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Overcoming Regulatory Challenges, CS MEDICA Expands its Footprint in Asia with Latest Approvals
CS MEDICA A/S, a Danish MedTech specializing in pain management, autoimmune diseases, and stress-related disorders, is pleased to announce a milestone in its Asian market expansion strategy.
The Pain Patch has been officially approved as a general medical device (GMD) in Malaysia, marking it the second product authorized for sale in the country. In addition, CS MEDICA has successfully achieved trademark registration for CANNASEN® in Thailand, further solidifying its brand presence in the Asian market.
About the CANNASEN® Pain Patch
The CANNASEN® Pain Patch is an innovative treatment for managing joint and muscle pain. Applied externally to the affected area, the Pain Patch provides a cooling sensation and long-lasting pain relief. Ideal for alleviating muscle, neck, back, and shoulder pain, as well as treating sprains, sports injuries, and arthritis.
Classified as a Class I medical device under Europe's Medical Device Regulation (MDR) 2017/745, the CANNASEN® Pain Patch is also approved for sale by the US FDA, AUS TGA, UK MHRA, Israel, and now, Malaysia. This approval underscores the product's safety and effectiveness, reinforcing CS MEDICA's commitment to providing high-quality treatments.
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Overcoming Regional Regulatory Challenges
Malaysia serves as a strategic entry point for CS MEDICA due to its progressive regulatory environment, and the approval of the CANNASEN® Pain Patch in Malaysia marks a significant achievement, particularly given the stringent regulatory challenges associated with products containing CBD in Asia. While CBD, a non-psychoactive compound derived from cannabis, faces varying degrees of regulatory scrutiny in different countries, CS MEDICA has demonstrated compliance by proving no THC traceability, meeting standards of ppb (parts per billion).
CEO Lone Henriksen comments, "The approval of the CANNASEN® Pain Patch is another essential step in our Asian expansion strategy. It supports our goal to introduce innovative healthcare solutions across the region, starting with Malaysia. "
Trademark Approval in Thailand
In addition to the product approval in Malaysia, CS MEDICA has achieved trademark registration for its CANNASEN® brand in Thailand. This strategic milestone will strengthen brand recognition and market positioning in Thailand and other Southeast Asian countries, paving the way for future product launches.
Looking Ahead
Following these successful approvals, CS MEDICA is positioned to leverage its growing momentum and expand its product portfolio across Asia. The insights gained from these regulatory achievements are critical to easing the pathway for future registrations in other key markets, such as China. With a strong foundation and a proven strategy, CS MEDICA is committed to providing innovative medical solutions that meet the diverse needs of patients worldwide.