The National Medical Products Administration (NMPA) has released guiding principles for the conditional approval of medical devices.

On December 20, a notice was released on the website of the National Medical Products Administration (NMPA) to implement the Opinions of the General Offices of the Central Committee of the Communist Party of China and the State Council on deepening the reform of the review and approval system and encouraging innovation in drugs and medical devices, address the clinical treatment needs of life-threatening diseases, and accelerate the review and approval of relevant medical devices. The NMPA has formulated and released the Guiding Principles for Conditional Approval of Medical Devices.

Attachment: Guiding Principles for Conditional Approval of Medical Devices 

To implement the Opinions of the General Offices of the Central Committee of the Communist Party of China and the State Council on deepening the reform of the review and approval system and encouraging innovation in drugs and medical devices, address the clinical treatment needs of 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, combining relevant requirements for medical device registration management in China and the practices of review work.

1. Scope

These guiding principles apply to the registration of medical devices intended for conditional approval.

2. Basic Principles

For medical devices for the treatment of life-threatening diseases for which there are no effective treatment methods, the balance between the expected data collected after the medical device is marketed and the data collected before marketing should be fully considered, and the risk-benefit of the product should be comprehensively assessed. The data collected before marketing should be able to demonstrate that the medical device has shown efficacy and can reasonably predict or judge its clinical value, and the medical device can be conditionally approved for marketing. Conditional approval of medical devices for marketing should help increase the opportunity for patients with life-threatening diseases for which there are no effective treatment methods to use new devices in a timely manner. From the argument for conditional approval, the setting of conditions, to the collection of post-market data, conditional approval has flexibility in the requirements for medical device clinical trials, but it must not reduce the requirements for the comprehensive evaluation of the safety and effectiveness of medical devices.

3. Basic Requirements

Applicants should fully assess the benefit-risk ratio and residual risks of the product for conditional approval, and the risk assessment results should show that the benefits outweigh the risks. During the registration application process and after conditional approval, the applicant and registrant should continue to conduct clinical trials and complete other research work and requirements according to the established clinical trial plan. In addition to meeting the requirements of these guiding principles, the registration application materials should also meet other requirements for medical device registration applications.

4. Communication and Exchange

Before and after the medical device is marketed, applicants and registrants may submit applications for communication and exchange to the technical review agency regarding major technical issues, major safety issues, clinical trial plans, and the completion of conditions attached to the registration certificate.

5. Preclinical Study Requirements

(1) Pre-clinical trial data should reasonably verify the safety and effectiveness of the declared product, and the applicant should fully assess the potential risks.

(2) Pre-clinical trial data includes, but is not limited to, the applicant's scientific research results, such as laboratory data, animal experiments, cell experiments, simulation experiments, etc., and/or a summary of relevant literature, as well as performance research, biocompatibility evaluation research, stability research, and software research data.

6. Pre-market Clinical Trial Requirements

(1) Clinical trial data shall include at least: clinical trial plan, ethics committee opinion, statement of necessity for treatment, informed consent form (text), clinical trial report, etc.; specific explanations should be provided for any special circumstances.

(2) The design of the clinical trial plan and the statistical analysis methods should be scientific and reasonable, and should meet the requirements of relevant laws, regulations, and guiding principles for medical device registration in China.

(3) Applicants can incorporate surrogate endpoints into the research design when designing clinical trial plans to assess product safety and effectiveness by analyzing surrogate endpoints, paying attention to the scientific nature of the assessment, such as statistical considerations.

(4) Surrogate endpoints in clinical trials are indicators that can show efficacy and reasonably assess the clinical value of a product, but they are not the primary endpoints of clinical trials, and do not directly measure long-term clinical benefits.

(5) The determination of surrogate endpoints in clinical trials needs to be based on the rationality of the relationship between disease, long-term endpoints, and expected effects, as well as scientific evidence supporting this relationship. Applicants should provide evidence to prove the correlation and evaluability of surrogate endpoints and primary endpoints in clinical trials.

(6) Clinical trial data should demonstrate that the declared product has shown efficacy and can reasonably assess or judge its clinical value.

(7) Applicants can communicate with the technical review agency and determine the evaluation indicators for products applying for conditional approval, as well as the requirements for clinical trial data, the standard for reasonably assessing or judging clinical benefits, clinical trial design, and other content.

(8) Applicants should fully assess the potential risks of the declared product shown by the submitted clinical trial data, such as the severity, type, number and incidence of adverse events, the duration of harm caused to subjects by adverse events, the type, number and incidence of surgery-related complications, etc.

(9) Clinical trial data should meet the relevant requirements for medical device registration, be scientific, true, accurate, complete, traceable, and not screened. Applicants should ensure that the rights and interests of subjects in clinical trials are protected, and that the risks that other personnel may suffer are controlled.

7. Conditional Requirements

(1) The medical device registrant shall complete the requirements of the conditions attached to the marketing approval stated in the remarks column of the medical device registration certificate within the stipulated time limit. The validity period of the registration certificate for conditionally approved medical devices is consistent with the completion time limit of the attached conditions stated in the registration certificate.

(2) Attached conditions may include the following:

1.  Continuing to complete pre-market clinical trials;

2.  New post-market clinical research;

3.  Clinical use information of the product after marketing;

4. Other requirements, including other work and requirements that should be completed within the specified time limit after the product is launched, such as the scope of medical institutions using the medical device, the ability requirements of users, the need for ethical committee approval before use, and the time limit for relevant research.

(3) The registrant shall indicate the risks of the product on the product label and instructions for use.

VIII. Post-market Surveillance

(1) The registrant shall strengthen the monitoring of adverse events of medical devices approved for conditional marketing, and comply with the relevant provisions of the "Measures for Monitoring and Re-evaluation of Medical Device Adverse Events".

(2) The registrant shall collect data related to benefits and risks throughout the life cycle of the medical device, and continuously monitor and evaluate the benefits and risks of the declared product.

(3) The registrant shall promptly and actively apply for cancellation of the medical device registration certificate in the following circumstances:

1.  The evidence obtained by the registrant according to the conditions specified in the registration certificate indicates that the risks outweigh the benefits;

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