Regulations and Standards
Dental materials and devices are subject to legal regulations in most countries. These regulations address safety (including biocompatibility) and the effectiveness of the materials and devices. Dentists should know of the regulations and the responsibili
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3.1
Introduction
Dental materials and devices are subject to legal regulations in most countries. In this chapter such legal regulations in different parts of the world are reviewed. The 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 toward a global regulatory system for medical devices by developing broad principles for the regulation of medical devices that can be implemented by individual jurisdictions. All these regulations address safety (including biocompatibility) and effectiveness of the
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3.3.2 3.3.3 3.3.4 3.4 3.5 3.5.1 3.5.2 3.5.3 3.6 3.7 3.7.1 3.7.2 3.7.3 3.8.
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . Legal Regulations in the European Union . . Medical Device Directive . . . . . . . . . . . . . . . . European Chemical Legislation (REACH) . Legal Regulations in the United States . . . . . Food, Drug, and Cosmetic Act and Medical Device Amendments . . . . . . . . Classification of Devices . . . . . . . . . . . . . . . . Premarket Notification and FDA Review . . Records and Reports on Devices . . . . . . . . . Legal Regulations in Australia . . . . . . . . . . . . Legal Regulations in Japan . . . . . . . . . . . . . . . Classification and Marketing Authorization Marketing and Manufacturing Licenses . . . Marketing Authorization . . . . . . . . . . . . . . . . Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Harmonized Standards . . . . . . . . . . . . . . . . . OECD Guidelines . . . . . . . . . . . . . . . . . . . . . . Relevant Standards . . . . . . . . . . . . . . . . . . . . . Surveillance and Reporting Systems . . . . . . . Conclusions for the Dental Practitioner . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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3.1 3.2. 3.2.1 3.2.2 3.3 3.3.1
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 regulations 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 occupational 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 review, but the actual effective version is always meant.
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Contents
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3.2
Legal Regulations in the European Union
In the European Union (EU), a number of regulations appl
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