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

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

In recent years, emerging technology medical devices have developed rapidly. How to more scientifically and more efficiently regulate these novel medical devices so as to improve access to advanced medical technology while ensuring safety and effectiveness is a new challenge faced by regulatory authorities, and is also the core topic of regulatory science. New tools, new standards and new methods are important means to achieve regulatory science. "Medical Device Development Tool" proposed by the U.S. FDA is a novel medical device regulatory science tool, which can help medical device developers to predict and evaluate product performance more efficiently. It is also helpful for regulatory authorities to make regulatory decisions more efficiently. This study introduces the concept, qualification process, role of MDDT in medical device regulation and MDDT examples, and makes some discussion on the device evaluation from the perspective of reliability and validity. MDDT can facilitate the developing of novel medical device.
United States ; Medical Device Legislation ; Reproducibility of Results ; United States Food and Drug Administration ; Technology ; Device Approval

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

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*

This paper studies the necessity of the current legislation on the supervision of medical devices in China from the perspectives of strengthening administration according to law, protecting public health, perfecting the legal system of medicine and promoting the development of the medical device industry. This study analyzes and summarizes the legislative experiences and forms in the field of medical device regulation in the United States, the European Union, Japan and other countries and regions, at present, the conditions of carrying out the legislation of medical device supervision in China are quite mature, and some policy suggestions are put forward for the enactment of the law of medical device management in China.
Equipment and Supplies ; European Union ; Feasibility Studies ; Industry ; Medical Device Legislation ; United States ; United States Food and Drug Administration

BACKGROUND: Health policies in the Philippines have evolved in response to increasing health demands of older adults. However, there is a lack of research on equity among the ageing population in low-middle income countries. The objective of this study was to identify the trends in National Health Insurance Program (NHIP) coverage and healthcare utilization among older adults in the Philippines for the period from 2003 to 2017, during which NHIP expansion policies were implemented, focusing on reductions in socio-economic inequalities. METHODS: A literature search of policies for older adults and an analysis of four Philippine National Demographic and Health Surveys (2003, 2008, 2013, and 2017) with data from 25,217 older adults who were 60 years or older were performed. The major outcome variables were NHIP coverage, self-reported illness, outpatient healthcare utilization, and inpatient healthcare utilization. Inequalities in NHIP coverage and healthcare utilization according to wealth were evaluated by calculating the concentration index for individual years, followed by a regression-based decomposition analysis. RESULTS: NHIP coverage among older adults increased from 9.4 (2003) to 87.6% (2017). Although inequalities according to wealth quintile were observed in all four surveys (all P < 0.001), the concentration index declined from 0.3000 (2003) to 0.0247 (2017), showing reduced inequalities in NHIP coverage over time as observed for self-reported illness and healthcare utilization. NHIP coverage expansion for older adults in 2014 enabled equal opportunity for access to healthcare. CONCLUSION The passage of mandatory NHIP coverage for older Filipino adults in 2014 was followed by a reduction in inequality in NHIP coverage and healthcare utilization according to wealth.
Aged ; Aged, 80 and over ; Female ; Healthcare Disparities ; trends ; Humans ; Insurance Coverage ; trends ; Male ; Middle Aged ; National Health Programs ; legislation & jurisprudence ; statistics & numerical data ; Philippines ; Socioeconomic Factors

In this paper, we reviewed the history of the registration and classification changes of traditional Chinese medicines(TCM) since the establishment of China's drug regulatory agency, and put forward relevant suggestions. Although China's drug regulatory agency has gone through 22 years, the whole regulatory system was gradually built on the basis of the generic pharmaceutical industry at that time and through continuous exploration and summary of simply experience from foreign regulatory agencies. To a certain extent, the supervision of TCM drugs was also affected by some immature supervision ideas during this period. Based on the newly issued Drug Administration Law and Provisions for Drug Registration, the author puts forward some personal thoughts on the classifications of TCM drug registration. It is hoped that experts in the industry and regulatory agencies will work together to explore and improve the relevant system of TCM registration administration.
China ; Drugs, Chinese Herbal ; Legislation, Drug ; Medicine, Chinese Traditional ; Pharmaceutical Preparations

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

Autopsy ; Biomedical Research ; ethics ; legislation & jurisprudence ; Brain ; pathology ; Humans ; Tissue Banks ; ethics ; legislation & jurisprudence