,Advantages of Partnering with Freyr Solutions
Why should you choose Freyr to guide your medical device through the regulatory maze in China?
- Expert Regulatory Navigation
Our in-depth knowledge of China’s evolving regulations ensures smooth, hassle-free certification processes. - Tailored QMS Support
We customize the ISO 13485 certification roadmap to suit your medical device category and regulatory needs. - Proactive Mock Audits
With our detailed pre-audits, you can anticipate potential issues and fix them before the NMPA audit—reducing stress and avoiding delays. - China-Specific GMP Consulting
Our on-ground consultants offer personalized advice on China’s unique GMP regulations, helping you maintain seamless manufacturing standards. - Speed and Efficiency
With our fast-tracked solutions, get to market quicker and avoid costly delays.
Did You Know?
The NMPA’s March 2024 guidance introduces new clinical evaluation pathways for over 1,600 devices, raising the bar for compliance
Nearly 40% of all overseas manufacturers faced delays in 2023 due to non-compliance with updated China Medical Device Regulatory requirements.
The Medical Technology market in China is on a robust growth trajectory, with an impressive expected CAGR of 7.49% from 2024 to 2029.
A sizeable market volume of US$65.97 billion is predicted in 2029, a clear reflection of the wide-scale potential in the industry.
Our Key Services for Your Compliance Needs
![]()
Fast-Track QMS Certification
Our professionals make the ISO 13485 certification procedures easy when obtaining the updated Chinese requirements for quality management.
![]()
Mock Audits to Ensure Readiness
Mock audits used during the awareness creation phase offer time for you to note compliance issues without incurring the time and cost of actual audits.
![]()
China-Specific GMP Consulting
We provide specific assistance to assist you with understanding Chinese GMP consulting requirements and bringing your manufacturing and quality standards into compliance.
Stay Ahead of Regulatory Changes
With new device classification rules coming into effect in September 2024, and updated pathways for Class II and III devices, staying compliant is no longer a choice—it’s a necessity.
- Revised Clinical Evaluation Pathways: Over 1,600 devices now have new evaluation routes, and high-risk products may require additional clinical trials.
- Easier CER Pathways for Exempt Devices: Devices on the Clinical Exemption Catalogue can now follow simplified routes for Clinical Evaluation Reports (CERs).
Benefits of Usability Testing
Discover how Freyr Solutions' FDA-recommended usability testing can enhance your medical devices
- Validate device efficiency and effectiveness.
- Ensure seamless integration into user routines.
- Prioritize safety through rigorous testing protocols.
- Reduce user errors.
- Facilitate regulatory approval.
Experience seamless approval process for Human Factors compliance
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.
