China Compliance for Medical Device Exporters

NMPA registration, import licensing, and regulatory compliance for medical devices entering China.

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What We Cover for Medical Device Exporters

NMPA medical device registration support
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?
China classifies medical devices into three classes: Class I (low risk, filing required), Class II (moderate risk, registration required), and Class III (high risk, strictest registration). Each class has different requirements and timelines.
Learn More → CCC Certification
How long does NMPA registration take?
Class I filing takes 2-4 weeks. Class II registration typically takes 6-12 months. Class III registration can take 12-24 months, including clinical evaluation. We manage the complete registration process.
Learn More → CCC Certification
Do I need clinical trials for medical device registration?
Clinical trials are required for many Class II and most Class III devices unless your product is on the clinical trial exemption list. We assess whether your device qualifies for exemption or requires clinical data.
Learn More → CCC Certification
What labeling is required for imported medical devices?
Medical device labels must be in Chinese and include: product name, model, manufacturer, registration number, indications, contraindications, storage conditions, and production date. Labels must be approved as part of the registration process.
Learn More → CCC Certification
Can medical devices be sold through cross-border e-commerce?
Generally no. Medical devices require NMPA registration for import into China. Cross-border e-commerce is not a viable channel for most medical devices. We help you navigate the full registration pathway.
Learn More → CCC Certification
Is there a fast track for innovative medical devices?
Yes. China has a priority review pathway for innovative medical devices that address unmet clinical needs. If your device qualifies, the review timeline can be shortened. We assess your device's eligibility for expedited review.
Learn More → CCC Certification

Free Compliance Assessment

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

We respect your privacy. No spam, ever.

Need This Service?

Get a free compliance assessment tailored to your products.

Free consultation → 24h response

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