Australian regulatory action on breast implants and breast tissue expanders

Australia – Consultation: Proposed regulatory options for medical devices containing nanomaterials

The Australian Government is undertaking a significant program of reform to the regulation of therapeutic goods in Australia. The reforms will continue to improve...
TGA suspends overseas GMP inspections and QMS audits until further notice

Australia – Regulatory framework for personalised medical devices: Frequently asked questions

The Therapeutic Goods Administration (TGA) has compiled these frequently asked questions to further clarify the new regulatory framework for personalised medical devices. These questions...
CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

India – Indian regulators propose use of American Standard Test Methods for medical device...

India’s Ministry of Health and Family Welfare has proposed recognizing American Standard Test Methods (ASTM) as acceptable tools for demonstrating conformance of medical devices...

Australia – Clinical decision support software

From 25 February 2021, the way that software-based medical devices are regulated in Australia will change. Information about the changes can be found in Regulatory...
Australian regulatory action on breast implants and breast tissue expanders

Australia – TGA carves out exemptions for some software-based medical devices

Australia’s Therapeutic Goods Administration (TGA) has published the Therapeutic Goods (Excluded Goods) Amendment (Software-Based Products) Determination 2021, which will become effective on February 25, 2021....

China – Chinese regulators announce classification adjustments and UDI submission guidelines

Two important updates for regulation of medical devices in China were announced near the change in the calendar year. The first relates to classification...
TGA Creates Advertising Guidance for Providers of Cell and Tissue Products

Australia – Regulation of software based medical devices : Update

The Governor-General in Council has made regulations which delay the commencement of a number of medical device reforms in Australia. This delay reflects the...
TGA Creates Advertising Guidance for Providers of Cell and Tissue Products

Australia – Face masks and COVID-19

The Therapeutic Goods Administration (TGA) publishes information and resources about face masks for consumers, health professionals and industry. This page compiles all of our...

Australia – TGA confirms nicotine e-cigarette access is by prescription only

From 1 October 2021, the law for consumers to import nicotine e-cigarettes and liquid nicotine will align with the law for them to buy...

China – NMPA guidances address real-world data, medical device naming, and IVD technical review

China’s National Medical Products Administration (NMPA) published a number of guidance documents pertaining to medical devices and IVDs recently. Noteworthy examples include guidelines on...

NOS PROCHAINES FORMATIONS