Official Registration with ALIMS Serbia
The medical device FT.MDR.74, a 2% hyaluronic acid intra-articular syringe indicated for osteoarthritis and degenerative joint disorders, has successfully obtained medical device registration Serbia with the Medicines and Medical Devices Agency of Serbia (ALIMS).
Intra-articular hyaluronic acid injections are included among the therapeutic options evaluated in international osteoarthritis management guidelines.
FT.MDR.74 complies with Regulation (EU) 2017/745 (MDR), the most stringent European regulatory framework currently governing medical devices. MDR certification requires comprehensive clinical evaluation, structured risk management, and post-market surveillance systems. In today’s highly regulated global market, MDR compliance represents a critical competitive and strategic advantage.
FT.MDR.74: High-Viscosity 2% Hyaluronic Acid for Joint Treatment
FT.MDR.74 is a 2 ml prefilled syringe containing 2% sodium hyaluronate (20 mg/ml) obtained through non-animal biotechnological synthesis.
Its molecular weight range of 1000–1500 kDa ensures an optimal balance between viscosity and receptor interaction capacity within the joint environment.
Thanks to these characteristics, FT.MDR.74 works by:
- restoring the rheological properties of synovial fluid
- improving joint viscoelasticity
- contributing to pain reduction
- stimulating endogenous hyaluronic acid biosynthesis
When to Use FT.MDR.74 for Joint Treatment
FT.MDR.74 is indicated for:
- Knee osteoarthritis (gonarthrosis)
- Degenerative joint conditions
- Post-traumatic joint disorders
The recommended protocol consists of an initial 3-week cycle (one injection per week) followed by maintenance sessions when clinically appropriate.
Clinical Evidence
Clinical efficacy was assessed using the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index), an internationally validated questionnaire measuring pain, stiffness, and physical function in osteoarthritis patients.
Results demonstrated:
- Symptom reduction in 95% of cases
- Complete remission in 25% of patients over 42 years of age
- Significant improvement in pain, stiffness, and joint function
These findings confirm the effectiveness of intra-articular viscosupplementation with FT.MDR.74 in osteoarthritis management.
Strategic Impact of Registration in Serbia
The medical device registration Serbia strengthens our presence in Eastern European and Balkan markets.
Inclusion in the official ALIMS registry allows us to:
- Accelerate commercial distribution
- Operate through authorized regulatory channels
- Streamline future product registration procedures
The medical device registration Serbia represents an important milestone in the international consolidation of our intra-articular device portfolio.
We are certified manufacturers of medical devices, dietary supplements, cosmetics, and aesthetic medicine solutions.
We offer FT.MDR.74 ready to market or available in private label format, with full regulatory and technical support
