Cyber security for medical devices and IVDs

Australia – Cyber security for medical devices and IVDs

Cybersecurity is an important consideration for medical devices and IVD medical devices (IVDs). We have produced guidance specific to industry as well as guidance...
Breast implants and anaplastic large cell lymphoma

Australia – Breast implants and anaplastic large cell lymphoma

This update reflects the TGA's initial views following recent laboratory testing and statistical analysis. Breast implant sponsors have until 24 July to provide additional...
Chinese regulators preparing medical device UDI pilot

China – Chinese regulators preparing medical device UDI pilot

The National Medical Products Administration (NMPA), China’s medical device market regulator, has begun laying the groundwork for a Unique Device Identification (UDI) pilot program...
Chinese regulators preparing medical device UDI pilot

China – Chinese NMPA update: eRPS, predicate device data, technical review guidelines

China’s National Medical Product Administration (NMPA) has clarified various technical review and information guidelines related to medical device registration and approval. Requests for predicate device...
MFDS rolls out new regulation for IVD devices

South Korea – MFDS rolls out new regulation for IVD devices

The South Korean Ministry for Food and Drug Safety (MFDS) has established new regulations for registration of IVD products in order to improve oversight...
Process chart: Medical device & IVD registration requirements in Malaysia

Maylasia – Process chart: Medical device & IVD registration requirements in Malaysia

Foreign manufacturers entering the Malaysian market will be able to leverage their existing approvals in recognized reference markets (Australia, Canada, European Union countries, Japan,...
TGA Creates Guidance on Device Standards for Quality Management Systems

Australia – TGA Creates Guidance on Device Standards for Quality Management Systems

The Therapeutic Goods Administration (TGA) has created guidance to help companies comply with a medical device law passed in Australia earlier this year. The...
Updates to variations to prescription medicines guidance and e-form

Australia – Guidance on Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order...

Two key requirements of the conformity assessment procedures for medical devices are that a manufacturer must implement: a Quality Management System (QMS) for the...
Japanese firm develops assay with integrated circuit for cancer detection

Japan – Japanese firm develops assay with integrated circuit for cancer detection

Toray has developed an IC that can detect certain microRNA that occurs with cancer. Cancer cells  produce different kinds of microRNA which are specific to...
Chinese regulators preparing medical device UDI pilot

China – China’s NMPA reports major decrease in medical device approvals

The Chinese National Medical Products Administration (NMPA) has published new data showing a 38% decline in medical device registrations approved by the agency in...

NOS PROCHAINES FORMATIONS