Europe
The Bosnia and Herzegovina Agency for Medicines and Medical Devices, the country’s regulating authority in the sphere of healthcare products, has published a user guide dedicated to the national information system for medical devices. General Information About...
Canada
Health Canada, the Canadian regulating authority in the sphere of healthcare products, has issued guidance on summary reports and issue-related analyses for medical devices. Regulatory Background The regulatory requirements for importation, distribution and marketing...
North America
The medical device regulating authority in the United States, the FDA, issued special warning on cybersecurity threats related to cardiac implantable devices (ICDs). According to the document placed on the official website, the FDA aims to alert both companies and...
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