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The medical devices regulatory system is based on regulations issued by the State Council, NMPA orders and NMPA documents that provide detailed rules for medical device registration and licensing practice. [10] Medical device type testing must be based upon the Chinese National Standard (Chinese: Guobiao, GB) or at least on an Industry Standard ...
The 2002 Medical Device User Fee and Modernization Act (MDUFA) first granted FDA the authority to collect user fees from industry to help the FDA improve efficiency, quality, and predictability of medical device submission reviews; the medical device user fee program has been reauthorized several times with the most recent in 2022.
An import license is a document issued by a national government authorizing the importation of certain goods into its territory. Import licenses are considered to be non-tariff barriers to trade when used as a way to discriminate against another country's goods in order to protect a domestic industry from foreign competition.
The main types of licenses are general license that permits unrestricted importation or exportation of goods included in the lists for a certain period of time; and one-time license for a certain product importer (exporter) to import (or export). One-time license indicates a quantity of goods, its cost, its country of origin (or destination ...
Medical device is to be for use in supporting or sustaining human life, of substantial importance in preventing impairment of human health, or presents a potential unreasonable risk of illness or injury, is to be subject, premarket approval to provide reasonable assurance of its safety and effectiveness.
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Medical Device Regulation Act of 1976 in the United States ... Text is available under the Creative Commons Attribution-ShareAlike 4.0 License; ...
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