Global Regulatory Services

Our specialized services encompass a broad range of regulatory matters, ensuring your medical device is compliant with international standards. Our key services include:

  1. FDA Assistance:
    • We offer thorough guidance throughout the FDA 510(k) clearance and Premarket Approval (PMA) process, ensuring your medical device meets all relevant U.S. regulations.
  2. Medical Device Regulation (MDR) Compliance for the European Union:
    • We provide expert support in navigating the intricate MDR landscape, helping you to understand and comply with these crucial regulations.
  3. Pharmaceuticals and Medical Devices Agency (PMDA) Compliance for Japan:
    • Our team offers in-depth assistance with PMDA regulations, ensuring your product meets the high safety and performance standards required for entry into the Japanese market.
  4. Medical Device Control Office (MDCO) Compliance for Hong Kong:
    • We facilitate understanding and compliance with the MDCO regulatory framework, enabling successful product registration in Hong Kong.
  5. Regulatory Compliance for South Asian Countries:
    • We also offer regulatory support for medical devices intended for markets in South Asia, including but not limited to India, Singapore, and Malaysia. This support includes understanding and adhering to local regulations, as well as assistance with product registration.
  6. Global Market Access:
    • Beyond specific regions, we offer guidance for other key markets worldwide. We help navigate the diverse and complex international regulatory landscapes, ensuring your medical device is compliant no matter where your business takes you.

Our team stays abreast of regulatory changes, ensuring we offer up-to-date advice and can help our clients adapt as required. We work closely with our clients at every step, providing the most effective regulatory strategies tailored to their specific needs.