Pancreatic cancer treatment device company OncoSil Medical Limited (ASX:OSL) has successfully received UK Conformity Assessed (UKCA) renewal certificates from the British Standards Institution (BSI) for the OncoSil device, with no post-market restrictions.
This certification highlights the solid clinical evidence supporting the safety of the OncoSil device and enables continued access to the UK market without additional compliance burdens.
The removal of all post-market restrictions will allow OncoSil to operate more efficiently in the UK, streamlining regulatory requirements, reducing associated costs and accelerating the sales cycle. The UKCA certification, issued by BSI, is an important regulatory milestone that reaffirms the company’s commitment to maintaining high standards of safety and effectiveness in pancreatic cancer treatment.
In parallel, OncoSil is expecting to receive Medical Device Regulation (MDR) approval from BSI in the near future, which will further strengthen its market position across Europe and expand patient access to this innovative treatment.
“Receiving the UKCA renewal certificates without any post-market restrictions from BSI is a major accomplishment for OncoSil Medical,” CEO and Managing Director, Nigel Lange, said.
“This achievement not only reinforces the trust in the safety of our device but also simplifies our operations in the UK. We are also anticipating MDR approval from BSI shortly, which will unlock even greater opportunities across the European market.
