Issues faced by manufacturers, especially smaller companies, included delays and complexities in the licensing process
Medical device makers can now outsource sterilisation through third-party agreements without loan licences if the facility holds a valid sterilisation licence
The Central Drugs Standard Control Organisation (CDSCO) has relaxed the requirement of a loan licence for outsourcing the sterilisation of medical devices to other facilities. Manufacturers are now allowed to carry out such activities by way of a mutual third-party agreement, provided those facilities hold a valid licence to undertake the process.
Sterilisation of medical devices is the process of eliminating or reducing microbial contamination to a level that ensures they are safe for use in healthcare settings.
Previously, manufacturers without in-house sterilisation facilities were required to utilise the premises of other manufacturers through a loan licence.
Such a licence is issued by the central or state licensing authority to a person who intends to utilise another licensee’s manufacturing site for sterilising the same medical device as manufactured by the licensee at that site.
