Main Certifications
510(k) – FDA (USA)
The 510(k) is an authorisation issued by the US Food and Drug Administration, which is required to market medical devices such as pre-filled syringes. It demonstrates that the product is safe and performs comparably to devices that have already received FDA clearance. In addition to granting 510(k) clearance, the FDA also regulates and monitors the entire manufacturing process to ensure that products comply with stringent health and safety standards—standards that are essential for ensuring patient protection
MDR (Medical Device Regulation) in Europe
This is the European regulation governing the manufacture and marketing of medical devices. Compared to previous directives, the MDR imposes significantly stricter requirements and ensures a consistently high level of quality, safety, and transparency throughout the entire supply chain
What Does This Mean for Distribution?
- Guaranteed Compliance: Distributors can rely on products that comply with international standards, facilitating entry into global market
- Reliability and Traceability: The presence of these certifications ensures transparency, allowing for efficient management of audits, checks, or recalls
- Simplified Logistics: Products certified in multiple markets support the optimization of the distribution chain and enable a rapid response to diverse customer needs
Safety and Compliance at the Service of Distribution
Certified pre-filled syringes are a guarantee of safety, quality and regulatory compliance not only for manufacturers but also for distributors. Thanks to international standards such as 510(k) and MDR, the market can rely on products that are reliable, traceable, and ready to meet the demands of the global market with efficiency.
