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Thailand’s Medical Device Control Division has published guidelines on medical device product recalls. The document is intended to assist medical device manufacturers and other parties involved in operations with medical devices in ensuring compliance with the...
FDA
The Food and Drug Administration (FDA) has published guidance dedicated to requesting FDA feedback on combination products. The document is intended to improve the clarity and transparency of the existing regulatory framework for combination products. Due to its legal...
Europe
The Slovenian Agency for Medicinal Products and Medical Devices (JAZMP) issued guidance dedicated to the regulatory requirements of protective elements on colored drawings on medical device packages. In particular, the document describes specific aspects to be...
FDA
The Food and Drug Administration (FDA or the Agency), the US authority responsible for medical device regulation, announced amendments to the MDDT framework. Medical Device Development Tools (MDDT) The Agency published a notice dedicated to certain amendments made to...
EU MDR/IVDR
The European Commission (EC), the medical device regulating authority of the European Union, issued a new regulation regarding standardization aspects in the context of Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation...
Europe
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance on 3D printing of medical devices and components in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19). Scope of the MHRA Guidance The present guidance published by...
