Stockholm-headquartered Episurf Medical announced that the Indian authorities, the Directorate General of Health Services, Central Drugs Standard Control Organization, Medical Devices Division, confirmed that the company’s Episealer® Knee implant portfolio represents a custom made device that can be imported to India in accordance with the rules for such devices.
This classification follows a review process, and represents an important regulatory milestone for Episurf Medical, as it enables a market expansion in the Indian market. The company has been targeting the Indian market for several years, but a final decision on the regulatory classification was needed before commercial activities via its subsidiary Episurf India Ltd could be initiated at a larger scale.
Pål Ryfors, CEO, Episurf Medical said, “All the work performed by us in India, while waiting for this regulatory decision, has confirmed that there is a large clinical need for patients who are between biological procedures. We will now go ahead with our plans to introduce the Episealer® Knee implant portfolio in India. The fast growing Indian healthcare market represents a significant commercial opportunity for us, and we can finally take the next steps.”
