Japanese regulatory ministry publishes guidance on biocompatibility testing to updated standard

Japan – Japan PMDA updates MDSAP policies ahead of 2022 implementation deadlines

A new notification from Japanese medical device market regulators have clarified procedures whereby manufacturers may use Medical Device Single Audit Program (MDSAP) reports to...
TGA Creates Advertising Guidance for Providers of Cell and Tissue Products

Australia – Australian regulators plan up-classification of medical devices targeting circulatory, nervous systems

The Australian Therapeutic Goods Administration (TGA) has issued new guidance on plans to reclassify medical devices involved in circulatory and nervous systems from Class...
TGA Updates Guidance on the Testing of Biological Medicines

Australia – Australia Regulatory Roundup: medical device clinical evidence, reclassification, post-market monitoring

The Australian Therapeutic Goods Administration (TGA) has rolled out several updates in recent weeks affecting regulations of medical devices and in vitro diagnostic (IVD)...

China – IVD classification rules, medical device self-testing requirements

The China National Medical Products Administration (NMPA) has published new classification rules for in-vitro diagnostic (IVD) medical devices, as well as requirements for manufacturers...

Australia – Reclassification of medical devices that are substances introduced into the human body...

The purpose of this guidance is to assist sponsors of medical devices that are substances for introduction into the body with meeting their obligations...

Australia – Software for use with COVID-19 rapid antigen self-tests

This guidance includes information about the Therapeutic Goods Administration's (TGA) requirements for software and apps designed for use with COVID-19 rapid antigen self-tests...
CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

India – Indian regulators propose easing ISO 13485-related requirements for medical device registrants

India’s Ministry of Health and Family Welfare has proposed easing medical device registration requirements related to proof of ISO 13485 quality management system (QMS)...
Japanese regulatory ministry publishes guidance on biocompatibility testing to updated standard

Japan – Japanese regulators extend Medical Device Single Audit Program (MDSAP) pilot

Japan’s Ministry of Health, Labour and Welfare (MHWL) has updated its processes and procedures for accepting quality management system (QMS) audit reports from medical...
TGA Creates Advertising Guidance for Providers of Cell and Tissue Products

Australia – Classification of active medical devices (including software-based medical devices)

This guidance is to assist manufacturers of active medical devices, including software-based medical devices, in correctly classifying their devices.

Australia – Australian regulators plans up-classification of medical devices targeting circulatory, nervous systems

The Australian Therapeutic Goods Administration (TGA) has issued new guidance on plans to reclassify medical devices involved in circulatory and nervous systems from Class...

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