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...
COVID-19
The LÆGEMIDDELSTYRELSEN, the Danish Medicines Agency, published guidance describing the extraordinary measures for clinical trials in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19). COVID-related Regulatory Background The Danish Medicines...
COVID-19
The Food and Drug Administration (FDA) issued updated guidance dedicated to tests intended to be used in the context of the outbreak of COVID-19. Due to the importance of the highlighted issues, the guidance is subject to immediate implementation without public...
FDA
The Food and Drug Administration (FDA) issued guidance dedicated to unique device identification (UDI). The policy covers issues related to compliance dates for Class I and unclassified medical devices, and also certain devices requiring direct marking. The present...
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...
