China NMPA Regulatory Requirements for Medical Devices and IVDs

China’s Medical Device Market and Regulatory Requirements

China’s high demand for healthcare technology makes it an obvious target for manufacturers looking to expand their market portfolio. However, China’s medical device market is meticulously regulated. To meet China’s regulatory requirements, manufacturers need to budget time and resources for local testing and prepare to conduct clinical trials in China, which may be required for high-risk devices.

Regulatory authority

Medical devices sold or distributed in China are regulated by the National Medical Products Administration (NMPA) (formerly known as the China Food and Drug Administration (CFDA)). NMPA enforces regulatory requirements according to the Regulations on the Supervision and Administration of Medical Devices (State Order No. 739) as well as supporting regulations and announcements.

Device classification

Medical devices registered in China are classified into three tiers of increasing risk: Class I, II, and III. Classification is based on Decree No. 15, Rules for the Classification of Medical Devices, as well as NMPA’s Medical Device Classification Catalogue, which includes an extensive list of predicate (also called a “same-type device”) medical device categories, their descriptions, and corresponding classifications. Identifying a predicate and product code for your device is a critical step that will impact your regulatory pathway.

Registration process

All medical devices and IVDs need a Medical Device Registration Certificate (MDRC) from NMPA before distribution in China. Home country approval, such as an EU CE Mark or FDA 510k Clearance, is required for all imported medical devices. Class I medical devices are subject to a notification process that requires an application for administrative review. Class II and Class III medical devices require an application, full technical review, and product testing. Clinical data from local clinical trials may also be required. Clinical Evaluation Reports (CERs) may be accepted instead of local clinical trials depending on your device’s predicate and risk profile. Labeling must be submitted in Simplified Chinese.

Quality management system (QMS) requirements

Manufacturers must submit proof of a quality management system with their registration dossier, such as an ISO 13485 certificate. China has its own Good Manufacturing Practice (GMP) and may audit manufacturers of medium- and high-risk device manufacturers to these requirements, which align closely with ISO 13485. However, manufacturers may want to ensure their QMS meets China GMP requirements in preparation for a potential audit, particularly if the device is very high risk.

In-country representation

Device manufacturers without a physical presence in China must retain an in-country representative called a China Agent. The China Agent acts as a liaison between your company and the NMPA, submits your registration dossier, ensures compliance with post-market surveillance and incident reporting obligations, and is listed on your device labeling and instructions for use. You must also appoint an after-sale service agent, who manages technical support and servicing of your device. However, this role is distinct from the China Agent responsibilities.

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