Medical Devices Registration in China: What You Need to Know

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Introduction

In China, the Medical Device Registration and approval are managed by the National Medical Medical Devices Administration (NMPA) formerly known as the China Food and Drug Administration (CFDA). The State Administration for Market Regulation (SAMR) supervises and oversees the activities of NMPA.

As per NMPA, a Medical device is an instrument, equipment, appliance, IVD, calibrator, or materials and other similar articles, including necessary computer software. The Medical Device Registration process in china is decided based on the classification of medical device.

Classification of Medical Devices Registration in China

As per Decree No.15 of the CFDA, the classification of Medical Devices in China is done based on the risk involved in the medical device. There are three category of medical device class as below:

Class I Medical Device: Low-Risk Level, Safety, and efficacy can be managed through minimal management and supervision
Class II Medical Device: Moderate Risk Level, stricter oversight for safety and effectiveness.
Class III Medical Device: High-Risk Level, Rigorous assessment for maintaining the safety and efficacy of the device.

Process of Registration of Medical Devices in China

For Class I Medical Devices

Registration of medical device in China for Class I Medical Device, the agent submits the initial filing for records. The NMPA does not conduct a technical review specifically for Class I medical devices.

For Class II and Class III Medical Devices Registration process

Appointment of Chinese Agent: A local representative of China is required to act on a Medical Device Manufacturer.
Prepare Registration Dossier: Depending on the class of medical device, the technical dossiers are prepared and compiled for submission to the NMPA.
Develop a Clinical Evaluation Report (CER): Various clinical trials are to be performed on medical devices, according to the medical device class, clinical trials shall be conducted and reports are to be submitted. Clinical trials are typically required for Class II and III devices unless exempted. On May 19, 2022, China’s NMPA issued guidelines to help manufacturers decide between seeking a clinical trial exemption, using predicate device comparisons, or conducting full clinical trials.
Application Submission: After compiling all the necessary technical dossiers, the Agent applies for the registration of a medical device to the NMPA.
After that, NMPA conducts a technical review of the application submitted and if needed NMPA requests additional information or questions.
Application Approval & Issue of Certificate: After the technical review, the NMPA will approve the application and Issue the Certificate of Registration for the Medical Device.
Post-Market Surveillance: Any adverse events or changes in the Medical Device shall be recorded and reported to the NMPA. Further required, periodical audits and inspections shall be conducted by NMPA to ensure that Medical Device compliance is followed.

Required Documents for Medical Device Registration in China

Class I Medical Device Required Documents:

Medical Device Risk Management Document
Medical Device Technical File
Medical Device Testing Report
Clinical Evaluation Report
Key Manufacturer & Manufacturing Information
Medical Device Design File
Medical Device Labelling and IFU File
Quality Management File
Market Authorization Approval from the home country
Agent Authorization Letter
Self-declaration Letters

Class II & III Medical Devices Required Documents:

Medical Device NMPA Application Form
Quality Management File
Safety and Efficacy Documents
Medical Device Basic and Essential Information
Test and Performance Document
Manufacturing Site and Process Document
Clinical Evaluation Report
Medical Device Risk Management File
Medical Device Technical Specifications File
NMPA Certified Lab Testing Report
Artwork for the IFU and Medical Device Labelling File
Self-declaration Document

Timeline, Fees & Validity

Type of Device	Timeframe	Fees (RMB)	Validity
Class I Devices (Notification)	5 to 6 months	N/A	Till the Medical Device is in practice
Class II Devices (Registration)	15 to 32 months	210,900 to 308,800	5 Years
Class III Devices (Registration)	15 to 32 months	210,900 to 308,800	5 Years

Notes:

The time frame and fees for medical device registration in China vary based on the device class.
Class I devices follow a notification process with a relatively shorter approval time.
Class II and III devices require a more rigorous registration process, taking longer and involving significant government fees.
Medical device registration validity for Class I devices is unlimited, while the registration certificate for Class II and III devices is valid for 5 years.

At Maven Profcon Services LLP, we specialize in offering comprehensive regulatory consultancy services tailored for medical device manufacturers. Whether you require assistance with Quality Management Systems (QMS), ISO13485 certification, Country Registrations, USFDA 510k submissions, MDSAP, or EU MDR compliance, we are your trusted partner. Our dedicated team ensures a seamless and efficient path to regulatory compliance, providing all-encompassing support under one roof.

To connect with us and get your Medical device registered in China, please reach out to us through enquiry@mavenprofserv.com or call us at +91-7490017774 / +91 7940026222.