- Are clinical trials necessary for medical devices to enter China?
According to the 2018 announcement on the latest “Catalogue of medical devices exempted from clinical trials” (No. 94, 2018) and “Catalogue of IVD reagents exempted from clinical trials”, when the product description conforms to the medical devices or IVD reagents of the specification on the list, clinical trials can be exempted, but the applicant for registration needs to submit a clinical evaluation.
- What is a clinical evaluation?
Clinical evaluation is one of the registration documents, which refers to the process in which the applicant validates whether the products meet use requirements or scope of application through information such as clinical literature, clinical experience data and clinical trials. For the products listed in the “Catalogue of medical devices exempted from clinical trials” (hereinafter referred to as “the Catalogue”), the registration applicant needs to submit the comparative data between the relevant information of the declared product and the contents mentioned in the Catalogue, as well as the comparison description between the declared product and the medical device listed in the Catalogue which has been approved for registration in China.
- Is it difficult to apply for clinical trials in China?
It was announced on April 1, 2019 that within 60 working days from the date of acceptance of the application for clinical trial approval and payment of the fee, under the premise that the contact information and mailing address are valid, if the comment from the Center for Medical Device Evaluation has not been received, the applicant can carry out the clinical trials.
- How to confirm the number of the case of clinical trials conducted in China?
If there is a national standard for the medical device, the national standard shall be followed. If there is no national standard, it is necessary to follow the “Guidelines for the design of clinical trials of medical devices”; through discussion with the clinical trial unit, the clinical trial scheme and case number can be formulated.
- How many kinds of clinical trials can be classified?
- Clinical trial use of a medical device: It verifies whether elements of the medical device, such as theoretical principle, basic structure and performance, can guarantee the safety and effectiveness in clinical use.
Scope: The medical device that has not yet appeared on the market, whose safety and effectiveness are yet to be confirmed. - Clinical verification of a medical device: It verifies whether the medical device is substantially equivalent to the main structure, performance and other elements of the product that have appeared on the market, and whether it has the same safety and effectiveness in clinical use.
Scope: The medical device whose similar product has appeared on the market, and whose safety and effectiveness are yet to be confirmed.
- Clinical trial use of a medical device: It verifies whether elements of the medical device, such as theoretical principle, basic structure and performance, can guarantee the safety and effectiveness in clinical use.
- What are the preconditions foe clinical trails?
- The product has the approved standard on the registration of the product or corresponding national and industry standards.
- The product has a self-test report.
- The product has a Product Type Test Report issued by a testing organization approved by CFDA and the Quality and Technology Supervision Bureau under the State Council, and the conclusion is compliance.
- The tested product is a medical device to be implanted into the human body for the first time, and there should be an animal test report on the product.
- What are the Key Points of the clinical trail program?
- Clarify test purpose, risk analysis, overall design, test methods and steps.
- Protection of the rights and interests of the subjects to the utmost degree: the safety and health of the subjects are the primary principles.
- The medical unit responsible for the clinical trials and the implementer jointly design and formulate the program, which is to be implemented upon approval by the Institutional Review Board.
- For Class III medical devices implanted or made with TCM theory that have not yet appeared on the market, the clinical trial scheme needs to be submitted to the medical device technical evaluation agency for reference.
- The clinical trial scheme of the medical device shall specify the number of clinical trial cases, duration and clinical evaluation criteria according to the characteristics of the specific tested product, so that the test results have statistical significance.
- What should the clinical trail scheme include?
- Title of the clinical trial.
- Purpose, background and content of the clinical trial.
- Clinical evaluation criteria.
- Risk and benefit analysis of the clinical trial.
- Name, position, professional title and department of clinical trial personnel.
- Overall design, including a probability analysis of success or failure.
- Duration of the clinical trial and reason for such determination.
- Number of clinical trial cases of each disease entity and reason for such determination.
- Selected object scope, object quantity and reason for such selection, and the group setting to be compared when necessary.
- Therapeutic products should have clear indication(s) or scope of application.
- Clinical performance evaluation methods and statistical treatment methods.
- Prediction of side effects and measures to be taken.
- The subject’s “informed consent”.
- Responsibilities of the parties.