China Medical Device Registration and Device Classification

In China, medical devices and IVDs are supervised by the National Medical Products Administration (NMPA). To ensure the safety, effectiveness and quality of medical devices, NMPA strictly regulates the entire life cycle of them from registration to post-market sales.

About Us

Entering China's market is challenging, but our company has extensive registration experience. We are committed to helping you handle all compliance affairs of medical devices or IVDs before listing in China, including classification and registration, and support your products to obtain supervision approval as soon as possible.

China Medical Device Classification

Based on the risk level, according to factors such as expected use, mechanism, structural characteristics, and use pathway, NMPA divides medical devices and IVD products into three categories, as shown in the table below. 

Different levels of medical device products, their registration, filing, licensing procedures and requirements are different. Therefore, it is very critical to determine classification before registration and related licensing applications.

• Class I is the devices for which the implementation of conventional management can ensure their safety and effectiveness, such as surgical equipment, scraping board, medical X-ray film and surgical clothes.
• Class II is the devices that require strict control and management to ensure their safety and effectiveness, such as medical suture needles, blood pressure meters, thermometers and electrocardiograms.
• Class III is the devices that require special measures to strictly control and management to ensure their safety and effectiveness, such as implanted pacemakers, corneal contact mirrors, artificial crystals, ultrasonic tumor focusing knife, hemodialysis device and implantation equipment.

China Medical Device and IVD Registration

Before selling in China, companies must register their devices with the NMPA, and the NMPA reviews all application documents and test data strictly.

Class I devices implement product filing management, while Class II and Class III devices implement product registration management. Applicants of Class I devices submit information for filing, and applicants of Class II and Class III devices are subject to review before being granted a certificate of registration.

Common Questions Regarding China's Medical Device Registration and Approval Process

• Do foreign manufacturers selling devices in China need local agents?

Overseas applicants should designate corporate legal persons as agents to handle relevant medical device registration and filing matters.

• How long does the NMPA registration review take?

The time of registration may vary by device and classification.

• Do you need to prepare clinical data?

For most Class II and Class III devices, the clinical evaluation report that conforms to the NMPA guide is an indispensable document in the application materials. If the clinical evidence is insufficient, the manufacturers will be required to perform expensive and time-consuming clinical trials. For more detailed requirements, please search the NMPA website.

• Will NMPA check the medical devices on-site?

NMPA not only has a strict regulatory approval process, but also post-marketing supervision has become stricter in recent years. If on-site inspections do not meet the requirements, the manufacturers must rectify within a time limit.

Our Services

Our company has rich NMPA registration experience. The services we provide will be targeted, reasonable, and fast according to the specific situation of your products, no matter what difficulties you encounter with registration. You can solve the following problems with us.

✓ Regulation interpretation and consultation.

✓ Determine your product classification.

✓ Formulate the optimal strategy approved by NMPA, as well as a variety of optional plans.

✓ Write the registration application and technical requirements documents. NMPA requires documents to be written in Chinese, and we have a number of native language experts.

Our company provides professional China medical device registration and classification services for global manufacturers. Our experts communicate closely with NMPA and have deep regulatory knowledge. Our professional service team will provide great help with your medical device entry into China's market. If you need help or have a question, please feel free to contact us for more details.