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The implementation of the new "Regulations" breaks the development deadlock, the medical device clin

Issuing time:2021-06-28 13:48

The newly revised "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations"), which came into effect on June 1, encourages innovation in the medical device industry from the policy level, strengthens life-cycle quality management, and escorts the high-quality development of the industry. Under the new regulatory environment, my country's medical device clinical trial industry is facing many new changes.



  The industry calls for a perfect system



   my country's medical device market has great potential. With the support of national policies, the industry is booming. But at the same time, we must also see that my country's medical device industry started late, and the clinical trial industry is advancing through exploration and development, and there are still pain points.



   The "Medical Device Clinical Trial Institutions Conditions and Filing Management Measures" promulgated in 2017, set off a wave of domestic medical device clinical trial institutions filing, and the problem of insufficient number of clinical trial institutions has been effectively resolved. However, there are still problems such as insufficient clinical trial experience of researchers, uneven clinical trial management capabilities of medical institutions, and uneven distribution of clinical trial institutions.



   In addition, my country's medical device innovation and R&D is still in its infancy, and domestic products on the market are mainly low-end products. Low-end product development costs are low, easy to imitate, and the market is saturated. Repeated clinical trials of the same type have caused unnecessary consumption of clinical resources. This has also led to fierce competition in the homogenization of contract research organizations (CRO) to a certain extent, passively fighting a "price war" in the field of low-end products, which hindered the development of the industry.



   At present, the state has issued a number of policies to promote the survival of the fittest by medical device companies, and more innovative medical devices have entered the track. In order to adapt to the national strategic industry planning, it is necessary to improve relevant regulations and industry standards for medical device clinical trials as soon as possible.



  New regulations bring new changes in clinical trials



  Clinical trials are an important part of the medical device innovation ecology and require a sound regulatory and standard system for guidance. The new "Regulations" are of great significance to the revision of relevant content of medical device clinical trials.



   Redefine the development of clinical trials



   Article 25 of the new "Regulations" clarifies the path for clinical evaluation of medical devices, including clinical trials and clinical evaluations of the same variety. However, in the 2017 version of the “Regulations,” only the first category of medical device product filing materials mentioned in Article 10 “Clinical evaluation data does not include clinical trial reports, which can be data obtained through literature and clinical use of similar products to prove that the medical device is safe, Valid materials"; Article 11 refers to "Clinical evaluation materials shall include clinical trial reports" in the second and third category medical device product registration application materials.



   At the same time, the new "Regulations" also accurately define the medical devices that "should carry out clinical trials". Article 17 of the 2017 “Regulations” states that “the first category of medical device products does not need to be registered, and clinical trials are not required. When applying for the second and third category of medical device product registration, clinical trials should be conducted” (satisfaction can be exempted Except in the case of trials), Article 25 of the new "Regulations" stipulates that "in the clinical evaluation of medical devices, the existing clinical literature and clinical data are not sufficient to confirm the product safety and effective medical devices, and clinical trials should be carried out."



   In addition, the new "Regulations" proposed for the first time the "exemption from clinical evaluation". Article 24: “Medical device product registration and filing shall be subject to clinical evaluation; however, if one of the following conditions is met, clinical evaluation may be exempted: (1) The working mechanism is clear, the design is finalized, the production process is mature, and it has been marketed. The same type of medical device has been used for many years without serious adverse event records, and does not change its routine use; (2) Other medical devices that can prove the safety and effectiveness of the medical device through non-clinical evaluation." The new "Regulations" deletes the provisions of Article 17 of the 2017 version of the "Regulations" that exempt medical devices from clinical trials. In the future, documents may be issued to guide the revision of the catalog of medical devices that are exempt from clinical evaluation.



It can be seen that the 2017 "Regulations" is mainly based on the risk classification of medical devices to determine whether clinical trials are required, while the new "Regulations" have more flexible judgment principles, clearer and more reasonable classification methods, and detailed evaluation of the clinical evaluation pathways of specific products. It is necessary to carry out clinical trials to avoid “one size fits all”, consistent with the clinical trial decision-making thinking of internationally coordinated documents, and reasonably reduce the burden on the industry.



  Improve the enthusiasm and ability of medical institutions to carry out clinical trials of medical devices



On the basis of Article 18 of the 2017 "Regulations" that regulates the quality management of medical device clinical trials, clinical trial filing and clinical trial institution filing, Article 26 of the new "Regulations" further adds "The state supports medical institutions to carry out clinical trials, Incorporate clinical trial conditions and capability evaluation into the level review of medical institutions, encourage medical institutions to carry out clinical trials of innovative medical devices", further increase the enthusiasm of medical institutions to carry out clinical trials of medical devices, and play a positive role in the construction of medical device clinical trial quality management capabilities of medical institutions effect.



