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There are significant changes in store for New Zealand’s medical device sector, including a new regulator and a set of pre- and post-market regulatory controls.
A new regulation in China legalizes overseas inspections of device- and drug-makers, making risk-based audits routine tasks.
The list of medical device approvals outside the US captured by Medtech Insight's Approvals Tracker in 2018 was shorter than in 2017, but it includes approvals from 14 different territories – more than one-fifth of the approvals came from emerging markets – covering more than 50 different indication categories.
Australia's Therapeutic Goods Administration also wants to extend the scope of the products it regulates as medical devices to include the non-medical-use products now captured in the new EU Medical Device Regulation.
The Therapeutic Goods Administration wants to introduce a unique device identification (UDI) system in Australia and align its implementation with the transitional arrangements for a similar system in the EU.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Twenty-three new guidance documents have been posted on the tracker since its last update.
The ground is shifting across Asia when it comes to how medical devices and diagnostics are regulated. Reforms throughout the region were evident in Medtech Insight's top 15 Asia regulatory and policy stories from 2018.
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