Asia
The Medical Device Authority (MDA), a branch of the Ministry of Health Malaysia responsible for medical device regulation, issued guidance documents dedicated to handling complaints, and mandatory problem reporting. Regulatory Background The Malaysian regulating...
FDA
The Food and Drug Administration (FDA or the Agency), the US authority responsible for medical devices regulation, issued the enforcement policy for remote digital pathology devices in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by...
FDA
The Food and Drug Administration (FDA) issued guidance dedicated to the digital health devices used to treat psychiatric disorders in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus” and...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission composed of representatives of all the EU Member States, issued guidance dedicated to the Unique Device Identification (UDI) system implemented by the Medical Device Regulation...
North America
The US Food and Drug Administration (FDA), the authority responsible for medical devices regulation, issued guidance dedicated to 510(k) premarket notification submissions for Electrosurgical devices for general surgery. The scope of the document covers devices based...
Gartner® Market Guide for Life Science Regulatory Information Management Solutions
Download NowGartner® Market Guide for Regulatory Intelligence Solutions
Download Now
