Blog Category: Medical Device

TGA’s Reclassification of Medical devices around the corner. Ready?

June 24, 2021
Medical Device

The New Reclassification system for medical devices is round the corner to its effective date (25 Nov 2021) of implementation. The clock is ticking on Australian reclassification submissions. The Reclassification...

Australian TGA medical device registration consulting, TGA medical device, TGA reclassification of medical devices, Therapeutic goods administration

Clinical Outcome Assessments (COAs) in Medical Device Decision Making

June 23, 2021
Medical Device

A clinical outcome assessment (COA) describes or reflects how a person feels, functions, or survives and can be reported by a health care provider or a non-clinical observer (such as a parent), through...

clinical outcomes assessment in devices, Clinician reported outcomes (ClinROs), Observer reported outcomes (ObsROs), Patient-reported outcomes (PROs), Performance outcomes (PerfOs)

Serotonergic Anti-depressants for Depression in Pregnant Women

June 16, 2021
Medical Device

New Zealand’s Medicines and Medical Devices Safety Authority (MEDSAFE) has published few takeaways pertaining to the new minimal risk of postpartum haemorrhage with the consumption of certain anti-depressants...

benefits of treating depression for mother, minimal risk of postpartum hemorrhage, new minimal risk of postpartum, Serotonergic Anti-depressants

Unique Device Identification System

May 13, 2021
Medical Device

The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use. When fully implemented,...

FDA requires medical device labelers, GUDID, Medical Devices, Medical Devices Labeling, UDI, Unique Device Identification System

EU Regulations: Things Still to be known

February 22, 2021
Medical Device

Medical Device Regulations (EU) 2017/745 is an advancement that would help EU in coping with medical science changes. Manufacturers will regard the new regulations as a benchmark globally as it would...

Labeling and IFU Compliance Soon to Follow EU MDR Transition

February 22, 2021
OTC

Multiple manufacturers are seeing postponement of the EU MDR as a boon. This one-year delay has helped them in organizing the labeling and instructions for use associated with their medical devices....

EU MDR Transition, General Labeling Requirements under EU, Medical Device Labeling, Medical Device Labeling Regulations, medical device labeling requirements, medical device labels