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Asia Pacific

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Australia Streamlines Export Certificate Application System

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.

Trade Policy & Regulation Australia
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Global Medtech Guidance Tracker: August 2018

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.

International Medical Device

Hips Don’t Lie: J&J Faces Compensation Maelstrom In India Over Faulty ASR Implants

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.

India Orthopedics

Australia Accepts Approvals By More 'Comparable' Overseas Regulators/Bodies

Australia has decided to make greater use of medical device approvals in overseas markets to improve consumer access.

Australia Policy & Regulation

Less Burden For Medtech As Australia Adopts Electronic IFU

Medical devices for use by professional users in Australia can now be supplied exclusively with electronic instructions for use.

Policy & Regulation Australia

India Releases ‘Essential Reference Manual’ On Devices And IVDs

The Indian government is seeking feedback on a draft guidance document that covers everything industry needs to know about the country’s regulatory requirements for medtech products.

Policy & Regulation India

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).

ASEAN Thailand
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