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  • RoundupsRoundups

    Asia-Pacific Roundup: TGA releases risk classification guidance for active medical devices

    TGA releases guide to classifying active medical devices by risk   New guidance from Australia’s Therapeutic Goods Administration (TGA) on the risk classification of active medical devices covers software-based products and other medical devices that act by converting energy. Examples of covered devices include pacemakers and phototherapy devices.   The EU defined the term “active medical device” in its Medical Device Regulation (MDR). TGA, which follows the EU w...
  • RoundupsRoundups

    Asia Regulatory Roundup: Pakistan Seeks Expert to Help Harmonize Regulations With Global Best Practices

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   New Zealand Extends Timelines for Reporting Medical Device Adverse Events   The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has given companies more time to report adverse events involving their medical devices.   Under the old rules, manufacturers of medical devices had seven calendar days to report incidents of actual or potential death...
  • RoundupsRoundups

    Asia Regulatory Roundup: TGA Offers Advice on Managing Shortages Triggered by Ranitidine Recalls

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Offers Advice on Managing Shortages Triggered by Ranitidine Recalls   Australia’s Therapeutic Goods Administration (TGA) has advised physicians about how to manage the shortages created by recalls of ranitidine medicines. The notice follows decisions by eight companies to recall batches of ranitidine medicines in response to contamination concerns.   TGA firs...
  • Regulatory NewsRegulatory News

    New Zealand to Overhaul Regulatory System, Will Rely on Other Regulators' Approval of 'Cutting Edge' Products

    The government of New Zealand is working to completely overhaul its regulatory system for healthcare products by drafting new legislation to replace the country's Medicines Act of 1981 . The major changes being proposed are intended to modernize New Zealand's regulatory system by making it more flexible and efficient, while filling in "significant gaps in coverage" for medical devices and cell and tissue therapies. The plan would also allow New Zealand to recognize the...
  • Regulatory NewsRegulatory News

    Oceania Regulator ANZTPA Shut Down by Australia and New Zealand

    Australian and New Zealand officials have confirmed they plan to stop development of the Australia New Zealand Therapeutics Products Agency ( ANZTPA ), a joint regulatory authority meant to more efficiently regulate healthcare products in both countries. Background The ANZTPA has been under development since at least 2011, and had reached several notable milestones since 2012. In September 2012, it put out a call to  harmonize over-the-counter drug regulations , and  co...