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Parliamentary Panel asks Centre to take genuine efforts to implement recommendations of Forum

Gireesh Babu, New Delhi
Monday, February 3, 2025, 08:00 Hrs  [IST]

The Parliamentary Standing Committee on Ministry of Chemicals and Fertilisers has sought the Centre to take genuine efforts to implement the recommendations of the Standing Forum on Medical Device Association related to streamlining logistics and optimising transition towards licensing of all types of medical devices, among others.

The Panel, in its report analysing the action taken by the government on the observations and recommendations of the committee in their previous report (15th report of the 17th Lok Sabha) on Promotion of Medical Device Industry, released in December, 2024, said that the action taken note submitted by the Ministry on its previous recommendations regarding the topic was not only ambiguous, but also devoid of facts.

The Standing Forum of Medical Devices Associations, formed by the Department of Pharmaceuticals (DoP) in August, 2021, has recommended various measures in terms of mapping of testing infrastructure for medical devices in a report to the ministry of health and family welfare.

The Panel, in its earlier report opined that the with the transition towards licensing of all types of medical devices, the requirement of testing equipment and testing infrastructure for Class A, B, C and D type of medical devices will increase and in this regard the recommendations given by the Standing Forum on Medical Device Associations will be of immense value. In this regard, the Panel suggested the DoP to ensure that the ministry of health and family welfare soon consider the report of the Forum and take suitable and timely action on its recommendations.

The health ministry informed that in order to increase the medical devices testing facility in the country, all stakeholders were requested in April, 2024 to identify and register their facility for testing medical devices on behalf of the manufacturer.

In March itself, the existing laboratories were also requested to submit the endorsement application for expanding scope of testing facility for other categories of medical devices which are not included in the existing registration certificate.

Besides, the Ministry incorporated a provision in the Medical Device Rules, 2017, through a notification in June, 2023, to enable State governments to notify their laboratories with relevant facilities, as State Medical Devices Testing Laboratory and also to notify Medical Devices Testing Officers. The drug regulator has also asked the Central Medical Devices Testing Laboratories to identify and expand scope of medical devices testing, it added.

Taking note of the action taken report, the Panel in its latest report said, "The Committee feels that the Action Taken Note submitted by the Ministry is not only ambiguous but is also devoid of facts.  The soft peddling being done by the Ministry to ask the existing medical device testing laboratories to submit without any follow up action clearly indicates the casual approach of the Ministry in dealing with the critical issue of such magnitude."

The Panel said that it is of the view that the Ministry should make genuine efforts to take cognizance of the recommendation given by the Standing Forum on Medical Device Association in order to streamline logistics and also to optimize the transition towards licensing of all types of medical devices and requirement of testing equipment and testing infrastructure for Class A,B,C and D type of medical devices.

"The Committee further desires that the Ministry of H&FW/CDSCO ought to monitor implementation of the recommendations of the standing forum and device a framework to establish right kind of environment and infrastructure to ensure smooth transition. The Committee may be apprised of the progress/status from time to time," it added.

The ministry of health, through a notification issued on February 11, 2020, brought all non-notified medical devices under regulation and categorised the medical devices into four classes based on the risk related to the devices. Based on the decisions, the Class A and B medical devices have come under licensing regime with effect from October 1, 2022 and Class C and D medical devices have come under licensing regime with effect from October 1, 2023.

 

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