,Overview
China’s medical device market is expanding to an incredible degree, yet to enter this market requires ensuring compliance with necessary China Medical Device Regulations. This is one reason that product registration (PR) and local registration (LR) can jeopardize your success while competitor’s advance. Now is the time to act; least one loses this golden opportunity to capitalize on it.
At Freyr Solutions, we thoroughly understand all China National Medical Products Administration (NMPA) processes; thereby giving your products quick market access while being fully compliant. Avoid losing market share to competitors and establish yourself in one of the most promising markets for medical equipment in China.
Our Expert Regulatory Support Includes:
- Local Representation: We offer our clients a fast track to the China NMPA and thoroughly facilitate your transactions in the organization.
- End-to-End PR & LR Management: Starting from the document submission till compliance tracking we make each step very much regulated and processed almost negligible chance of rejection.
- Risk Classification Guidance: The regulatory environment can be complex but now, you can confidently search through Chinese Medical Device classifications and understand what exact approval processes your medical device in China will need to go through.
Why Speed Matters in China’s Medical Device Market
In 2023, global demand for inspections and audits in China rose by 3% year-on-year, marking a clear rebound in sourcing interest.
61% of US-based and 58% of EU-based businesses have already diversified their sourcing strategies, signalling intensified competition in the region.
The drive toward supply chain digitization, with 40% of businesses aiming for enhanced traceability and compliance, shows that time is of the essence. This means that any delay in medical device registration in China implies missing out on growth opportunities.
Our Key Services:
- Compliance and Testing Support
Be one step beyond your competitors and get professional advice on China medical device regulations to obtain all the necessary approvals for your product. - Document Preparation and Submission
We make sure all documents, like clinical data and quality certificates, are properly translated into Chinese and submitted to NMPA for review. - Post-Market Surveillance (PMS) Compliance
Our work isn’t done once registration is complete. We assist in your compliance by regularly monitoring and reporting to preserve your market status.
Why Freyr?
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Local Expertise
Our dedicated China team ensures that all China National Medical Products Administration (NMPA) requirements are fully understood, helping clients avoid the traps that too often lead to slow or stalled registrations.
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Tailored Solutions
No matter what you are dealing with—a highly regulated Class III device that requires registration or a Class I product that needs to be listed—we come up with a regulatory strategy suitable for your business.
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Proven Track Record
Our large number of successful registrations means you can depend on us to get the job done quickly in the competitive China medical device market.
Act Now to Secure Your Market Position. Contact Freyr Solutions today and ensure your products are first in line for China’s medical device market.
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.
