China Medical Device Approval Tracker: Imported Class II & III Devices

The China medical device approval tracker consolidates NMPA-published approvals for imported Class II and Class III medical devices issued throughout the year. Updated monthly as new certificates are released, it provides manufacturers with a clear and current view of NMPA approval activity across key medical device categories in China.

Companies can use this China medical device approval tracker to:

Identify trends in China medical device approvals within their product category
Monitor NMPA medical device approval activity throughout 2026

Together, these insights help manufacturers prepare more effectively for China’s medical device registration process and anticipate the regulatory expectations associated with their device category.

Continue below for the interactive charts, or if you would like a copy of the Excel spreadsheet in English, contact Cisema today.

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2026 Imported Class II & Class III Medical Device Approvals in China

A clear view of year-to-date approvals is essential for companies evaluating market entry timing or assessing the regulatory landscape for their device category.

The visualization below compiles NMPA-published imported Class II and Class III medical device approvals issued in 2025.

2026 Approvals by Medical Device Category

This consolidated view offers a helpful foundation for understanding how different risk classes and device categories are progressing through the China medical device approval system during the year.

2026 Approvals by Import Source

The distribution of China medical device approval certificates by import source serves as a barometer for global trade participation in China’s healthcare sector, highlighting which regions maintain the strongest presence in China's medical device market.

2026 NMPA Innovative Medical Device Approvals

In addition to standard approvals, manufacturers may also benefit from tracking activity under the NMPA Innovative Medical Device pathway, which provides priority review for technologies demonstrating meaningful innovation or significant clinical value.

2026 Innovative Approvals by Medical Device Category

These NMPA innovative medical device approvals highlight the medical device categories most frequently benefiting from expedited review, offering useful context for manufacturers evaluating whether their own innovations align with NMPA criteria for priority pathways.

2026 Innovative Approvals by Import Sources

Tracking the origin of innovative approvals reveals how effectively foreign-developed technologies are accessing China’s priority pathways.

Registering Medical Devices in China

With an understanding of how imported Class II and Class III medical device approvals are progressing in China over 2025, the next step is for foreign manufacturers to translate that awareness into a practical registration strategy that aligns with NMPA expectations.

To turn insight into action, Cisema provides end-to-end assistance throughout the China medical device registration process, helping companies navigate the requirements that shape every imported medical device submission.

This includes:

Assessing medical device classification
Preparing and reviewing technical documentation for NMPA submission
Coordinating China type testing with designated laboratories
Acting as a China legal agent
Managing renewals, change filings, and post-approval compliance obligations

To take the next step, explore Cisema’s medical device registration services in China or get in touch with a regulatory specialist today.

Further Information

Glossary of Key Terms for China Medical Device Approvals

This glossary summarizes essential terms used in the medical device approval tracker to help manufacturers interpret NMPA data accurately.

Imported Medical Device

A device manufactured outside mainland China and registered domestically through a designated legal agent.

Innovative Device Designation

A special NMPA pathway for products demonstrating breakthrough technology or significant clinical value. Learn more about China’s innovative device designation.

Legal Agent

The required in-country representative for all imported medical devices in China. This entity handles confidential information between the manufacturer and the authorities and takes on post-market responsibilities. Learn more about China Legal Agent services.

NMPA (National Medical Products Administration)

China’s regulatory authority for medical devices, responsible for market approvals, inspections, post-market surveillance, and supervision of medical device certificates. Access the official NMPA website.

Registration Certificate

The official NMPA approval document defining the device’s name, intended use legal manufacturer, Chinese agent, and more.

Risk Classifications: Class I, II, and III

The NMPA assigns devices to risk categories that determine documentation, testing requirements, and depth of review:

Class I – Low-risk devices such as medical masks and blood pressure monitors
Class II – Moderate-risk technologies such as surgical instruments and syringes
Class III – High-risk devices subject to the most stringent evaluation