Regulatory Focus™ > News Articles > TGA Implements International Device Inspection Program

TGA Implements International Device Inspection Program

Posted 03 December 2012 | By Alexander Gaffney, RAC 

Australia's Therapeutic Goods Administration (TGA) is implementing the Medical Device Single Audit Program (MDSAP), which aims to strengthen existing international cooperation in the field of medical device evaluation.

The MDSAP is an initiative of the Medical Device Single Audit Program Working Group (MDSAP) of the International Medical Device Regulators Forum (IMDRF), which is the successor group to the Global Harmonization Task Force (GHTF).

In furtherance of MDSAP, TGA has signed a Statement of Cooperation on the MDSAP with the United States Food and Drug Administration (FDA), the Brazilian Health Surveillance Agency (ANVISA), and the Canadian Health Products and Food Branch (HPFB).

TGA officials said the program will "provide for more effective, efficient and less burdensome regulatory oversight of the quality management systems of medical device manufacturers."


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