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ICH: Guideline on Testing for Carcinogenicity of Pharmaceuticals, an Addendum

August 30, 2021
Biopharma

Over the course of drug development, it is important for sponsors to develop a scientifically robust strategy for carcinogenicity assessment that considers key biologic, pharmacologic, and toxicologic...

Addendum, Guideline on Testing for Carcinogenicity, Pharmaceuticals, Testing for Carcinogenicity of Pharmaceuticals

Regulatory Changes for Software Based Medical Devices in Australia

August 20, 2021
Medical Device

The Therapeutic Goods Administration (TGA) regulates software-based medical devices; including software that functions as a medical device in its own right, and software that controls or interacts...

Medical device labelling requirements, regulatory guidance, Software as a Medical Device, Software Based Medical Devices in Australia, Therapeutic Goods Administration (TGA)

Medical Devices – Regulatory Updates – August Volume 2

August 19, 2021
Medical Device

EUROPE 1.Guidance for industry on MHRA’s expectations for return to UK on-site inspections In line with a reduction in restrictions, the inspectorate plans to resume an on-site UK risk-based...

EU Medical Device Labelling, Europe medical devices regulatory updates, India dgft regulatory updates, Medical device labelling requirements, Medical Devices Regulatory Updates, Regulatory Updates August Volume 2, us medical devices regulatory updates

SaMD Regulatory Landscape in the US and Europe

August 13, 2021
Standards

Software as a medical device (SaMD) has emerged as a class of devices for collecting, processing and analyzing healthcare data to manage disease. Powered by analytics, SaMD accelerates the diagnosis...

compliant with good clinical practice, Digital Health, how the regulatory landscape is changing, Navigating a complex regulatory environment, Software as a Medical Device, the regulatory landscape for SaMD

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

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...