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Global Medical Device Nomenclature (GMD) GMD A Requirement for AUDI Mark Warmth CEO, GMD AgencyWhat is the GMD? Global Medical Device Nomenclature (GMD) The international standard (ISO 15225) for
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Fill out the applicant's personal details accurately, including name, contact information, and any other requested information.
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Provide detailed information about the medical device, including its purpose, specifications, and intended use.
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If applicable, include any applicable certifications or regulatory approvals the medical device has obtained.
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Clearly state the country or countries where the medical device will be marketed or distributed.
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Who needs global medical device:
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Manufacturers or companies producing medical devices that have the intention to market or distribute their products globally.
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Researchers or innovators developing new medical devices intended for international use.
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Distributors or importers planning to import medical devices from other countries for sale within their own market.
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What is global medical device?
Global medical device refers to medical devices that are distributed internationally and comply with regulations across multiple countries.
Who is required to file global medical device?
Manufacturers, importers, distributors, and authorized representatives of medical devices are required to file global medical device.
How to fill out global medical device?
Global medical device can be filled out by providing detailed information about the device, its intended use, manufacturing process, and regulatory compliance.
What is the purpose of global medical device?
The purpose of global medical device is to ensure the safety and efficacy of medical devices distributed worldwide.
What information must be reported on global medical device?
Information such as device specifications, labeling, clinical data, risk assessment, and compliance with regulatory requirements must be reported on global medical device.
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