NASSCOM Submits Comments to Ministry of Health and Family Welfare on the draft Medical Devices Rules, 2022

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NASSCOM Submits Comments to Ministry of Health and Family Welfare on the draft Medical Devices Rules, 2022

Devika Agarwal

@DevikaAgarwal

September 30, 2022

Public Policy

307

On September 20, 2022, the Ministry of Health and Family Welfare (MoHFW) released the draft Medical Devices (Amendment) Rules, 2022 (draft Rules) for public consultation until September 27, 2022. The draft Rules seek to simplify the extant registration process for Class A (non-sterile and/or non-measuring) medical devices (“Class A NSNM devices”) by allowing self-certification and self-attestation by manufacturers/importers of such devices. NASSCOM submitted its feedback to MoHFW on the draft Rules on September 27, 2022.

The main recommendations made by NASSCOM are as follows:

Need for clarity on the applicability of the various Chapters of the Medical Devices Rules, 2017 (MDR 2017):

The draft Rules clarify that chapters IV (‘Manufacture of medical devices for sale or for distribution') and V (‘Import of medical devices’) of the MDR 2017 will not apply to Class A NSNM devices. However, the draft Rules do not clarify how Chapters VI (‘Labelling of medical devices’), VII (‘Clinical investigation of medical devices and clinical performance evaluation of new in vitro diagnostic medical device’), VIII (‘Import or manufacture medical device which does not have its predicate device’) and IX (‘Duties of Medical Device Officer, Medical Device Testing Officer and Notified Body’) will apply.

Need for clarity on the treatment of the license fee already paid by manufacturers and importers as per Chapter IIIA, MDR 2017:

In February 2020, the MoHFW introduced Chapter IIIA to the MDR 2017 which required all manufacturers and importers of Class A medical devices (including NSNM devices) to register their devices by October 1, 2022, by paying specific license fees. Since the draft Rules propose a registration process which dispenses with licensing fees, there is a need to clarify how the license fees already paid will be treated going forward.

Need for guidance on the classification of Class A NSNM devices:

At present, the draft Rules do not provide any guidance on what amounts to non- sterile and non-measuring devices under Class A of the First Schedule of the MDR 2017. As per industry feedback, the lack of such guidance could lead to erroneous classification which may risk safety.

Need for exemption from stock and sale license for Class A NSNM devices:

The draft Rules need to clarify whether there is an exemption from the requirement to obtain a stock and sale license for Class A NSNM devices which are low-risk, primarily sold through mass channels and do not require any special storage or handling. An exemption will reduce unnecessary compliance burden on the sellers of such devices and ensure maximum reach of such devices.

[The full text of NASSCOM’s recommendations is appended. For any queries related to this submission, please reach out to dagarwal@nasscom.in and sudipto@nasscom.in with a copy to policy@nasscom.in]

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