As the special subject of the applicant for registration of medical device, the research and development institutions have insufficient conditions and abilities to become medical device registrants, and there are certain difficulties in the actual registration application process, such as not clearing the certification path for the research and development institutions to hold the certificate. In view of the existing problems, by comparing the path of medicine research and development institutions to become medical device registrants and combining with the actual medical device industry to give relevant suggestions, including improving quality management over the whole life cycle of medical devices, quality and safety responsibility ability of research and development institutions, establishing the registration and certification path of research and development institutions, supporting laws and regulations, etc., so as to ensure that the research and development institutions become medical device registrants successfully.
Research ; Certification

This paper introduced the overview of the "eight trends" of Chinese medicinal materials(CMM) industry in 2021, analyzed the problems of CMM production, and put forward development suggestions. Specifically, "eight trends" could be summarized as follows.(1) The growing area of CMM tended to be stable, and some provinces began to release the local catalog of Dao-di herbs.(2) The protection process of new varieties accelerated, and a number of excellent varieties were bred.(3) The theory of ecological cultivation was further enriched, and the demonstration effect of ecological cultivation technology was prominent.(4) Some CMM realized complete mechanization and formed typical model cases.(5) The number of cultivation bases using the traceability platform increased, and provincial internet trading platforms were set up.(6) The construction of CMM industrial clusters accelerated, and the number of provincial-level regional brands increased rapidly.(7) Many new agricultural business entities were founded nationwide, and a variety of methods were used to drive the intensified development of CMM.(8) A number of local TCM laws were promulgated, and the management regulation of food and medicine homology substances catalogs was issued. On this basis, four suggestions for CMM production were proposed.(1) It is suggested to speed up the formulation of the national catalog of Dao-di herbs and carry out the certification of Dao-di herbs production bases.(2) Ecological planting of forest and grassland medicine should be further strengthened in terms of technical research and promotion based on the principle of ecological priority.(3) The basic work of disaster prevention should be paid more attention and technical measures for disaster mitigation should be developed.(4) The planted area of commonly used CMM should be incorporated into the national regular statistical system.
Agriculture ; Certification ; Commerce ; Industry ; China

BACKGROUND: Internal medicine (IM) doctors in Japan play the role of primary care physicians; however, the shortage of rural physicians continues. This study aims to elucidate the association of age, sex, board certification, type of work, and main clinical work with the retention or migration of IM doctors to rural areas. METHODS: This retrospective cohort study included 82,363 IM doctors in 2010, extracted from the national census data of medical doctors. The explanatory variables were age, sex, type of work, primary clinical work, and changes in board certification status. The outcome was retention or migration to rural areas. The first tertile of population density (PD) of municipalities defined as rural area. After stratifying the baseline ruralities as rural or non-rural areas, the odds ratios (ORs) of the explanatory variables were calculated using generalized estimation equations. The analyses were also performed after age stratification (<39, 40-59, ≥60 years old). RESULTS: Among the rural areas, women had a significantly higher OR for retention, but obtaining board certification of IM subspecialties had a significantly lower OR. Among the non-rural areas, physicians who answered that their main work was IM without specific subspecialty and general had a significantly higher OR, but obtaining and maintaining board certification for IM subspecialties had a significantly lower OR for migration to rural areas. After age stratification, the higher OR of women for rural retention was significant only among those aged 40-59 years. Those aged under 40 and 40-59 years in the non-rural areas, who answered that their main work was IM without specific subspecialty had a significantly higher OR for migration to rural areas, and those aged 40-59 years in the rural areas who answered the same had a higher OR for rural retention. CONCLUSIONS Obtaining and maintaining board certification of IM subspecialties are possible inhibiting factors for rural work, and IM doctors whose main work involves subspecialties tend to work in non-rural areas. Once rural work begins, more middle-aged female IM doctors continued rural work compared to male doctors.
Middle Aged ; Humans ; Male ; Female ; Retrospective Studies ; East Asian People ; Certification ; Physicians ; Internal Medicine

BACKGROUND: One effective way to improve return-to-work (RTW) performance may be to convince the employer that the worker has the necessary skills. The aim of this paper is to investigate the effect of having a professional certification among workers injured in occupational injuries on their return to work. METHODS: The Panel Study of Workers' Compensation Insurance (PSWCI) targets workers who completed medical care in 2012 after an occupational injury. The study population (n = 2000) was stratified by gender, age, region, disability grade, and rehabilitation service use. A total of 1458 workers were finally selected for this study. The effect of having a certification on RTW status was calculated with an odds ratio and 95% confidence intervals using binomial and multinomial logistic regression analyses. In the binomial logistic regression analysis, the RTW group was made up as a combination of the return to original work and the reemployment groups. RESULTS: The ORs of RTW among those with a certification compared to those without certification were 1.38 (1.16-1.65) in Model 1, 1.25 (1.05-1.50) in Model 2, and 1.22 (1.01-1.47) in Model 3. Among female workers with a certification, the OR of RTW was 4.60 (2.68-7.91), that of return to original work was 3.21 (1.74-5.91), and that of reemployment was 5.85 (3.34-10.27). Among daily workers with a certification, the OR of RTW was 1.32 (1.03-1.69) and that of reemployment was 1.37 (1.07-1.76). CONCLUSION In conclusion, injured workers with a certification generally had a higher RTW rate. In particular, the RTW rate was higher among female workers and daily workers with a certification than among those without.
Adult ; Aged ; Aged, 80 and over ; Certification/statistics & numerical data* ; Humans ; Middle Aged ; Occupational Injuries/statistics & numerical data* ; Republic of Korea ; Return to Work/statistics & numerical data* ; Vulnerable Populations/statistics & numerical data* ; Workplace/statistics & numerical data* ; Young Adult

