Indian authorities have, through their Directorate General of Health Services, Central Drugs Standard Control Organisation, Medical Devices Division, confirmed that Episurf Medical’s Episealer® Knee implant portfolio represents a custom made device that can be imported to India in accordance with the rules for custom made 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. Episurf Medical 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 could be initiated at a larger scale.
“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 and knee replacement prostheses. Surgeons are clearly struggling with this patient group, and we will now go ahead with our plans to introduce the Episealer Knee implant portfolio in India,” said Pål Ryfors, CEO, Episurf Medical.
Indian authorities have, through their Directorate General of Health Services, Central Drugs Standard Control Organisation, Medical Devices Division, confirmed that Episurf Medical's Episealer® Knee implant portfolio represents a custom made device that can be imported to India in accordance with the rules for custom made devices.
This...
Indian authorities have, through their Directorate General of Health Services, Central Drugs Standard Control Organisation, Medical Devices Division, confirmed that Episurf Medical’s Episealer® Knee implant portfolio represents a custom made device that can be imported to India in accordance with the rules for custom made 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. Episurf Medical 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 could be initiated at a larger scale.
“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 and knee replacement prostheses. Surgeons are clearly struggling with this patient group, and we will now go ahead with our plans to introduce the Episealer Knee implant portfolio in India,” said Pål Ryfors, CEO, Episurf Medical.
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