,Freyr’s Capabilities
Want help with China medical device registration? Freyr can help you with NMPA medical device Regulation and more.
WHY FREYR?
Quality Benchmarks and Accelerators
ptimized Cost Benefits
One Stop Regulatory Shop
Strategic Regulatory Partnership
Combinations Improvement Initiative
ISO Certified Regulatory Practices
Global Regulatory Intelligence Network
Get seamless market access with Freyr as your China NMPA agent. Freyr represents many global Medical Device company as China Agent for NMPA registration.
Meet our Regulatory Experts
Summer Xia
Associate Director
With over 20 years of experience, including 15 years in medical device regulatory affairs, Summer has excelled in navigating both pre-market and post-market requirements. Her expertise has been instrumental in guiding numerous foreign and local manufacturing companies entering the Chinese market. Summer’s leadership has been demonstrated through her roles heading multinational Quality Assurance and Regulatory Affairs teams. She holds an MBA and is a certified Lead Auditor by BSI, enabling her to proficiently manage complex compliance landscapes.
Layla Tan
Specialist
With over 8 years of experience, including 5 years in the medical device industry, focusing on 2 years in medical device regulatory affairs. Layla has excelled in file submission and preservation both pre-market and post-market. She keep eyes on any change/update from NMPA and provides support for numerous foreign and local manufacturing companies entering the Chinese market.
Allan Zhang
Manager
With 10 years experience of medical device registration. Allan has rich experience in active and non-active medical device, guiding numerous foreign and local manufacturing companies and helping them to get more than 100 certificates approved by NMPA. He had participated in drafting CMDE guideline and industry standards. He can guide manufacture with fast and compliant registration strategy.
Book a meeting
with our Regulatory experts today to achieve swift compliance with all China Medical Device Regulations.
