FDA
The Food and Drug Administration (FDA or the Agency), the US authority responsible for medical devices regulation, issued an enforcement policy dedicated to the telethermographic systems in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19) caused...
Uncategorized
The Malaysian Medical Device Authority (MDA) issued official guidance dedicated to notification for orphaned medical devices. Scope of the Guidance The document was published by the MDA in order to assist all parties involved in operations with medical devices to...
Asia
Bangladesh has recently published updated requirements for the manufacturing, importation, distribution and sales of medical devices on their domestic market. The Scope of the Guidelines At the moment, medical device circulation guidelines are regulated under the...
Uncategorized
What Is It? ISO 13485 is a quality management system that is used internationally. It controls safety in work environments, risk management, and design, and creates requirements for inspections, documents, procedures, and verification of safety and effectiveness of...
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