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Get Priceplace it into more than one class, classification and conformity assessment should be based on the highest class indicated. 4. Determine if the device is subject to any special rules. 7. aClassification Rules for Medical Devices. The actual classification of each device depends on the precise claims made by the manufacturer and on its intended use.
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Get PriceUSA and Japan are reviewing STED submissions to assess compliance with local requirements. 8. Manufacturers and distributors of medical devices intended for sale in the USA are required to register annually with the FDA. This process is known as establishment registration.
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