China is one of the world’s fastest-growing markets for medical devices. The China medical devices market size was valued at USD 40.31 billion in 2024 and is expected to grow to USD 82.02 billion by 2032, with a projected CAGR of 9.4% during the forecast period. This growth is driven by an aging population, expanding hospital systems, and continued investment in healthcare innovation. For global manufacturers, the market presents major commercial opportunities, but also strict regulatory requirements.
Entering the market requires careful preparation and full compliance with the National Medical Products Administration (NMPA) framework. Companies must understand classification rules, documentation standards, testing requirements, and language expectations before submitting a registration application. Every file must be complete, accurate, and translated into simplified Chinese using approved terminology to avoid delays and rejections.
This guide explains how medical device registration works in China, outlining the key agencies involved, classification rules, and a step-by-step overview of the registration process. It also emphasizes how professional translation and localization support can help streamline your submission and reduce the risk of regulatory delays.
Understanding the Regulatory Framework in China
The National Medical Products Administration (NMPA), formerly known as the CFDA, is China’s primary authority responsible for regulating medical devices, in vitro diagnostics (IVDs), and pharmaceuticals. It manages product classification, clinical evaluation, testing, and post-market surveillance. Local NMPA branches at the provincial level handle applications from domestic manufacturers, while the central NMPA reviews imported devices.
Anyone trying to register medical devices in China must be familiar with device classification, submission pathways, and the documentation rules and requirements.
1. Medical Device Classification System
Correct classification is the first step in the China medical device registration process. Misclassifying a device can delay approval or require resubmission.
China categorizes medical devices into three classes based on risk level:
- Class I: Low-risk devices, such as surgical gloves or tongue depressors. Their safety and effectiveness are maintained through routine procedures.
- Class II: Medium-risk devices, like infusion pumps or diagnostic ultrasound systems. These need additional verification and testing.
- Class III: High-risk or life-supporting devices, including pacemakers or implantable stents. They undergo the strictest technical review and clinical assessment.
2. Domestic vs. Imported Devices
Domestic manufacturers submit applications through the provincial NMPA branch. Imported devices, however, must be registered directly with the central NMPA in Beijing, and the foreign applicant must appoint a local Authorized Agent in China to serve as their legal representative. This agent handles communication, submission, and post-market compliance.
3. Language and Documentation Requirements
All application documents, including technical files, labeling, instructions for use (IFU), and clinical data, must be submitted in simplified Chinese. Translations must comply with China’s medical device regulations and use standardized regulatory terminology.
Reviewers evaluate clarity, accuracy, and consistency—not just literal translation. Incorrect or inconsistent terminology often leads to requests for clarification, which extends review timelines. Many companies partner with professional medical device translation providers to ensure consistency and compliance.
The 7 Steps to Register a Medical Device in China
Step 1: Confirm Device Classification
Before starting registration, confirm the correct device classification using the NMPA’s Medical Device Classification Catalogue. If the product isn’t listed, you may need to submit a classification application for official determination. This step defines the scope of testing, clinical requirements, and documentation you will need later.
Step 2: Prepare Technical Documentation
Once classification is confirmed, compile all required technical documentation, which generally includes the following:
- Device description, design drawings, and intended use
- Manufacturing process overview
- Quality management system (QMS) certificates (usually ISO 13485)
- Risk analysis and performance data
- Clinical evaluation plan
- Labeling and packaging design
All materials must meet NMPA formatting standards and be translated into Chinese. This phase often requires close coordination between the research and development team, regulatory affairs, and translation specialists to ensure the technical documentation is accurate, complete, and ready for submission.
Step 3: Conduct Type Testing in China
Before submission, imported Class II and Class III devices must undergo type testing at an NMPA-approved testing lab in China. The test report is mandatory for registration. Applicants provide product samples, technical data, and, if necessary, testing instructions in Chinese. This process can take 2 to 6 months, depending on device complexity.
Type testing verifies the device meets Chinese safety and technical standards, which may differ from ISO or FDA benchmarks. Planning early for testing and translation of protocols saves time and avoids repeat submissions.
Step 4: Complete Clinical Evaluation or Clinical Trials
The NMPA requires clinical evidence to prove that the device is safe and effective for its intended use. For some low- and medium-risk products, literature reviews or clinical data from equivalent devices may suffice. For innovative or high-risk devices, however, local clinical trials in China might be necessary.
Sponsors need to obtain ethics approval, register the trial with the NMPA, and follow Good Clinical Practice (GCP). Clinical documents and patient materials must be in Chinese. Coordinating medical device translation services during this stage helps ensure consistency across consent forms, case report forms, and investigator documents.
Step 5: Translate and Prepare Labeling, IFU, and Packaging Information
Proper labeling is crucial for compliance. Under China’s medical device labeling rules, all labels, packaging, and instructions for use must be in simplified Chinese. This includes:
- Product name and model
- Manufacturing and expiry dates
- Manufacturer’s name, address, and contact information
- NMPA registration number (once approved)
- Storage and handling instructions
- Warnings, contraindications, and disposal information
Poorly translated labels are among the most common reasons for regulatory queries. Working with experienced translators familiar with technical and cultural nuances ensures accuracy and compliance.
Step 6: Submit the Registration Application to the NMPA
Once all documentation, testing reports, and translations are ready, the applicant or authorized agent submits the registration package to the NMPA. The submission typically includes:
- Application form and cover letter
- Technical documentation and test reports
- Clinical evaluation data
- Labeling and IFU in Chinese
- Proof of quality management certification
- Power of attorney and business license of the authorized agent
Upon acceptance, the NMPA issues a registration number and begins formal review.
Step 7: NMPA Review and Approval
The NMPA conducts a comprehensive technical and administrative review. For Class II and III devices, this process may include expert panels or requests for additional information.
Typical review timelines:
- Class I: Filing only (approximately 1 month)
- Class II: 6–12 months
- Class III: 12–24 months, depending on clinical complexity
Once approved, the NMPA issues a Medical Device Registration Certificate, valid for five years. Renewals must be filed six months before expiration, and require updated documentation and post-market data.
Conclusion
Successful entry into China’s medical device market requires careful preparation, accurate documentation, and compliance with NMPA standards. Each stage, from classification to labeling, must follow strict regulatory and language requirements.
EC Innovations supports medical device manufacturers with regulatory translation and localization throughout the registration process. We ensure documentation, labeling, and clinical materials meet Chinese regulatory standards to help reduce risk and accelerate approval. Learn more about our medical device translation services or contact us today.
