Medical Device Import & NMPA Registration in China for US, UK & Global Manufacturers

Western medical technology leads the world – and China is a massive market. NMPA registration by class, clinical evaluation and quality system review are mandatory. We guide manufacturers through the full approval process.

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What We Cover for Medical Device Exporters

NMPA medical device registration support (Class I/II/III)
Clinical evaluation and testing coordination
Quality management system documentation
NMPA audit preparation and support
Post-market surveillance and compliance monitoring
Ongoing regulatory monitoring and renewal support
Medical device compliance training and advisory

How It Works

A simple 6-step process to get your brand into China

1

Free Consultation

Tell us about your products and goals. We assess your compliance needs at no cost.

2

Custom Plan

We design a tailored compliance roadmap specific to your products and timeline.

3

Full Execution

Our team handles registrations, filings, certifications, and all documentation.

4

Compliant Delivery

Your products are fully compliant and ready for the Chinese market.

5

Quality Assurance

We verify all documentation and certifications meet Chinese regulatory standards.

6

Market Entry Support

Ongoing compliance monitoring and regulatory updates to keep your business running smoothly.

Why Choose Us

Deep Expertise

Years of hands-on experience in China's import regulatory landscape.

End-to-End Service

From initial assessment to final compliance: we handle everything.

Transparent Pricing

Fixed fee structure with no hidden costs or surprises.

Expert Team

Years of hands-on experience helping international brands succeed in China.

Medical Device Export FAQs

Common questions about exporting medical devices to China.

How are medical devices classified in China?
Medical devices are classified into three classes: Class I (low risk, filing), Class II (medium risk, registration) and Class III (high risk, strict registration with clinical evaluation).
Learn More → CCC Certification
How long does NMPA registration take?
Class I takes 3-6 months, Class II 6-12 months, and Class III 12-24 months depending on clinical requirements. We expedite via complete, accurate submission.
Learn More → CCC Certification
How do I get an import license for medical devices in China?
First obtain NMPA registration (Class I filing or Class II/III registration), then apply for the import license. We handle both steps for you.
Learn More → CCC Certification
What labeling is required for imported medical devices?
Imported devices need Chinese labels with product name, registration number, instructions and warnings per NMPA labeling rules.
Learn More → CCC Certification
Can medical devices be sold through cross-border e-commerce?
Generally no. Medical devices are excluded from the cross-border catalog and require regular import approval. We advise on the correct route.
Learn More → CCC Certification
Is there a fast track for innovative medical devices?
Yes. NMPA offers a fast track for innovative devices with priority review and consultation. We assess whether your product qualifies for the innovation pathway.
Learn More → CCC Certification

Free Compliance Assessment

Tell us about your products and we'll provide a personalized compliance roadmap.

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Need This Service?

Get a free compliance assessment tailored to your products.

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