RESOLUTION - RDC Nº 305, OF SEPTEMBER 24, 2019
It sets out requirements for the manufacture, marketing, import and exposure to the use of personalized medical devices.
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It sets out requirements for the manufacture, marketing, import and exposure to the use of personalized medical devices.
To have access to this whole Resolution, click on HERE .
It provides for the identification of medical devices regularized in Anvisa, through the Unique Identification of Medical Devices (UDI) system.
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It provides for the requirements for grouping materials for use in health for registration and notification purposes in the National Health Surveillance Agency and adopts traceability labels for implantable products.
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It provides for the obligation to describe the composition in Portuguese on the labelling of personal care products, cosmetics and perfumes.
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It provides for the regularization of disposable personal hygiene products intended for body cleanliness, which include brushes and rods for oral hygiene, dental floss and tape, disposable sanitary napkins, menstrual cups and flexible rods.
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