With the increasing tightening of global medical device regulation, overseas companies entering the European and American markets need to meet not only the complex pre-market approval requirements, but also deal with stringent Flying Inspection (No Notice Inspection) and Post-Market Surveillance (PMS). There are significant differences in regulatory logic, inspection methods and penalties between US FDA and EU MDR/IVDR.
What is FDA (U.S. Food and Drug Administration)? The FDA regulates the safety and effectiveness of medical devices in the United States. For most devices, manufacturers must submit a 510(k) to prove that their product is safe, effective, and substantially equivalent to an existing approved device.
What is MDR (Medical Device Regulation)? MDR is the European Union’s regulation for medical devices, replacing the former MDD (Medical Device Directive). It has stricter requirements for clinical evaluation, post-market surveillance, and technical documentation to ensure higher patient safety and transparency.
Navigating both FDA and MDR is complex—but critical. At Joytech, we’ve built a robust global compliance system to help our business partners meet these demanding standards with confidence. Whether you’re expanding to the U.S. or entering the EU under MDR, our certified products, technical documentation, and regulatory expertise are here to support you.
What We Have?
At Joytech, we’ve established a strong regulatory foundation to empower our partners globally. Joytech has built a comprehensive and forward-looking compliance framework that meets global regulatory requirements across major medical markets.
FDA 510(k) Clearance
Joytech has long established a strong presence in the U.S. market, with all of our core product lines already FDA cleared and actively supplied to global partners. Building on this certified foundation, we continuously invest in product innovation and regulatory renewal to meet evolving clinical needs and partner-specific project demands.
In 2025, we expanded our FDA portfolio with several new certifications:
Tubeless upper arm blood pressure monitors — offering enhanced portability and user experience.
Large-arm digital BP monitors (DBP‑6186 / 6286B) — designed for extended arm sizes (40–56 cm), with Bluetooth options.
Compressor nebulizers (NB‑1100 to NB‑1103) — FDA-cleared under Product Code CAF, supporting reliable respiratory therapy at home or in clinics.
EU MDR Certification
Joytech is among the first Chinese manufacturers to achieve EU MDR certification under the new regulation. In April 2022, we received our initial MDR certificate from TÜV SÜD, covering products such as digital thermometers, infrared thermometers (ear & forehead), breast pumps, and non-invasive blood pressure monitors—marking the first MDR approval in China for several categories including electronic thermometers and breast pumps.
Since then, we have continued to expand our MDR-certified portfolio annually. By October 2023, all new-generation blood pressure monitors and thermometers had received CE (MDR) approval. As of February 2025, our fourth batch of certified products includes:
This ongoing expansion reflects Joytech’s deep commitment to compliance, product innovation, and regulatory excellence. Our full product lifecycle—design, testing, manufacturing, documentation, and post-market surveillance—meets Europe’s most rigorous standards, empowering our partners with certified, ready-to-market solutions across the EU.
Other Regulatory Standards
Our manufacturing processes are certified under ISO 13485 and MDSAP, meeting the regulatory needs of the U.S., Canada, Australia, Japan, and Brazil.
Also, Joytech products also conform to NMPA (China), RoHS, and REACH directives, meeting safety, environmental, and documentation standards across Asia and the EU.
What It Means for Our Partners？
Working with Joytech means more than just sourcing a product—it means gaining a strategic partner who understands the complexities of international compliance.
v Lower regulatory risks and costs – Our ready-to-go certifications and experience with global audits reduce the burden on your local registration process.
v Faster market access – With pre-certified devices, you can launch in your target regions with greater speed and fewer delays.
v Customized technical and clinical support – From technical documentation to clinical data, our in-house regulatory team offers tailored support to meet your country-specific requirements.
v Proven quality and audit readiness – Our quality system has passed multiple third-party audits, and our documentation is always kept audit-ready, ensuring transparency and efficiency.
CONCLUTION: As regulations evolve, so will we. Joytech is committed to continuously expanding its global compliance roadmap with certifications such as FDA and MDR—ensuring our partners have uninterrupted access to certified, high-quality medical devices in regulated markets.
We already hold certifications across major global regions, including North America, the EU, Asia, and beyond.
Want to know if we’re certified in your market?
Looking for a regulatory-ready OEM/ODM solution?
Connect with our team today to explore product certification details, technical documentation, and tailored solutions for your project. With Joytech, compliance becomes your competitive advantage.
