Passive medical devices
2021-03-25
海外认证
Overseas Certification
All categories
经典案例
Classic Case
FDA registration & CRCS service flow chart
- Categories:美国FDA
- Time of issue:2021-03-25 14:55:25
- Views:0
Description:
Information
The medical device FDA certification is the customary name of the medical device industry for the registration process before the medical device enters the US market. Strictly speaking, it should be called FDA registration or FDA pre-market registration of medical devices. The FDA's management of medical devices is carried out by the Center for Devices and Radiological Health (CDRH), which is responsible for overseeing the design, production, packaging, and marketing of medical devices.
The FDA's review refers to the QSR820 quality system specification, which describes the requirements of the current Good Manufacturing Practice (CGMP). This specification specifies the methods, facilities and controls used in the design, manufacturing, packaging, labeling, storage, installation and service of all finished medical devices. These requirements are to ensure the safety and effectiveness of finished medical devices and to comply with the U.S. Food, Drug and Cosmetic Act. This specification sets out the basic requirements applicable to manufacturers of finished medical devices.
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info@crcs.com.cn
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Company Introduction
The company specializes in medical device registration, in vitro diagnostic reagents registration, cosmetics agent service company, committed to the NMPA, CE regulation research and product registration and certification service has been more than 17 years.
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Beijing Medical & Care Co. Ltd.