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This enactment requires the Registrar of Medical Devices, designated by the Minister of Health, to establish and maintain a Medical Devices Registry. The Registry will contain, with their consent, the names and addresses of persons who use implantable medical devices or prescribed home-use medical devices, a description of the medical devices and other information. Personal information in the Registry may not be disclosed for any purpose without the person’s written and informed consent.
The enactment requires the manufacturers, importers and distributors of these medical devices to notify the Registrar if they become aware that a medical device may pose a risk to the health or safety of the user. The Registrar is required to notify registered users if a medical device may pose a risk to their health or safety.
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