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61 Wilder Street, Opera Library 3rd Floor Lowell, MA 01854 Tel: 978.934.2797 Fax: 978.934.2065 Email: honors UML.edu www.uml.edu/honorsI Understand Note: Every honors' student must have a signed copy
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China's medical device regulations refer to the laws and guidelines set by the Chinese government to regulate the manufacturing, distribution, and use of medical devices in the country.
Manufacturers, importers, and distributors of medical devices are required to file China's medical device regulations.
To fill out China's medical device regulations, companies need to provide detailed information about their medical devices, manufacturing processes, quality control measures, and distribution channels.
The purpose of China's medical device regulations is to ensure the safety, efficacy, and quality of medical devices available in the Chinese market.
The information that must be reported on China's medical device regulations includes details about the device's design, materials, intended use, manufacturing location, and clinical data.
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