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As China is poised to supply medical products to fight the coronavirus around the world, a battle to banish its image of poor product quality is on.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Sixty-nine guidance documents have been posted on the tracker since its last update.
The Australian health care products regulator is inviting feedback on proposed measures to clarify the boundary for software-based products that are captured under the regulatory framework for medical devices.
Medtech manufacturers around the globe should brace for another shock to supply chains now that the COVID-19 pandemic has shifted away from Asia, and toward North America and Europe.
Chinese monitoring of the spread of COVID-19 locally has reported no new cases of home-grown infection in a single day for the first time since the outbreak began. It indicates control efforts, including the NMPA’s fast-tracking of relevant devices, PPE and IVDs, are having the desired effects.
The Philippines FDA says no company has applied to import and register diagnostic test kits for the novel coronavirus.
Thailand has opted to align with IMDRF principles on the classification of devices. The change also brings the Thai FDA into line with Asean Medical Device Directive principles.
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