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Freyr’s China Market Medical Device Competencies
- Comprehensive China NMPA Regulatory and Submission Strategy
- Identification of Predicate Device for Substantial Equivalence Analysis
- Identification of Applicable Standards
- Gap Analysis as per NMPA Regulation and International Standards
- Compilation of All Sections of the Technical File in Appropriate Format
- Publishing of Technical Documentation
- Addressal of Review Deficiencies and Responses
- Liaising Services for Device Clearance
- Consultation Services for Addressing Deficiencies
- Establishment Registration
- Device Listing and Maintenance of Registration Database
- Device Lifecycle Management
Experience seamless approval process for Medical Device in China
With a team of seasoned Regulatory experts, we streamline the entire process to ensure compliance and efficiency.
Proven Success Story: How Freyr Enabled China Market Entry for a Canadian Innovator
![On-Time Submissions]( "On-Time Submissions")
The Challenge
Navigating China’s stringent NMPA Regulations for Class III ventilators.
![Proven Track Record]( "Proven Track Record")
The Solution
Local representation + seamless license transfer.
![Trusted Local Expertise]( "Trusted Local Expertise")
The Result
Faster approvals, compliant market entry.
Frequently Asked Questions
Freyr streamlines every step, from preparing NMPA submissions to post-market surveillance, ensuring compliance and reducing time to market.
Yes, Freyr specializes in Class III devices, offering expertise in predicate analysis, gap assessments, and seamless NMPA registration.
Local representation ensures compliance with Chinese Regulations. Freyr acts as your trusted representative to liaise with the NMPA and manage licensing.
Freyr combines global Regulatory expertise, in-depth knowledge of NMPA standards, and a proven track record of enabling faster, seamless market entry.
Timelines depend on your device's risk classification, but Freyr’s proactive approach accelerates approvals by eliminating delays.
Ready to Get Your Device Approved in China?
Don’t wait. Get your device registered quickly and approved seamlessly. Contact us now to ensure fast approval and efficient market entry.
Meet our experts
Summer Xia
Associate Director- Medical Devices, Freyr China
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 I- Medical Devices, Freyr China
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- Medical Devices, Freyr China
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.
Why Freyr?
Are you ready to register your medical device in China? Contact us today to ensure your medical device complies with all China medical device regulations and achieve a swift approval.
Celebrating Customers Success
Medical Devices
Registration and LR Support
Global
Freyr has been an indispensable partner in achieving rapid global scalability for our Software as a Medical Device (SaMD) business. As a startup, acquiring expertise in worldwide regulations is cost-prohibitive. Freyr's competitive pricing and tailored services allowed us to get that expertise at a fraction of the cost of full-time resources. Their team's responsiveness and adaptability to project priorities have greatly facilitated our progress. We recommend Freyr to any company seeking expert guidance and support in the medical device Regulatory domain.
Arie Henkin
VP - Quality and Regulatory, Australia -based, Leading SaMD Company
Medical Devices
Swiss Rep Services
Japan and Switzerland
I genuinely enjoy my time working with Freyr, and I view them as a truly valuable asset and extension to my own team. They are dependable and accurate, and their pricing is competitive. Beyond that, I won’t hesitate to collaborate with Freyr again.
Darren Mansell
Regulatory Affairs Manager, UK-based, Global Medical Device Design and Manufacturing Company
Medical Devices
Registration and AR Services
Malaysia and Indonesia
Freyr provides a reliable service with expertise across many countries. I can rely upon Freyr to provide the information necessary to make an informed decision before entering a formal scope of work agreement. Once a project is underway, the Freyr team acts professionally to execute the work with excellent communication of progress.
