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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...

ICH E6 Good Clinical Practice Principles

June 30, 2021
Standards

The ICH E6 Good Clinical Practice (GCP) Guideline is widely used by clinical trial researchers beyond the membership and regional representation of ICH itself and has a significant impact on trial...

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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...

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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

Clinical Trial Management Guidelines under Covid-19 – Europe

June 9, 2021
Standards

Good Clinical Practice (GCP) is referred to an internationally acclaimed ethical and scientific quality standard for designing, recording and reporting trials involving participation of human subjects....

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