The MvPI reportable adverse events include but are not limited to: A malfunction or deterioration in the characteristics or performance of the medical device An incorrect or out-of-specification test result The discovery of a design flaw during design review An inaccuracy in labeling, instructions for use and/or promotional materials.Inaccuracies include …
Regulation of Medical devices in India The Central Drugs Standard Control Organization (CDSCO) under Directorate General of Health Services in Ministry of Health and Family Welfare (MoHFW), Government of India (GoI) is the National Regulatory Authority (NRA) responsible for approval of manufacturing, import, conduct of clinical trials, laying down standards, …
As per recent medical device safety information from MHRA, the Philips HeartStart MRx monitor/defibrillator therapy selector switch may fail, resulting in abnormal device behaviours including: the device may not perform the selected function the therapy knob may not change to the energy setting selected the device may deliver a shock …
• A Clinical Evaluation Report (CER) for Medical Device is a document that contains the conclusions of the clinical evaluation performed on the medical device based on all relevant clinical data available.• before obtaining CE marking in the European Union, the medical device manufacturers must prove that their devices meet …
A new guidance finalised by the US Food and Drug Administration (FDA) outlines the framework for electronic submissions for medical devices. The guidance clarifies submissions which can be made electronically: Premarket notifications (501k) Evaluation of automatic class III designation request (De Novos) submissions (513(f)(2)) Premarket approval applications (PMAs) including transitional …
Once the company became aware of reportable incident the clock starts. If a death or serious injury has occurred it has to be reported between 2 and 10 calendar days (refer below table). Less serious events/incidents can be reported in 15 to 30 calendar days. If there is an incident …
The FDA monitors reports of adverse events and other problems with medical devices and alerts health professionals and the public when needed to ensure proper use of devices and the health and safety of patients. The Center for Devices and Radiological Health (CDRH) is an FDA component and looks after …
