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 around your products and timeline.

3

Full Execution

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

4

Compliant Delivery

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

5

Quality Assurance

We verify every document and certificate against Chinese regulatory standards.

6

Market Entry Support

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

Why Exporters Choose Us

Deep China Expertise

Specialist knowledge across China's import regulatory landscape – GACC registration, label standards, CCC certification and more.

End-to-End Service

From initial assessment to final compliance approval – one dedicated team handles every step.

Transparent Fixed Pricing

Clear fixed fees with no hidden costs – you know what you pay from day one.

Experienced Team

A hands-on team that has guided international brands into the Chinese market at every stage – no hand-offs, no guesswork.

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). The system mirrors FDA and UK risk tiers but with different evidence demands - we map your device to the right class.
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 for US and UK manufacturers.
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 US and UK manufacturers.
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 - we adapt US FDA and UK labeling formats.
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 US and UK manufacturers 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 - including innovations from the US and UK - 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?

Request a free compliance assessment tailored to your specific products.

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