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

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

OBJECTIVETo explore the access to tobacco and exam the predictors of successful tobacco purchase attempts among Chinese minors.

METHODSA simulative trial of purchasing cigarettes was participated by 201 sixth grade students to assess the prevalence of illegal cigarette sales to minors in Guangzhou. Methods of Chi-square and unconditional logistic regression were used to identify the significant predictors,with the result of tobacco purchase as the dependent variable and the characteristics of stores, retailers and minors as the independent variables.

RESULTSA total of 165 students succeeded in purchasing cigarettes but 36 failed, and the percentage of successful purchase attempts was 82. 1% . Data from univariate analysis indicated that 9 factors were significantly associated with students' success in purchasing cigarettes. They were age and height of the purchasers, types of stores, seller's gender and age, posting cigarette advertisements,showing warning signs of 'no cigarette selling to minors' ,asking buyer's age,and asking whom you buy the cigarettes for. The results of multivariable analysis showed that only three variables entering the final logistic regression: the age of students, the type of stores, and showing warning signs of 'no cigarette selling to minors'.

CONCLUSIONChinese minors have easy access to purchasing cigarettes, especially in groceries and small markets. Selling cigarettes by sellers to minors should be monitored and managed in the future.

Adolescent ; Child ; China ; Commerce ; legislation & jurisprudence ; statistics & numerical data ; Female ; Humans ; Male ; Minors ; statistics & numerical data ; Smoking ; epidemiology ; legislation & jurisprudence ; Students ; statistics & numerical data

BACKGROUND: Acetylcholinesterase inhibitor insecticides (AChEIIs) were used extensively in the agrarian region of Anuradhapura for the past few decades. As a result, the region faced a heightened risk of toxicity. Carbaryl, carbofuran, chlorpyrifos, dimethoate, and fenthion were the five hazardous AChEIIs banned from Anuradhapura in 2014. Assessment of post-ban trends in acute poisoning will reveal the impact of the ban. Data on availability and sales of remaining AChEIIs will guide towards preventive measures against related toxicities. METHODS: Cross-sectional surveys were conducted at Anuradhapura district of Sri Lanka. Details related to acute AChEII poisoning were sorted from the Teaching Hospital Anuradhapura. Main insecticide vendors in Anuradhapura were surveyed to find information on availability and sales of AChEIIs. Chi-square for goodness of fit was performed for trends in acute poisoning and sales. RESULTS: Hospital admissions related to acute AChEII poisoning have declined from 554 in 2013 to 272 in 2017. Deaths related to acute AChEII poisoning have declined from 27 in 2013 to 13 in 2017. Sales of all five banned AChEIIs had reduced by 100%. Sales of the remaining AChEIIs were declining, except for acephate, phenthoate, and profenofos. However, one of the top selling, most frequently abused carbosulfan, had the highest risk of toxicity. Chi-square for goodness of fit showed a significance (P < 0.001) between the trends of hospital admissions for acute AChEII poisoning and the sales related to AChEIIs. CONCLUSIONS Hospital admissions related to acute poisoning was declining along with the overall sales of remaining AChEIIs, during the post-AChEII ban period. Nevertheless, future vigilance is needed on the remaining AChEIIs to predict and prevent related toxicities.
Agriculture ; legislation & jurisprudence ; Cholinesterase Inhibitors ; classification ; poisoning ; supply & distribution ; Commerce ; statistics & numerical data ; trends ; Cross-Sectional Studies ; Developing Countries ; Female ; Government Regulation ; Health Policy ; legislation & jurisprudence ; Hospitalization ; statistics & numerical data ; trends ; Humans ; Incidence ; Insecticides ; classification ; poisoning ; supply & distribution ; Male ; Poisoning ; epidemiology ; mortality ; prevention & control ; Risk Factors ; Sri Lanka ; epidemiology

With the development of biotechnology, forensic DNA identification technology in protection of wild animals has been used more and more widely. This review introduces the global status of wildlife crime and the relevant protection to wildlife, outlines the practical applications of forensic DNA identification technology with regard to species identification, determination of geographic origin, individual identification and paternity identification. It focus on the techniques commonly used in DNA typing and their merits and demerits, as well as the problems and prospects of forensic DNA technology for wildlife conservation.
Animals ; Animals, Wild/genetics* ; Commerce/legislation & jurisprudence* ; Conservation of Natural Resources ; Crime/legislation & jurisprudence* ; DNA/genetics* ; DNA Fingerprinting/methods* ; DNA, Mitochondrial/genetics* ; Forensic Genetics ; Molecular Sequence Data ; Polymerase Chain Reaction/methods* ; Polymorphism, Restriction Fragment Length ; Sequence Analysis, DNA ; Sequence Analysis, Protein ; Species Specificity