Medical device clinical trials are an important step in verifying the safety of a device, and the reliability of its trial results is directly related to its safety after it is put on the market. The quality of clinical trials is the key to clinical trials. By planning, identifying and evaluating quality risk factors in each link of medical device clinical trials, and exploring risk reduction countermeasures, we will help you establish and improve the medical device risk management quality system and achieve quality management throughout the clinical trial process.

Definition of Clinical Trial of Medical Device

      Clinical trial of medical device refers to the process of confirming the safety and effectiveness of medical devices (including in vitro diagnostic reagents) to be applied for registration under normal use conditions in qualified medical device clinical trial institutions. It is initially conducted in drug clinical trials. Trials, types of medical device clinical trials.

Which kinds of medical devices require clinical trials?​

      Medical devices are divided into three categories. Among them, the medical device products of Class Ⅰ only need to be registered and do not need to conduct clinical trials. When applying for medical device registration of Class Ⅱ and Class Ⅲ, clinical trials must be conducted, but if one of the following circumstances occurs, it is not necessary for clinical trials:

  • Medical devices with clear working mechanisms, finalized designs and mature production processes, or sharing the same general purposes with predicate devices that have been on the market and have been used clinically for many years without serious adverse event records;
  • Medical devices can be proven safe and effective through non-clinical evaluation;
  • By analyzing and evaluating data obtained from clinical trials or clinical use of its predicate medical devices, it can be proven that the medical device is safe and effective.

      In addition, the “Summary of the Catalog of Medical Devices Exempted from Clinical Trials” released by the National Medical Products Administration in December 2019 has 1,003 items in the catalog of medical devices and 416 items in in vitro diagnostic products, none of which are required to undergo clinical trials.

      Please contact us to obtain the “Summary of the Catalog of Medical Devices Exempted from Clinical Trials” and the “Summary of the Catalog of In Vitro Diagnostic Reagents Exempted from Clinical Trials” for free.

What is the process for conducting clinical trials of medical devices?

  • Preconditions:

Product inspection reports (self-inspection reports/third-party inspection reports) and animal test reports need to be completed.

  • Before the test (preparatory stage):

Compare information on similar products, search domestic and foreign literature and clinical data, determine the project execution time plan, complete statistical consultation, third-party service bidding (CRO, SMO, statistical companies, insurance service providers), screen research centers, and write preliminary research plans , hold a researcher plan discussion meeting, revise test documents (research plan, ICF, SD, CRF, etc.), and prepare test materials (test device, predicate device, CD-ROMs, temperature and humidity recorders, etc.).

  • In testing (implementation phase):

1. Center startup process

      Project approval review (preliminary communication, project acceptance), ethics review (submission of materials, ethics meeting, approval documents), contract signing (modification, signing), provincial administration filing of contract (signature version and stamped version of the contract), Genetic Office filing (filling in of declaration information, signature of cooperative company, approval by Genetic Office, results announcement), department kick-off meeting (handover of test materials, kick-off meeting, test training).

      2. Enrollment stage

      Screening visits, follow-up of visits; completion of the researcher’s original records, CRF form filling, adverse event reporting, device information collection, institutional quality control, CRA monitoring, and project audits.

      3. End of test:

      • Data Cleaning

      DM will question the data. CRC/researcher will reply the question. The data will be used for statistical analysis after cleaning and locking.

      • Statistical Analysis

      Statisticians analyze the data according to the statistical methods designed in the plan and issue statistical analysis reports.

      • Write a Summary Report

      Write a summary report based on the actual completion of the trial and statistical analysis.

      Close the Center

      CRA submitted the notification letter of center closure to the institution and ethics, sealed the application plan and summary report, and filed the trial documents (ISF/ investigator folder, subject files).