Category: Medical Device

Medical Devices-Regulatory Updates-Asia Round Up-Jul 2021

August 4, 2021
Medical Device

Malaysia (MDA) 1. Malaysia’s MDA updates guidelines for testing medical face masks Malaysia’s Medical Device Authority (MDA) has updated its guidelines for the testing of medical face masks in...

Medical Devices USA/Europe Regulatory Updates round up, Jul 2021

August 4, 2021
Medical Device

EUROPE 1. First references of harmonised European standards in support of Regulation (EU) 2017/745 published in the OJEU: Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 In accordance...

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