Parliamentary Panel Urges Expanded Audit of Medical Device Units

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The Parliamentary Panel, which looked into promoting the medical device industry in the country, expressed dissatisfaction with the lack of adequate notified bodies available to undertake audit duties and inspections of medical devices. 

At manufacturing sites, necessary arrangements should be made to complete the license issuance process to the manufacturers of all kinds of medical devices in a time-bound manner.

The Department-related Parliamentary Standing Committee on Chemicals and Fertilisers, in its 50th report on the Promotion of the Medical Devices Industry, was informed by the Department of Pharmaceuticals that under Medical Device Rules, 2017, 13 Notified Bodies have been registered to audit and inspect manufacturing sites of Class AandB medical devices for quality standards. For Class CandD medical devices, audits are conducted by Central Medical Device Officers.

The Committee, however, said that it is not satisfied to note that there are only 13 Notified Bodies to undertake audit duties and inspections of medical devices at manufacturing sites.

"The Committee, therefore, desires that immediate measures be taken to increase the number of Notified Bodies and equip them with suitable technical infrastructure and manpower to carry out audit functions for handling the humongous task of ensuring quality, safety and efficacy of Class A and medical devices manufactured in our country," said the panel headed by Lok Sabha member Dr Shashi Tharoor.

"Further, the Committee trusts that the Department of Health and Family Welfare will take the utmost care to ensure that the Central Medical Device Officers are well equipped and trained to conduct audits of Class C and D medical devices in the country.