The traditional regulation mode on medical devices has invalid and negative effect problems. In order to more effectively ensure safety and efficacy of medical devices, promote healthy industrial development, this paper puts forward the innovative concept of smart regulation on the basis of problem orientation. Compared with traditional regulatory mode, smart regulation focus on effectiveness, and pays attention to relationship between effective regulation with self-discipline and industrial development, has characteristics of improving pertinence, effectiveness, accuracy, speed and efficiency of regulation. This paper further elaborates implementation approaches and attentions of smart regulation, by the ways of strengthening credit management, intelligent regulation, professional regulation, promoting self-discipline and encouraging innovation.
Humans ; Medical Device Legislation

Type inspection is a necessary precondition of technical evaluation of medical device. The implementation of The Provisions for Administration of Self-Test for Medical Device Registration facilitates the registration pathway for applicants. How to improve the effectiveness of registration self-test has drawn attention from many stakeholders. In this study, we analyzed and discussed the factors affecting the validity of registration self-test from technical evaluation perspective, and proposed suggestions for improvement accordingly. The aim of this article is to boost the reliability and effectiveness of registration self-test and offer a reference for applicants to carry out registration self-test.
Medical Device Legislation

No abstract available.
Accreditation/*legislation & jurisprudence ; Education, Medical/*legislation & jurisprudence ; Humans ; *Legislation, Medical ; Physicians/*legislation & jurisprudence ; Republic of Korea

OBJECTIVE: To interpret the key contents of the guidance of Personalized Medical Device Regulatory Pathways issued by the IMDRF, and provide reference for the improvement of China's medical device regulatory system. METHODS: The regulatory requirements of personalized medical devices and point-of-care manufacture of medical device were described respectively, and the feasibility of implementing the regulation of point-of-care manufacture of medical device in China was analyzed. RESULTS: The different regulatory pathways of medical devices produced at point-of-care are feasible and have different regulatory risks. CONCLUSIONS In combination with the recommendations provided by the IMDRF guidance and the clinical and regulatory realities in China, we should accelerate the improvement of the regulations and supporting documents for point-of-care manufacture of medical device in China.
Commerce ; Medical Device Legislation ; China

Dentists ; legislation & jurisprudence ; Humans ; Legislation as Topic ; Malpractice ; legislation & jurisprudence ; Medical Errors ; legislation & jurisprudence

Dentists ; legislation & jurisprudence ; Dissent and Disputes ; legislation & jurisprudence ; Humans ; Malpractice ; legislation & jurisprudence ; Medical Records ; Pulpitis ; diagnosis ; therapy

OBJECTIVE: To found the quantifiable index of "The severe degree of negligence" in describing the general severity degree of medical malpractice or medical dispute. METHODS: "The severe degree of negligence" can be calculated by the way of multiplying the coefficient of medical malpractice's grade by the coefficient of responsibility degree. RESULTS: There are 15 grades of "The severe degree of negligence" through calculation, from the severest degree of 1 to the lightest degree of 20. CONCLUSION "The severe degree of negligence" can give an order of severe degree to different grade and different responsibility of medical malpractice. According to this order, the operation of medical malpractice and medical dispute settle will be easier and more rationality.
Expert Testimony/legislation & jurisprudence* ; Forensic Medicine ; Humans ; Liability, Legal ; Malpractice/legislation & jurisprudence* ; Medical Errors/legislation & jurisprudence*

The license management of medical devices is an important part of production supervision, but there are some contradictions and confusion in the relevant legislation. The right way of resolve the plight is to distinguish correctly license application on the medical devices production for the first time, license change and license continuity, and then make the appropriate regulatory requirements.
China ; Durable Medical Equipment ; Licensure ; legislation & jurisprudence

Through the analysis of laws and policies related to registration self-inspection, visiting and researching enterprises, holding symposiums, and issuing nationwide questionnaires, the risks in the registration self-inspection process were summarized, analyzed, and evaluated. From the aspects of regulatory departments and manufacturing enterprises, we suggest to improve China's medical device registration regulations system and reduce the risks of all parties in the registration self-inspection work.
Risk Management ; Commerce ; Medical Device Legislation

On October 21, 2021, the National Medical Products Administration issued and implemented the Self-examination Management Regulations for Medical Device Registration. The regulations clarify the specific requirements of the registration applicants in the process of self-examination, and put forward detailed requirements from the aspects of self-examination ability, self-examination report, declaration materials and responsibility requirements, so as to ensure the orderly development of the self-examination of medical device registration. Based on the actual verification work of in vitro diagnostic reagent, this study briefly discussed the understanding of the relevant contents of the regulations, aiming to provide some reference for enterprises and related supervision departments that have the requirement of registered self-examination.
Medical Device Legislation ; Reagent Kits, Diagnostic/standards*