Medical device licencing requests issued till September will be valid for 6 months: CDSCO

Written by Dr. Divya Colin Published On 2022-10-05T13:00:42+05:30 | Updated On 5 Oct 2022 1:01 PM IST

New Delhi: With an aim to not disrupt the medical device business continuity due to the implementation of licensing regime, the Government of India, the Director-General of Health Services, the Central Drug Standard Control Organization (CDSCO) has decided that, in case, if an existing importer/manufacturer who is already importing /manufacturing any of Class A or Class B Medical Devices, has submitted application to Central Licensing Authority or State Licensing Authority on or before 30.09.2022, the said application shall be deemed valid.

Furthermore, it is stated that the above mentioned importer/manufacturer can continue to import /manufacture the said device(s) up to 6 months from the date of issue of this order or till the time, the Central Licensing Authority or State Licensing Authority takes a decision on the said application, whichever is earlier.

This came in line with the representations from various Associations and Stakeholders which have been received by this office, requesting that the business continuity should not be disrupted due to the implementation of licensing regime w.e.f. 01.10.2022 for Class A & B medical devices.

The Ministry of Health and Family Welfare (MoHFW) has published a notification, S.O. 648 (E), dated February 11, 2020, specifying all medical devices under sub-clause (iv) of clause (b) of Section 3 of the Drugs and Cosmetics Act, 1940, which is effective April 1, 2020.

It is noted that stakeholders and various associations requested the committee not to discontinue their businesses due to the implementation of the licensing regime w.e.f. October 1, 2022 for Class A and B medical devices.

Earlier Medical Dialogues Team had reported about the entering licensing regime of Class A and Class B non-notified medical devices from October 1st 2022. It also mentioned about CDSCO's online portal to apply for the manufacturing license for Class A and Class B medical devices.

Also Read:Class A, Class B non notified medical devices must enter licencing regime effective on October 10, 2022

According to the New Medical Rules of 2017, there are four categories of medical devices. Class A, Class B, Class C and Class D were the various divisions. Medical devices classified as Class A and Class B are regarded as having minimal and moderate risks, respectively. The State Licensing Authority applies to produce medical devices that fall under these categories. Devices that pose a high or very high risk include Class C and Class D devices. The Central Licensing Authority must receive the application for manufacturing them.

In view of the above, it has been decided that, in case, if an existing importer/manufacturer is already importing /manufacturing any of Class A or Class B Medical Devices, has submitted application to Central Licensing Authority or State Licensing Authority on or before 30.09.2022, as the case may be, for grant of import /manufacturing license in respect of the said device(s) under the provisions of MDR, 2017, the said application shall be deemed valid and the importer/manufacturer can continue to import /manufacture the said device(s) up to 6 months from the date of issue of this order or till the time, the Central Licensing Authority or State Licensing Authority, as the case may be, takes a decision on the said application, whichever is earlier.

To view the official notice, click the link below:

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTA1Nw==

Also Read:CDSCO panel opines Paraxel to study either CKD or heart failure in phase IIb trial of AZD9977,Dapagliflozin FDC

medical deviceclass A medical devicesClass B medical devicescdscoMOHFWlicensing regime

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.