Blog Category: Medical Device

Authorization of Medical Devices based on the ASEAN Harmonized Technical Requirements

September 8, 2021
Medical Device

The fast evolution of medical technology and the essential role of medical devices in the health care delivery system have highlighted the importance of ensuring the safety and effectiveness of these...

asean harmonized technical, authorization of medical devices, harmonization technical, Medical Devices

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

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...

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...