Guidance Document - Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs) - Canada.ca 该文件针对SOR-98-282中每个分类规则提供了更多详细的补充描述以及给出了具体的产品案例,可以帮助我们进一步论证分类判别的准确性。 例如:还是这款验光仪的产品,我们在指南中并没...
II、III或IV类医疗器械制造商如希望申请获得医疗器械许可证,则必须证明其产品符合加拿大医疗器械管理规定的要求(CMDR SOR/98-282)。因此,他们需要向加拿大负责医疗器械许可的监管部门——加拿大卫生部,提交其医疗器械的技术文档,包括安全性和功效相关的证据。技术文档包括符合国际标准的证据...
4)Fees for Health Canada -202206075)SOR-98-282-Medical Device Regulations-20220725 加拿大医疗器械分类 Health Canada医疗器械分类情况如下: 一、 加拿大医疗器械的分类 根据医疗器械的预期用途,Health Canada将医疗器械和IVD都分为四类:I, II, III, IV类,其中I类的风险最低,IV类的风险最高。 二、医疗器械(...
Season, latitude, and the time of day It has been established that the ozone layer can absorb UVB radiation above 290 nm which is responsible for generating previtamin D3. Zenith angle, defined as the angle of the sunlight reaching the Earth's surface, decides the thickness of ozone layer ...
Weaver JA, Maddox JF, Cao YZ, Mullarky IK, Sordillo LM: Increased 15-HPETE production decreases prostacyclin synthase activity during oxidant stress in aortic endothelial cells. Free Radic Biol Med. 2001, 30: 299-308. 10.1016/S0891-5849(00)00466-4 Article CAS PubMed Google Scholar Scrimshaw...
Table2a shows that UK-based studies made up a relatively high proportion of published DCEs (17%, 50 studies), as did studies from the US (17%, 50 studies), Australia (10%, 30 studies), the Netherlands (15%, 44 studies), Germany (9%, 28 studies) and Canada (8%, 25 studies). ...
and latitude. Thus those factors have great effects on vitamin D production [28,29]. For example, residents of Boston (42°N), Edmonton, Canada (52°N) and Bergen, Norway (61°N) can not produce sufficient quantities of vitamin D in their skin for 4, 5, and 6 months, respectively ...
4)Fees for Health Canada -202206075)SOR-98-282-Medical Device Regulations-20220725 加拿大医疗器械分类 Health Canada医疗器械分类情况如下: 一、 加拿大医疗器械的分类 根据医疗器械的预期用途,Health Canada将医疗器械和IVD都分为四类:I, II, III, IV类,其中I类的风险最低,IV类的风险最高。