Entering the China Market: Clinical Trial vs Clinical Trial Exemption

Clinical trials and clinical evaluations are commonly used to assess the safety, clinical performance, and effectiveness, as well as to verify the intended purpose of the medical devices. It incorporates clinical trial data, literature reviews, and clinical experience data such as post-market surveillance data. Manufacturers must continuously update clinical evaluation reports based on post-market clinical and non-clinical data throughout a medical device’s lifecycle.

This article will cover the key aspects of when a medical device needs a clinical trial and when a clinical trial exemption is applicable in China.

Does Your Device Require a Clinical Trial in China?

Like the EU and the US, not all medical devices require local-based clinical trials. According to the Announcement No. 73 of 2021, clinical trials are generally required for:

• High-risk Class III medical devices with no equivalent product that has been approved in China

• Medical devices with new or significantly modified technologies, as well as innovative technologies

• New types of medical devices that are not considered high-risk product category

• Medical devices with insufficient non-clinical studies and/or existing clinical data to demonstrate the Basic Safety and Essential Performance

Exemptions from Clinical Trials

China’s National Management Product Administration (NMPA) published a list of Class II and III medical devices that can be officially exempted from hosting a clinical trial in China. This also implies that instead of a clinical trial, the applicant needs to prepare a comparative analysis to demonstrate equivalence between the medical device in question and the product described in the Product Catalogue of Clinical Trial Exemption. The product catalogue is updated every two years; the current version was published in 2023.

Manufacturers of high-risk Class III medical devices and new device types can consider omitting clinical trials if the following criteria are met and it complies with the Basic Safety & Essential Performance:

• The medical device in question has undergone a design change from a predecessor and has not acquired marketing authorization in China. 

  Applicants can use existing non-clinical research data, clinical trial data of the predecessor product, and overseas clinical data of the medical device in question to demonstrate compliance with Basic Safety and Essential Performance

• The predecessor product has been approved in China, and the medical device in question is the successor after the design change. 
  Similarly to the previous point, clinical relevant data from both the predecessor and medical device in question can be applied here.

• The overseas clinical data of the medical device in question fulfills the requirements of “Technical Guidance for Acceptance of Overseas Clinical Trial Data for Medical Devices” published under Announcement No. 13 of 2018.

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