   High-risk clinical trial approval implements "implicit permission"



On the basis of Article 19 of the 2017 edition of the Regulations, which stipulates the approval department for clinical trials of Class III medical devices and the establishment of the high-risk Class III medical device catalog, Article 27 of the new “Regulations” adds Class III Medical device clinical trial review and analysis direction, approval period and "implicit permission" related content. The new regulations stipulate that a decision shall be made and the clinical trial sponsor shall be notified within 60 working days from the date of acceptance of the application; if the notification is not given within the time limit, it shall be deemed as consent. Further improve the transparency and efficiency of the approval of clinical trials of third-class medical devices.



   Emphasis on protecting the rights and interests of subjects



Article 28 of the new "Regulations" is newly added "To carry out clinical trials of medical devices, ethical reviews shall be carried out in accordance with the regulations, and subjects shall be informed of the purpose, use and possible risks of the trial, and the subjects’ written knowledge shall be obtained. Consent; if the subject is a person without or with limited capacity for civil conduct, the written informed consent of his guardian shall be obtained in accordance with the law. To carry out clinical trials, the subjects shall not be charged for clinical trial-related expenses in any form". This clause emphasizes the protection of the rights and interests of subjects in terms of ethical review, risk knowledge, and trial costs.



  Support for extended clinical trials of medical devices



Article 29 of the new "Regulations" added "For medical devices that are undergoing clinical trials for serious life-threatening diseases without effective treatments, medical observations may benefit patients, and they shall be subject to ethical review and informed consent. Later, it can be used free of charge for other patients with the same condition in institutions that conduct clinical trials of medical devices, and its safety data can be used for medical device registration applications." Supporting the extended clinical trials of medical devices from the institutional level is conducive to better handling the relationship between the safety and effectiveness of medical devices, controllable quality, life care, and access to treatment.



   Opportunities and challenges coexist



   For the medical device clinical trial industry, the new "Regulations" are rich in new content and have major changes, which will have a profound impact on registrants, medical institutions and CROs.



  For the registrant



  The new "Regulations" allow companies to take different clinical evaluation paths at different levels according to the actual product conditions. As a result, the scope of medical devices for clinical trials may be reduced, which will help companies to decompress and relax and save clinical resources.



   In addition, after the implementation of the new "Regulations", the cost of clinical registration of low-end products will be reduced. Registrants who use these products as their core products may experience the pain of product market saturation. Actively transforming, innovating, R&D, and optimizing resource allocation to enhance corporate competitiveness are effective paths for such registrants to seek living space.



  For medical institutions



  Medical institutions are the most sensitive to the clinical needs of patients, and excellent clinical researchers and teams can well promote the transformation of scientific research results and promote the deep integration of industry, university and research. At the same time, good clinical trial process management is also conducive to improving the quality of clinical trials and increasing the acceptance and recognition of my country's independent innovative medical devices at home and abroad.



The new "Regulations" supports and encourages medical institutions to carry out clinical trials of medical devices, and incorporates the evaluation of conditions and capabilities for clinical trials into the level review of medical institutions, aiming to mobilize the enthusiasm of medical institutions to carry out clinical trials and strengthen the cultivation of clinical research talents by medical institutions , The importance of the construction of professional teams and the quality management of clinical trials, and effectively solve the problem of the shortage of high-quality clinical trial resources.



  For contract research organizations



Under the new "Regulations", the number of medical device clinical trials may be greatly reduced. Clinical trials will mainly focus on innovative medical devices, third-class high-risk medical devices, drug-device combination products, tissue engineering, artificial organs, degradable materials, etc. . The program design, sample size estimation, and specific implementation of clinical trials of medical devices in these key areas are qualitatively different from most past clinical trials of medical devices. They are difficult, costly, and have a long cycle, and there are certain risks. Therefore, the industry has put forward higher professional and international service requirements for CRO companies.



   In addition, the new "Regulations" also implements the medical device registrant system, and the CRO may be deeply involved in the full life cycle of the product with the registrant. The CRO business will expand from the original single clinical evaluation intermediate link to upstream market research, product development, quality management system construction, product traceability, and downstream recall, adverse event monitoring and post-marketing real-world research.



  The new "Regulations" took medical device clinical trials as one of the policy reforms, breaking the deadlock in the development of the industry and injecting new vitality into the development of the industry. Under the new regulatory environment, the opportunities and challenges of all parties involved in clinical trials of medical devices coexist, which will usher in an inflection point in the great waves.


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