Due to safety issues identified in the classification of certain medical devices and to further harmonize to the European Union medical devices framework, the Australian TGA is considering changing their classification rules to safeguard patients, harmonize requirements, facilitate smooth operation of the market and ensure timely access to medical devices.
Changes introduced in 2019
On December 12, 2019, The Therapeutic Goods Legislation Amendment (2019 Measures No.1) amended the 2002 Regulations and reclassified six categories of medical devices:
|Medical Devices Reclassified in 2019||Consultation Status|
|medical devices that consist of substances introduced into the body via a body orifice or applied to the skin||Consultation opened 16 July 2021|
|active medical devices for therapy with diagnostic function||Consultation closed 29 April 2019|
|active implantable medical devices and their accessories||Consultation closed 29 April 2019|
|medical devices that administer medicines or biologicals by inhalation||Consultation closed 29 April 2019|
|spinal implantable medical devices||Consultation closed 29 April 2019|
|medical devices used in direct contact with the heart, central circulatory or central nervous systems.||Consultation closed 29 April 2019|
The TGA will continue to consult regarding the proposed medical device classification for storage solutions for human cells, tissues and organs, and IVF media in order to clarify issues raised in submissions, prior to considering regulatory amendments for this category of devices.
Guidance for industry
Guidances are in development to include further information about the reclassifications and transitional arrangements for devices that are currently included in the ARTG. Further information and guidance about the new classification rules and transitional arrangements will be published as it becomes available.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.