Scandinavian Chemotech proudly announces the upgrade of its subsidiary's Central Drugs Standard Control Organization (CDSCO) approval for IQwave™ from voluntary registration to a full license under the Medical Devices Rules (MDR) 2017. This approval grants ChemoTech's subsidiary to market and sell IQwave systems in India.
The newly granted MD-15 license authorizes the import and commercial distribution of IQwave™, a CE-marked electroporation system from Scandinavian ChemoTech designed for tumor-specific electrochemotherapy using multi-directional electrical fields to enhance chemotherapy uptake in solid superficial tumors.
"This regulatory advancement marks a pivotal step to continue making advanced, non-invasive cancer treatments accessible to Indian patients," said Mohan Frick, CEO, Scandinavian Chemotech AB. "With the MD-15 license, we can now scale IQwave™ deployment nationwide, supporting clinicians in delivering precise, efficient therapies under local anesthesia."
Obtaining the import licence does not change the company's previously established strategy in short term. The company will continue to primarily focus on and prioritize Animal Care, in line with the agreed plan. However, the import licence ensures that the company now has the necessary regulatory foundation to commercialize it's products in India when deemed appropriate.
This disclosure contains information that ChemoTech is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 17-03-2026 13:37 CET.