Category: Standards

Clinical and Performance Evaluation under EU-MDR – New CE Market Rules

August 5, 2021
Standards

Clinical evaluation of medical devices is a systematic and planned process that contributes to the continuous generation, collection, analysis and evaluation of clinical data on a particular device....

clinical and performance evaluation, clinical trial Requirements, EU MDR, FDA clinical trial Regulations, Medical Device clinical Investigation Requirements, new ce market rules

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...

Clinical practice, Good clinical practice guidelines India, ICH E6 Guidelines for Good Clinical Practice, ICH GCP principles, ICH good clinical practice principles

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

June 24, 2021
Standards

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

Adverse Reaction Reporting Guide for New Zealand

June 2, 2021
Standards

New Zealand tends to have a high rate when it comes to adverse reaction reporting. The Centre for Adverse Reactions Monitoring (CARM), Dunedin acts as the national repository. This entire data helps...

adverse drug reactions, centre for Adverse Reactions monitoring, guide for adverse reaction reports, pharmacists.

FDA Warning Letter Jan-Apr 2021 Recap Summary

May 6, 2021
Standards

Warning DescriptionProducts & SummaryFDA has seen manufacturer’s Website and their claims on products, as per that they fit in the definition of the devices and has not taken approval or clearance...

The US FDA handed out 15 warning letters in March to manufacturers of various products that were unapproved to mitigate or prevent COVID-19.

EU Regulations: Things Still to be known

February 22, 2021
Standards

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...