquartered at FDA Bhawan, Kotla Road, New Delhi & also possesses 6 zonal offices, four sub-zonal offices, 13 port offices & 7 labs spread established pan India.
The authority operates under the ambit of the Drugs & Cosmetics Act, 1940 and rules 1945. It aims to ensure seamless implementation of the provisions cited in the said Act to ensure the well-being and safety of the patient by regulating the drugs & cosmetics.
Further, the apex regulator is continually striving to improve accountability, transparency, & uniformity of its services to ensure better safety and quality of the medical product produced, shipped, & distributed in the country.
As per the governing Act, CDSCO is liable for;
- Approving Clinical Trials of drugs
- Underpinning standards for Drugs
- Curbing the movement of overseas drugs and establishing relevant measures for the same
- Prompting State Drug Control Organizations by rendering expert advice for effective enforcement of the Drugs and Cosmetics Act
Moreover, CDSCO, in association with the state regulators, is liable for grant of licenses of certain categories of drugs such as I. V. Fluids, blood and blood products, Vaccine and Sera.
The said Notification released by CDSCO aims to extend the application submission date of license for aforesaid medical devices till next year, i.e. June 30, 2022. This came as a great relief for the manufacturers and importers of the devices operating in India. Applicants who have already submitted the license application by April 18, 2021, shall continue to undertake their business undertakings up to June 30, 2022. The authority shall disburse License for Medical device after scrutinizing the application & submitted credentials.
Read our article:CDSCO: Extension of Medical Device Compliance Deadlines to 2021