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General Specifications Change Notification (GSC)WR #GSC Noneffective DateWR21283AIDC Application Standard Master DID for registration of certain type of devices within EUDAMEDAug 2024Associated Work
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Gather all necessary product information, including UDI and DI details.
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Who needs master udi-di gscnratification25042024 with?
01
Manufacturers of medical devices and products that require UDI compliance.
02
Regulatory affairs professionals responsible for product registration.
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Quality assurance teams involved in product documentation and certification.
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Supply chain managers overseeing inventory tracking and compliance.
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What is master udi-di gscnratification25042024 with?
The master udi-di gscnratification25042024 is a regulatory form used for documenting and certifying unique device identifiers (UDI) for medical devices as mandated by regulatory authorities.
Who is required to file master udi-di gscnratification25042024 with?
Manufacturers of medical devices that are required to have a UDI must file the master udi-di gscnratification25042024 with the appropriate regulatory agency.
How to fill out master udi-di gscnratification25042024 with?
To fill out the master udi-di gscnratification25042024, manufacturers must provide product details, including the UDI, device description, and compliance information as specified in the instructions provided by the regulatory agency.
What is the purpose of master udi-di gscnratification25042024 with?
The purpose of the master udi-di gscnratification25042024 is to ensure that medical devices are correctly identified, traceable and adhere to safety regulations.
What information must be reported on master udi-di gscnratification25042024 with?
The information that must be reported includes the product's unique device identifier (UDI), device name, model, manufacturer details, and any relevant compliance regulations.
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