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摘 要 :
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This document was developed by the International Organization for Standardization (ISO) to assist regulators and market surveillance authorities.It is especially intended for developing regions, to design market surveillance systems that conform to modern good practice criteria and that make the best use of the “CASCO Toolbox” of International Standards and other deliverables that have been developed to support good regulatory practice.This document recognizes that there are vast differences between developing countries, and while they qualify as developing on economic data, they also utilize standards, regulatory and conformity assessment legal frameworks, working institutions and competent staff. Likewise, some countries classed as developed on economic data may also benefit from the guidance given in this publication.INTRODUCTIONTHE NEED FOR MARKET SURVEILLANCEGOOD PRACTICE CRITERIARESOURCES, COSTS AND BENEFITSPRIORITIZINGNATIONAL, REGIONAL AND GLOBAL ISSUESSECTORIAL EXAMPLES OF GOOD PRACTICEELECTRONIC AND ELECTRICAL PRODUCTS MEDICAL DEVICES
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