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Problems and Suggestions for Medical Device Clinical Auditing in China


In conjunction with the problems audited by the CNDA for clinical trials of medical devices, China Med Device, LLC summarizes some common problems and put forward some suggestions.


  1. Clinical data inconsistency

Clinical trial protocols, informed consent and other documents are prepared before the start of clinical trials. Clinical trials are a complex process. In practice, it is inevitable to modify the programs, ICF and other documents. Some enterprises do not pay attention to this problem or due to the time constraints, they don’t submit the modified document for ethical review, or execute the new version of the document before the ethical review approval. These cause inconsistencies in the version or content of the files.

In response to this problem, we suggest that enterprises should pay attention to the ethical arrangements of each site when modify documents.  They should submit ethical review in time after revision to save time. The new version of the document can be executed after the ethical approval. At the same time, to avoid the inconsistency between the submitted data and the data stored in clinical trial site, it is necessary to verify the data before the end of the clinical trial.

  1. Untraceable subject or clinical trial sample

On June 1, 2018, the CNDA (predecessor of CFDA) issued the “Key points and principles of medical device clinical trial inspection (Draft for Comments)”. It specifies in the draft guideline that if the source of clinical trial data cannot be traced, it shall be deemed as an authenticity issue and the registration application will not be approved. The clinical trial data includes inclusion/exclusion criteria, main efficacy indicators, and important safety indicators, etc.

We suggest that the auxiliary inspection data should be traced to the system in the hospital LIS, PACS and other systems. The data of the original medical record should cover all the data in the CRF.

  1. Reuse of clinical trial samples

“Key points and principles of medical device clinical trial inspection (Draft for Comments)” defines that if samples are reused in clinical trials without clearly defined in the clinical trial protocols, it shall be determined as inauthenticity issues and the application will not be approved.

We recommend that if samples need to be reused during the clinical trial, it should be specified in the clinical trial protocol in advance. Sample reuse records should be retained during clinical trial implementation and described in the summary report.

  1. Inauthentic samples used for medical device clinical trials

Some companies use samples in clinical trials that are inconsistent with the products submitted for the application. For example, replace controlled medical devices with test medical devices to save costs during clinical trials, or replace test medical devices with controlled medical devices for better clinical trial results.

According to the “Key points and principles of medical device clinical trial inspection (Draft for Comments)”, it is defined that if the medical device or the in vitro diagnostic reagent is untrue, it is determined that there are authenticity issues. The registration application will not be approved. We recommend the company to use authentic clinical trial samples.


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About China Med Device, LLC

China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, RA, clinical evaluation, CRO, QA and post market compliance. We are experienced in handling innovation approvals and priority reviews. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Our management team has 100+ years of combined experience in medical device and IVD and has been involved with 1,000+ CFDA certificates and 250+ companies’ success.

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