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When a Clinical Study Shall be Considered in China

Stephanie (Xing) Huang „Wir unterstützen unsere Kunden in China und im Ausland mit hohen Qualitätsstandards, beschleunigen Ihre Marktzulassung und stellen die Einhaltung lokaler Anforderungen sicher. In unserer Rolle als China Agent trennen wir die regulatorische Funktion von der Vertriebsfunktion und managen professionell die Zulassung vor dem Markteintritt und die Aktivitäten nach dem Markteintritt.“

When a Clinical Study Shall be Considered in China

Although NMPA issued a guidance document, "Decision-making Whether to Carry out Medical Device Clinical Trials Technical Guidelines," in 2021, some manufacturers are torn between 'to do' or 'not to do' to make up their minds. This blog is to help further interpret some key points to decide on the approach.
 
First, the decision-making guideline aims to help both domestic and foreign medical device manufacturers determine whether the intended products shall plan clinical studies. The scope is for class II and class III devices. Class I and IVDs products are not included. From a strategic consideration: if the existing clinical evidence, such as clinical evaluation reports used for CE/FDA approval, the literature search, post-market data, or bench testing data could be collected to prove its safety and effectiveness, the time to place the product into the market eventually would be significantly shortened and less costly. 

Secondly, the guideline points out that some devices are subject to considering a clinical study:

  1. High-risk implantable devices with potential population differences.
  2. Moderate-risk devices, where the existing clinical evidence may not be strong enough to prove the safety and performance. The authority may co-consider the product’s intended use, technical and biotechnical characteristics, and existing research data to decide if a study is necessary.
  3. A completely new/innovative device in China in terms of intended use and technical and/or biological characteristics without a predicate device, although not high-risk, may also be requested to perform a clinical study. 

Thirdly, some devices may be exempted from clinical study. One example is where the previous generation of the intended product has not been approved in China and has a design change; however, the manufacturer can prove that the submitted products comply with the basic principles of safety and performance through non-clinical research data, clinical study data from the previous generation, and overseas post-market data to close the gaps. The non-clinical data may include bench testing, computer simulation tests, animal tests, etc. This principle also applies to products for which previous generations are approved in China. Or, the manufacturer may provide overseas clinical trial data of the intended product in accordance with the requirements of “Technical Guidelines for Accepting Overseas Clinical Trials of Medical Devices.” Or, low-risk device which has present clinical and non-clinical research data.

Clinical evaluation process
A standard clinical evaluation process may start by identifying the essential performance, collecting and analyzing the clinical data to generate the result by a scientific method, and proving the device’s safety and performance in the end. 



Figure 1. Schematic overview of the clinical evaluation process

In addition to the decision-making guideline, the technical review authority (CMDE-center for Medical Device Evaluation) also publishes a series of clinical evaluation recommended pathways as a supplementary tool to help manufacturers further determine a proper choice. The pathway provides a direct “yes/no” route to determine if the clinical trial would be expected following the order of China classification catalog categories. 
The medical device clinical investigation decision flowchart below may help you to have a proper assessment.