China | Regulatory Market Profile

China Medical Device Regulatory Agencies

China Medical Device Regulations & Guidance

NMPA Medical Device Classifications

Medical Devices

The NMPA classifies medical devices into three classes:

Class I - Medical devices for which routine administration can ensure safety and effectiveness (registration is not required).

Class III - Medical devices that are implanted, pose a threat to the patient's health, or provide sustenance or life support.

Class II - Medical devices that require further controls to ensure safety and effectiveness.

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Rules for Classification of Medical Devices

Medical Device Market Requirements in China

Medical device registration is now valid for 5 years and is only required for Class II and Class III devices.

Overseas manufacturers:

Class II and Class III devices require proof that the device has been approved in its country of origin.

All product information and submissions must be provided in simplified Chinese.

A China-based agent is required to register imported medical devices.

Clinical trials are required for some Class II and all Class III devices. All high-risk devices must be evaluated in China and clinical trials conducted outside of China may be subject to additional review.

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Administrative Measures for Medical Device Registration and Filing (Order No. 47)

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Measures for the Supervision and Administration of Medical Device Operations (Order No. 54)

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Measures for the Supervision and Administration of Medical Device Production (Order No. 53)

Medical Device Post-Market Requirements in China

One of the major changes included in Order 739 of China’s medical device regulation was a new emphasis on the entire life cycle of a device. Order 739 requires a manufacturer to establish a quality management system and implement post-market surveillance and risk control plans.

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Order No. 739

China UDI Requirements

UDI Compliance

China currently requires UDI registration labeling for Class III devices only. It is expected that UDI labeling for Class II devices will be required in October, 2024 and for Class I devices in October, 2026 (these are estimates).

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State Drug Administration announcement on rules for UDI system for Medical Devices

Standards and Essential Requirements in China

The NMPA requires conformity to a specific set of standards based on their regulations, these are often called "Guiding Principles." Depending on the standard, your device may be either required to conform to the standard or it may be optional with a justification. They may closely resemble ISO and IEC standards, however, the NMPA may also add additional requirements to their standards.

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Notice of the Center for Device Evaluation on Issuing Technical Guidelines for the Compliance of Basic Principles of Medical Device Safety and Performance (2022 No. 29)

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Standards Guidance (IVD)

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Standards Guidance (Medical Devices)