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Medical Devices New Application Review Formulas tick all that apply:NEW Application Brand Label (OIL)Transferase Track (expedited)ModularDirective(s) that apply : Directive×NSA File Number MDD (93/42/EEC) 252./AID
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Medical devices new application is a submission to gain approval from regulatory authorities for the introduction of a new medical device to the market.
Manufacturers, distributors, or importers of medical devices are required to file a new application.
The application can be filled out online or through a physical form provided by the regulatory authority, with detailed information about the medical device.
The purpose of the application is to ensure that the new medical device meets the necessary safety and efficacy standards before being introduced to the market.
The application must include information about the design, intended use, components, manufacturing process, and clinical data of the medical device.
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