MEDIGANT
NMPA Regulatory Expertise

CRO Registration
Services

Navigate China's medical device regulatory landscape with confidence. We handle the complete NMPA registration process so you can focus on your product.

NMPA Registration Framework

China's National Medical Products Administration (NMPA) classifies medical devices into three categories based on risk level. Understanding the correct classification is the critical first step.

Class I

Low-risk devices. Filing-based registration with simpler documentation.

Class II

Moderate-risk devices. Full registration with technical review and possible clinical data.

Class III

High-risk devices. Comprehensive review including clinical trials.

Registration Process

Step 1

Product Evaluation

Assess product classification, applicable standards, and registration pathway under NMPA regulations.

Step 2

Documentation

Prepare technical dossiers, test reports, clinical evaluation materials, and labeling compliance.

Step 3

Submission

File registration application with NMPA and manage all procedural requirements.

Step 4

Review Follow-up

Track review progress, respond to deficiency letters, and coordinate supplementary submissions.

Step 5

Certification

Obtain NMPA registration certificate and prepare for market launch.

Our Advantages

Expert Team

Regulatory specialists with deep experience in consumer medical device classifications.

Proven Track Record

Dozens of successful registrations across multiple device categories.

Efficient Timelines

Streamlined processes that minimize registration duration without compromising quality.

End-to-End Support

Continuous guidance from initial evaluation through post-market compliance.

Registration Success Stories

Due to confidentiality agreements, brand names are not disclosed.

Health Monitoring Device

Class II registration completed in 8 months; product now sold across 3 major e-commerce platforms

Home Diagnostics Kit

Successfully navigated regulatory changes during renewal; zero market disruption

Personal Care Device

First-time registration approved on initial submission with no deficiency responses required

Frequently Asked Questions

How long does the registration process typically take?
Timeline varies by device classification. Class I devices may take 1-3 months, Class II typically 6-12 months, and Class III can take 12-24 months. We provide detailed timeline estimates during the initial evaluation.
What documents do we need to provide?
Core documents include product technical specifications, test reports from accredited labs, clinical evaluation data (when required), manufacturing quality management system certificates, and product labeling. We provide a detailed checklist during the evaluation phase.
Do you handle clinical trials?
For devices requiring clinical data, we coordinate with qualified clinical sites in China and manage the entire clinical evaluation process, including trial design, site selection, and regulatory submissions.
What happens after we get the registration certificate?
We support post-registration compliance including annual reporting, registration renewals, change applications, and ongoing regulatory monitoring to ensure your product stays compliant in the Chinese market.

Start Your Registration Journey

Let us evaluate your product and provide a clear regulatory pathway for the Chinese market.

Request a Consultation