To implement the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Pharmaceuticals and Medical Devices" issued by the General Office of the CPC Central Committee and the General Office of the State Council, address clinical treatment needs for serious life-threatening diseases, and accelerate the review and approval process for relevant medical devices, the National Medical Products Administration has developed the Guiding Principles for Conditional Approval of Medical Devices for Market Launch (see attachment). These principles are hereby released.

　　Hereby notified.

　　Attachment: Guiding Principles for Conditional Approval of Medical Devices for Market Launch

　　National Medical Products Administration

　　December 17, 2019

　　Attachment

　　Guiding Principles for Conditional Approval of Medical Devices for Market Launch

　　To implement the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Pharmaceuticals and Medical Devices" issued by the General Office of the CPC Central Committee and the General Office of the State Council, address clinical treatment needs for serious life-threatening diseases, and accelerate the review and approval of relevant medical devices, these Guiding Principles are formulated in accordance with the "Regulations on the Supervision and Administration of Medical Devices," taking into account China's requirements for medical device registration management and practical experience in review work.

　　I. Scope

　　These guidelines apply to the registration of medical devices seeking conditional approval for market launch.

　　II. Basic Principles

　　For medical devices intended to treat serious, life-threatening diseases for which no effective treatment options currently exist, full consideration should be given to the balance between the data expected to be collected after the device is marketed and the data already collected prior to market approval, and a comprehensive risk-benefit assessment of the product should be conducted. The data collected prior to market approval should demonstrate that the medical device has shown efficacy and can reasonably predict or determine its clinical value; under such circumstances, conditional approval for the device’s marketing may be granted.

　　Conditional approval for the marketing of medical devices should help increase patients with serious, life-threatening diseases for which there are currently no effective treatment options to gain timely access to new devices.

　　From the justification for conditional approval of market launch, the establishment of accompanying conditions, to the collection of post-market data, conditional approval of medical devices offers flexibility in terms of clinical trial requirements. However, this flexibility must not compromise the comprehensive evaluation of the safety and effectiveness of medical devices.

　　III. Basic Requirements

　　The applicant shall thoroughly assess the benefit-risk ratio and residual risks associated with the conditional approval of the product for marketing, and the risk assessment results shall demonstrate that the benefits outweigh the risks.

　　During the product registration application process and after conditional approval for marketing, the applicant and the registrant shall continue to conduct clinical trials and complete other required studies and tasks in accordance with the established clinical trial protocol.

　　In addition to the documentation required by these guidelines, the registration submission materials shall also comply with other requirements for medical device registration applications.

　　IV. Communication and Exchange

　　Before and after a medical device is launched on the market, applicants and registrants may submit requests for communication and exchange to the technical review agency regarding major technical issues, significant safety concerns, clinical trial protocols, and the fulfillment of conditions attached to the registration certificate.

　　V. Preclinical Study Requirements

　　(1) Pre-clinical study data shall reasonably verify the safety and efficacy of the product being submitted for approval, and the applicant shall conduct a thorough assessment of any potential risks.

　　(2) Pre-clinical study data shall include, but are not limited to, the applicant’s scientific research findings, such as laboratory data, animal studies, cell assays, simulation studies, and/or summaries of relevant literature, as well as performance studies, biocompatibility evaluation studies, stability studies, and software-related study data.

　　VI. Clinical Trial Requirements Prior to Market Launch

　　(1) Clinical trial data shall include at least the following: the clinical trial protocol, the opinion of the ethics committee, a description of circumstances requiring mandatory treatment, the informed consent form (text), and the clinical trial report. Any special circumstances shall be specifically explained.

　　(2) The design of clinical trial protocols and statistical analysis methods shall be scientifically sound and reasonable, and shall comply with the requirements of China’s regulations, rules, and guiding principles pertaining to medical device registration.

　　(3) Applicants may incorporate surrogate endpoints into the study design when drafting the clinical trial protocol, and use these surrogate endpoints to evaluate the product’s safety and efficacy. It is important to ensure the scientific rigor of the evaluation, including appropriate statistical considerations.

　　(4) A surrogate endpoint in clinical trials refers to an indicator that can demonstrate efficacy and reasonably assess the clinical value of a product; however, it is not the primary endpoint of the clinical trial and does not directly measure long-term clinical benefits.

　　(5) The determination of surrogate endpoints for clinical trials shall be based on the plausibility of the relationship between the disease, long-term endpoints, and the expected effect, as well as on the scientific evidence supporting such a relationship. Applicants shall provide evidence demonstrating the relevance and evaluability of the surrogate endpoint in relation to the primary endpoint of the clinical trial.

　　(6) Clinical trial data shall demonstrate that the product being submitted has shown efficacy and allows for a reasonable assessment or judgment of its clinical value.

　　(7) The applicant may communicate with the technical review agency to determine the evaluation indicators for products seeking conditional approval for market launch, as well as the requirements for clinical trial data, criteria for reasonably assessing or judging their clinical benefits, the design of clinical trials, and other relevant content.

　　(8) The applicant shall thoroughly assess the risks potentially associated with the submitted clinical trial data for the product being declared. This includes the severity, type, number, and incidence rate of adverse events, the duration of harm caused to subjects by adverse events, as well as the type, number, and incidence rate of surgery-related complications.

　　(9) Clinical trial data shall comply with the relevant requirements for medical device registration, be scientific, authentic, accurate, complete, and traceable, and shall not involve selective screening. The applicant shall ensure that the rights and interests of subjects in clinical trials are protected and that any risks to other individuals are effectively controlled.

　　7. Conditional Requirements

　　(1) The registrant of a medical device shall, within the prescribed time limit, fulfill the requirements stipulated in the remarks column of the medical device registration certificate regarding post-market approval conditions.

　　The validity period of a medical device registration certificate issued under conditional approval is consistent with the deadline for fulfilling the accompanying conditions specified on the certificate.

　　(2) The conditions attached may include the following:

　　1. Continue to complete the pre-market clinical trials;

　　2. New post-marketing clinical studies;

　　3. Clinical use information for the product after it has been launched;

　　4. Other requirements, including additional tasks and obligations that must be completed within a specified timeframe after the product is launched—for example, the scope of medical institutions authorized to use the medical device, competency requirements for users, the need for prior approval by the ethics committee before use, and the time limits for relevant studies.

　　(3) The registrant shall indicate the product’s risks on the product label and in the instructions.

　　VIII. Post-Market Surveillance

　　(1) The registrant shall strengthen the monitoring of adverse events for medical devices approved for market launch under conditional approval and shall comply with the relevant provisions of the “Administrative Measures for Monitoring and Re-evaluation of Adverse Events of Medical Devices.”

　　(2) The registrant shall collect data related to benefits and risks throughout the entire lifecycle of the medical device and continuously monitor and evaluate the benefits and risks of the submitted product.

　　(3) When any of the following circumstances occur, the registrant shall promptly and proactively apply for cancellation of the medical device registration certificate:

　　1. The evidence obtained by the registrant in accordance with the conditions specified in the registration certificate indicates that the risks outweigh the benefits.

　　2. Re-evaluation fails to demonstrate the product’s safety and effectiveness.