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

Furthermore through the notice, the Government of India, the Director-General of Health Services, Central Drug Standard Control Organization (CDSCO) has elucidated the manufacturers about the prescribed regulatory pathway for obtaining the licensure for all the non-notified medical devices of Class A and Class B categories.

According to the New Medical Rules,2017 there are four categories for medical devices. Class A, Class B, Class C, and Class D are 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 submits an application 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.

A transition period of 30 months had been provided for Class A & Class B medical devices from date of implementation of G.S.R. 102(E) i.e., 01.04.2020 for the transition to licensing regime. During that period the manufacturers were required to register their products on the on the portal (https://cdscomdonline.gov.in/NewMedDev/Homepage) established for the purpose of CDSCO and to affix the registration number on the label of such registered medical devices.

However, as per the recently published notification, the authorities noticed that some other entities are issuing quality certificates to the manufacturers at their level, which had become confusing for manufacturers about the prescribed regulatory pathway for obtaining the licensure for all the medical devices under Medical Device Rules (MDR),2017 by the competent Licensing Authority.

In this regards, the notice stated, "it is hereby clarified that such quality certificates issued by other entities shall not be a replacement of licensure to be granted under MDR, 2017 by the competent Licensing Authority."

"All manufacturers shall have to comply with the licensing requirement and obtain the license aa per MDR, 2017, as the said rules do not recognize any such certificates which are not mentioned in it or part of it.", the notice further added.

In addition to this, advising on the process of obtaining manufacturing license, the Director-General of Health Services, Central Drug Standard Control Organization (CDSCO) clearly stated, "It is again advised that all manufacturers shall apply for obtaining manufacturing license for Class A & Class B medical devices through CDSCO's on-line portal so that the manufacturing license can be granted by respective State Licensing Authorities after review of the applications and audit (as the case may be) as per stipulated time specified in MDR, 2017 in order to avoid further delay."

In this regard this office has proactively taken up the issue vide notice No. 29/Misc/03/2022- DC (94) dated 25.04.2022, requesting all State Licensing Authorities (SLAs) to dispose of the applications received by them as per MDR, 2017 in time to avoid the disruption of the supply of such devices to the paients.