Medical device makers likely to get time extension for licences, says report

New Delhi: In the wake of delays in issuing new regulatory licences, the government may grant an extension to manufacturers of high-risk medical equipment, such as ventilators, nebulisers, and x-ray machines, to continue production for a "limited duration", a senior official has informed Economic Times.

As per the latest media report, the Central Drugs Standard Organisation (CDSCO) missed its October 1st deadline to distribute licences to these manufacturers. As a result, an extension might be granted to those producers who have already submitted their applications. However, manufacturers who have not applied will not benefit from this grace period, the official noted.

The October 1st cut-off marked the date for the mandatory inclusion of 'class C' and 'class D' medical devices, representing 'moderate' and 'high' risk categories, under the CDSCO's regulatory umbrella. This integration was initiated by the government's resolution to mandate certification by the drug regulator for all imported and locally-produced medical devices sold in the country before their market introduction, ensuring quality standards are met.

As per earlier reports, numerous manufacturers communicated that they had applied for the necessary licences back in July. Yet, they are still in anticipation of the critical audits, which will determine their licensing eligibility.

Medical equipment risk categorization is determined based on the potential hazards they present to users.

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