In the global medical device market, regulatory certifications such as CE and FDA play a critical role in determining product reliability, patient safety, and international acceptance. For hyaluronic acid (HA) injections, which are widely used for joint health and osteoarthritis treatment, certifications are not just formalities—they are essential for market entry.
FDA (U.S. Food and Drug Administration) approval is mandatory for products entering the United States market. It requires extensive clinical trials, strict documentation, and high regulatory costs.
CE (Conformité Européenne) certification, on the other hand, is recognized across Europe and in many other regions worldwide (Middle East, Asia, Africa, and Latin America). It focuses on product safety, quality management systems, and compliance with EU directives.
Although Orthosyn Medikal does not currently hold FDA approval, our CE-certified hyaluronic acid injections fully comply with international safety and quality standards.
Global Acceptance: CE certification is widely recognized outside of the U.S., including in the EU, Middle East, Asia, and Latin America.
Market Access: In many countries, CE certification is enough to register and commercialize medical products.
Patient Safety Assurance: CE ensures that our HA injections meet rigorous European Union standards for safety, biocompatibility, and clinical performance.
Certified Quality: All Orthosyn HA injections carry CE certification.
Reliable Supply: We maintain high stock capacity, ensuring fast delivery worldwide.
Trusted by Distributors: For importers and hospitals outside the U.S., CE certification guarantees smooth regulatory approval and market entry.
While FDA approval is essential for the U.S. market, CE certification is more than sufficient for the vast majority of global markets. Orthosyn Medikal proudly provides CE-certified hyaluronic acid injections, giving distributors and healthcare providers the confidence to deliver safe and effective treatments for joint health.