High-Risk Medical Device Makers May Get License Extension

Manufacturers of high-risk medical devices, including ventilators, nebulizers, and x-ray equipment, may receive an extension to continue production due to a delay in the issuance of new regulatory licenses, according to a senior government official.

The Central Drugs Standard Organisation (CDSCO) missed the October 1 deadline for issuing licenses, leading to the possibility of extensions for manufacturers who have already applied for licenses but have not received them yet. Those who have not yet applied for licenses will not be granted extensions.

The October 1 deadline was set to bring ‘class C’ and ‘class D’ medical devices, which are considered ‘moderate’ and ‘high’ risk, under CDSCO regulation. This move was part of the government’s initiative to require certification by the drug regulator for all imported and locally manufactured medical devices before they can be sold in the country, ensuring quality standards are met.

Manufacturers have reported that they applied for licenses in July but are still awaiting audits, which will determine whether they receive licenses. Medical devices are categorized based on the level of risk they present.