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20.3 In addition, reference was also made to the fact that MHFW had issued a notification to specify devices intended for use in humans and animals as drugs, effective 01.04.2020 only after having consulted DTAB. 20.4 The response went on to state that to regulate non-notified medical devices, MHFW had issued the 2nd 2020 Notification to amend the 2017 Rules. It was conveyed that all non-notified medical devices, effective 01.04.2020, would have to be registered with the Central Licensing Authority [hereafter referred to as "CLA"] via an online portal established by CDSCO. The response stated that upon successful registration with CDSCO, the system would generate a number, which the applicant would have to affix to the medical device. It was made clear that for 18 months, there would be leeway provided to the manufacturer/exporter, i.e., the applicant, regarding the registration, which would morph into a mandatory requirement after the said timeframe expires.

21. At this juncture, it may be relevant to note that, in the interregnum [i.e., before the receipt of the communication dated 03.06.2020], the Association, after coming across reports in the media concerning the introduction of a Bill concerning medical devices, had filed on 08.11.2019 and 19.11.2019, applications under the RTI Act with Niti Aayog and CDSCO (HQ) DGHS. Although the Association received a response dated 23.12.2019 from CDSCO via the Deputy Drugs Controller, no response was received from Niti Aayog.

two (42) months for those devices that fell in class C and D. Thus, the licensing regime for Class A and B devices under the 1st 2020 Notification became effective from 01.10.2022. In contrast, for class C and D devices, it will become effective from 01.10.2023.

(v). Towards this end, twenty-six (26) categories of medical devices, such as neurological, oncology, gastroenterology, nephrology and renal care, have been classified in consultation with stakeholders to enable easy filing of applications. These lists are uploaded from time to time on CDSCO's website, i.e., https://cdsco.gov.in

(viii) The respondent has also prepared the following guidance document for medical devices and In-Vitro Diagnostics:

"(i). Guidance documents & Frequently Asked Questions (FAQ) on medical devices and in vitro diagnostics is uploaded on CDSCO website.
(ii). Guidance document on Grouping of Medical Devices and IVDs.
(iii) Essential Principle for Safety of Performance of Medical Devices uploaded in the CDSCO website.