According to the teaching philosophy of the outcome-based education, this study elaborates the development of a practical innovation course for biological engineering major after five runs of teaching practice and continuous improvement. It mainly includes the methods for selection of teaching subjects, implementation of teaching process, process assessment, evaluation and improvement. Based on the performance and achievements of three grades of students majored in bioengineering, we found that the logic and methods of the practical innovation course could greatly stimulate the motivation of students for learning, as well as their scores. Therefore, the logic and methods described in this study may serve as a reference for the reforms of practical training courses of engineering major under the background of Engineering Education Certification.
Bioengineering ; Certification ; Curriculum ; Humans ; Learning ; Students

certification as a general surgeon trained 2 other gynecologic oncologists in bowel resection and upper abdominal surgery for 4 years. After the initial learning period, the trained gynecologic oncologists performed surgeries without the certificated general surgeon in 195 patients with FIGO III/IV. The surgical outcomes and perioperative complications during the 2 periods were evaluated.RESULTS: The rates of achieving no gross disease after cytoreductive surgery were 80.0% in the initial learning period and 83.6% in the post-learning period (p=0.560). The incidence of anastomotic leakage after rectosigmoid resection, symptomatic pleural effusion or pneumothorax after right diaphragm resection, and pancreatic fistula after splenectomy with distal pancreatectomy in the 2 periods were 2 of 34 (6.0%), 1 of 33 (3.0%), and 3 of 15 (20.0%) patients in the initial learning period, and 12 of 147 (8.2%), 1 of 118 (0.8%), and 11 of 84 (13.1%) patients in the post-learning period, respectively. There were no significant differences between the 2 groups (p=0.270, p=0.440, p=0.520, respectively).CONCLUSION: Bowel resection and upper abdominal surgery can be performed safely by gynecologic oncologists.]]>
Anastomotic Leak ; Certification ; Cytoreduction Surgical Procedures ; Diaphragm ; Gynecology ; Humans ; Incidence ; Learning ; Obstetrics ; Ovarian Neoplasms ; Pancreatectomy ; Pancreatic Fistula ; Pleural Effusion ; Pneumothorax ; Postoperative Complications ; Splenectomy

The standard sample of natural products is an essential standard reference to determine the quality of the product in the quality control of natural products. To develop a certified reference material(CRM) of swertioside according to the Work Guideline for Reference Materials(3): Reference Material-General Principles and Statistical Method for Certification(GB/T 15000.3-2008), swertioside was purified from whole plant of Swertia mussotii by extraction, isolation and Prep-HPLC to obtain certified reference material of swertioside. The structure of swertioside was identified by IR, UV, high-resolution MS, NMR. Thin layer chromatography, optical rotation, elemental analysis and melting point was carried out for the identification. The purity of the prepared sample was tested from different chromatographic elution conditions, thin layer chromatography and HPLC-MS. Swertioside was divided into 140 bottles, with 10 mg per bottle after homogeneity test, stability test and quantitative analysis. This CRM is 7-O-[α-L-rhamnopyranosyl-(1→2)-β-D-xylopyranosyl]; the homogeneity of the 95% confidence interval was good; the certified purity value was 98.66%, with a relative expanded uncertainty of 0.38%; the storage period was 36 months at 0-8 ℃. Therefore, the CRM of sakuranetin reached the technical requirements of CRM, and was accepted by SAC. Swertioside is successfully developed and can be used for determining content, evaluating test methods, detecting relevant products and controlling quality.
Certification ; Chromatography, High Pressure Liquid ; Mass Spectrometry ; Phytochemicals/standards* ; Reference Standards ; Swertia/chemistry*

The main chemical constituents of naphthopyrone reference extract( NRE) with definite content and relatively fixed chemical composition were analyzed and determined. Ultra-high performance liquid chromatography-LTQ-Orbitrap XL mass spectrometry and high performance liquid chromatography were used to systematically study NRE from the aspects of main chemical components and determination. The results showed that the chemical composition of naphthopyrone reference extract of Cassiae Semen was relatively fixed,and seven naphthalopyranones were identified. Cassiaside B_2,cassiaside C_2,rubrofusarin-6-O-β-D-gentiobioside and cassiaside C were the main chemical constituents of NRE,of which the determination and uncertainty results were( 11. 40+ 0. 26) %,( 11. 68+0. 24) %,( 16. 60+0. 22) %,( 28. 8+0. 48) %,respectively. This study contributed to the accurate evaluation of NRE and the foundation for the application of NRE in the quality control of Cassiae Semen,and provided a new idea for the replacement of single chemical reference substance by the reference extract of traditional Chinese medicine.
Cassia ; chemistry ; Certification ; Chromatography, High Pressure Liquid ; Drugs, Chinese Herbal ; standards ; Mass Spectrometry ; Plant Extracts ; standards ; Quality Control ; Seeds ; chemistry

Certification ; Laboratories ; United States

Certification ; Laboratories