Hyaluronic Acid (HA) injections have become one of the most in-demand products in orthopedics and sports medicine, as well as in broader joint health treatments. With a growing global market and increasing demand from hospitals and clinics, becoming a distributor of HA injections presents a profitable business opportunity. But what are the steps, requirements, and certifications you need to consider?
Rising demand: Osteoarthritis and joint degeneration are increasing globally, especially in aging populations.
Non-surgical treatment option: HA injections provide lubrication and cushioning in the joint, delaying or reducing the need for invasive surgery.
Wide applications: Commonly used in knee, hip, and shoulder osteoarthritis treatments, as well as in sports medicine.
Distributors should carefully evaluate the certification status of the HA injections they plan to import and sell.
CE Certification: In the European Union, Middle East, Asia, Africa, and many other markets, CE marking is the most widely recognized standard for medical device safety and compliance.
FDA Approval: Required in the United States market. FDA approval is highly specific and can take longer to obtain.
ORTHOSYN Medikal’s Position:
ORTHOSYN Medikal manufactures CE-certified hyaluronic acid injections. While our products do not carry FDA approval, the CE certificate is fully sufficient for registration and distribution in all non-U.S. markets, making it an ideal choice for distributors targeting Europe, the Middle East, Africa, Asia, and Latin America.
When working with a manufacturer, different distributor models may be offered:
Exclusive Distributor: One company per country with strong annual order commitments.
Regional Distributor: Limited to specific regions or states within a country.
Authorized Reseller: Multiple resellers with smaller order commitments.
ORTHOSYN Medikal supports distributors with flexible models depending on country-specific market dynamics and partner capacity.
Europe & Middle East: High demand due to aging populations and advanced orthopedic practices. CE-certified products are the main requirement.
Asia & Latin America: Fast-growing demand, with local authorities often recognizing CE as sufficient for registration.
Africa: Emerging markets with increasing imports of affordable CE-certified medical products.
Becoming a distributor involves more than just purchasing products. Hospitals and regulators often expect:
Regulatory documentation support for smooth registration.
Marketing and educational materials to promote the product locally.
Reliable logistics and stock capacity to ensure uninterrupted supply.
ORTHOSYN Medikal provides distributors with regulatory support, marketing tools, and a strong production capacity capable of supplying large orders consistently.
Becoming a distributor of hyaluronic acid injections is a high-potential opportunity in today’s medical markets. By choosing a CE-certified product such as those offered by ORTHOSYN Medikal, distributors can ensure compliance, gain fast access to non-U.S. markets, and build a profitable partnership in the expanding joint care segment.