Australia ’ s TGA looks to strengthen medical device oversight

Australia’s Therapeutic Goods Administration yesterday released a three-part action plan looking to strengthen the company’s medical device regulatory system. The plan includes steps to improve oversight of new devices entering the market, strengthening post-market monitoring and providing more device information to patients. The changes are slated to take effect in early-to-mid 2019 and continue into 2020, according to the official TGA posting. The changes include open public consultations to seek feedback on the proposals, the TGA said, adding that decisions on specific policies and regulations would need to be made by the government. The TGA said that currently, very low risk devices can be self certified, while all other devices must be assessed by a qualified body to show it meets the country’s “Essential Principles.” Some medium risk devices are also subject to further assessments, while high risk devices must either be examined by the TGA or subjected to a detailed audit by the TGA prior to it becoming available in Australia. In its new proposal, the TGA said that it will look to reassess whether self-certification of low risk devices is appropriate as well as establishing a specialist unit to evaluate emerging tech including 3D-printed devices and software applications. The group will also look to provide clearer guidance on cybersecurity requirements for connected medical devices and IT systems, according to the release. The TGA said that it will al...
Source: Mass Device - Category: Medical Devices Authors: Tags: Featured Regulatory/Compliance Source Type: news