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The Therapeutic Goods Administration has developed an electronic application system for export certificates after sponsors said they were experiencing problems with getting their certificates notarized and endorsed.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Twenty-two new guidance documents were posted on the tracker since its last update.
Johnson & Johnson is caught in the eye of a storm in India, after an expert panel recommended compensation for patients affected by its 'faulty' ASR hip implants. A stinging report by the panel raises several questions around J&J’s alleged “lack of seriousness” in addressing the issue - charges that the company denies - though it remains to be seen how the Indian government ensures that Indian patients get a fair deal.
Australia has decided to make greater use of medical device approvals in overseas markets to improve consumer access.
Medical devices for use by professional users in Australia can now be supplied exclusively with electronic instructions for use.
The Indian government is seeking feedback on a draft guidance document that covers everything industry needs to know about the country’s regulatory requirements for medtech products.
Asian Medtech Update: Thai Device Law Latest; National Issues Aired; ASEANMed Seeks Medtech Industry Role At AMDC
This month's Asian Medtech Associations' regulatory networking discussions cover the current progress of the Thai medical device regulation, which must be in place before the national elections; Vietnam's efforts to introduce practical, workable device regulations; ASEANMed's aims to represent the regional industry at AMDC; and other ASEAN national updates. This series is hosted by Medtech Insight and sponsored by the Asia Regulatory Quality Consultancy (ARQon) and the Asia Regulatory Professionals Association (ARPA).
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