The result under the AIA would be an EU technical documentation certificate (article 44 AIA) which seems to be complementary to an MDR / IVDR certificate and, according to the MDR / IVDR, might be accounted for in a single declaration of conformity for the AI system under both regulations (...
Results:(1) Graduates know more than undergraduates and the clinical students know more than the non-clinical students in the knowledge of medical laws & regulations. 结果:(1)在对医疗法规相关知识的知晓率上,研究生高于本科生,临床相关专业高于非临床相关专业;(2)医学生对医疗法规相关知识及医患关系的...
The British Chamber has partnered with LexisNexis to bring you key policy updates from the Chinese government each week, in the sectors that matter to British businesses in China. From awareness of regulations and policies that...
Dental professionals who practice in the UK must follow the General Dental Council (GDC) Standards, one of which is to "find out about laws and regulations that affect your work and follow them". Dental professionals manufacture custom-made devices (CMDs) and the legislation that go...
Breach of regulations and laws regulating a given concurrent activity is considered unfair under Law no. 3/1991 on Unfair Competition, as is to prevail in each market with a competitive advantage that is acquired because of breach of law. ...
the viability of a lawsuit for damages caused by the use of a drug will depend on the defendant’s intentionality, and the degree of liability will be directly linked to the degree of compliance with the regulations of use, as a factor of attenuation, exoneration or aggravation of liability....
(iii) the IVD reagent has obtained medical device registration, and (iv) the testing item has fallen into theList of Clinical Testing in Medical Institutions(《医疗机构临床检验项目目录》). Also, due to the insufficiency of guidance...
AnalysisonCurrentLawsandRegulationsofMedicalDeviceClinical 系统标签: 器械医疗临床试验trialmedical ChineseJournalofMedicalInstrumentation 监管与测试 61 2014年38卷第1期 收稿日期:2012-08-06 基金项目:科技部“重大新药创制”科技重大专项(20112X09302-003-02); 江苏省科技创新平台提升项目(B2011017) 作者简介:王悦,...
我国医疗器械风险管理法规现状与发展方向的分析-analysis on the current situation and development direction of chinas medical device risk management laws and regulations.docx,PAGE PAGE 2 第一部分 前言 我国医疗器械风险管理法规现状与发展方向的研究 的要求产生
Mindray, a maker of hospital equipment, has always actively pursued free trade, strictly complied with laws, regulations, and regulatory requirements of different countries, and participated in market competition in accordance with the law, Securities Times reported today, citing ...