急求英文高手帮忙翻译 万分感谢!!!
求英文高手帮忙翻译万分感谢!Dentalmaterialsanddevicesaresubjecttolegalreg¬ulationsinmostcountri...
求英文高手帮忙翻译 万分感谢!
Dental materials and devices are subject to legal reg¬ulations in most countries. In this chapter such legal regulations in different parts of the world are reviewed. 1he Global Harmonization Task Force (GHTF), which is an international group of medical device regulators and industry representatives from the United States, Canada, Europe, Japan, and Australia, is working to¬ward a global regulatory system for medical devices by developing broad principles for the regulation of medical devices that can be implemented by individ¬ual jurisdictions. All these regulations address safety (including biocompatibility) and effectiveness of the materials and devices. Dentists should know about the regulations and their responsibilities required by the regulations (for example, adverse effect reporting). Manufacturers should be knowledgeable about regu¬lations in countries in which their products are to be marketed. These include meeting the requirements for medical device directives, product requirements, and record keeping and reporting, as well as postmarket surveillance. There are also regulations concerning waste disposal, environmental protection, and oc¬cupational safety. These subjects will be reviewed in Chaps. 12 and 13. Only the name of original versions of regulations and standards will be cited in this re¬view, but the actual effective version is always meant. 展开
Dental materials and devices are subject to legal reg¬ulations in most countries. In this chapter such legal regulations in different parts of the world are reviewed. 1he Global Harmonization Task Force (GHTF), which is an international group of medical device regulators and industry representatives from the United States, Canada, Europe, Japan, and Australia, is working to¬ward a global regulatory system for medical devices by developing broad principles for the regulation of medical devices that can be implemented by individ¬ual jurisdictions. All these regulations address safety (including biocompatibility) and effectiveness of the materials and devices. Dentists should know about the regulations and their responsibilities required by the regulations (for example, adverse effect reporting). Manufacturers should be knowledgeable about regu¬lations in countries in which their products are to be marketed. These include meeting the requirements for medical device directives, product requirements, and record keeping and reporting, as well as postmarket surveillance. There are also regulations concerning waste disposal, environmental protection, and oc¬cupational safety. These subjects will be reviewed in Chaps. 12 and 13. Only the name of original versions of regulations and standards will be cited in this re¬view, but the actual effective version is always meant. 展开
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