Chinese NMPA publishes UDI system rules for medical device registrants

China – Chinese NMPA publishes UDI system rules for medical device registrants

The National Medical Products Administration (NMPA), China’s medical device market regulator, has published official Unique Device Identification (UDI) requirements that will take effect October...
Medical device incident reporting (MDIR) guide

Australia – Medical device incident reporting (MDIR) guide

Welcome to the Medical Device Incident Reporting (MDIR) system. This is just one of a number of systems accessible from the TGA Business Services...
TGA’s UDI Proposal Gets Broad Industry Support

Australia – TGA’s UDI Proposal Gets Broad Industry Support

The medtech industry has voiced broad support for the Therapeutic Goods Administration’s (TGA) plans to adopt a unique device identifier (UDI) system in Australia....
Regulatory chart: Medical device & IVD registration in Singapore

Singapore – Regulatory chart: Medical device & IVD registration in Singapore

In Singapore, medical devices are overseen by the Health Sciences Authority (HSA). Classification of devices is similar to the system in Europe, but there...
Advertising therapeutic goods: Natural claims on medicines and medical devices: naturally compelling?

Australia – Advertising therapeutic goods: Natural claims on medicines and medical devices: naturally compelling?

Advertisers of medicines and medical devices sometimes promote on labels and in other advertising that their product is ‘natural’ or contains ‘natural’ ingredients. Variations...
Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs)

Australia – Use of market authorisation evidence from comparable overseas regulators / assessment bodies...

The purpose of this document is to provide an overview of how specific overseas assessments and approvals can be used by applicants for the...
US-China trade war unlikely to shift manufacturing to US

China – US-China trade war unlikely to shift manufacturing to US

The U.S.-China trade war is certainly affecting where U.S. medical device companies decide to make their products. But don’t expect a bunch of manufacturing...
Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs)

Australia – Thermography should not be relied on for early detection of breast cancer

The TGA is urging consumers not to rely on unproven breast imaging technologies, such as breast thermography, to detect breast cancer. Breast thermography, also known...
Medical device incident reporting (MDIR) guide

Australia – Australian TGA finalizes medical device and IVD cybersecurity guidance

Australia’s Therapeutic Goods Administration (TGA) has implemented final guidance on pre- and post-market cybersecurity regulatory recommendations for medical device, software and IVD manufacturers and...
The convergence of medical device cybersecurity requirements in Australia, Canada and the USA

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...

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