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  • Regulatory NewsRegulatory News

    New Electronic Formatting Requirements in Canada for Class III and IV MDL Applications

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Health Canada, Canada’s medical device market regulator, has published new  guidance  requiring electronic formatting for most higher-risk Class III and IV Medical Device License (MDL) applications. Set to take effect 1 December 2014, the new rules will require Class III and IV MDL applicants to submit premarket review documentation...
  • Regulatory NewsRegulatory News

    Major Changes to Medical Device Registration Process in Japan

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Revised medical device registration and approval requirements in Japan will become law 25 November 2014 and will impact several compliance areas for foreign manufactures active in the market, according to Emergo’s Tokyo office. Replacing the Pharmaceutical Affairs Law (PAL), the Pharmaceutical and Medical Device Law (PMDL) will ...
  • Regulatory NewsRegulatory News

    Australian Government Proposes Bypassing TGA for Medical Devices with CE Marking

    Content provided by Emergo Group, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The Australian government under Prime Minister Tony Abbott has proposed allowing domestic medical device manufacturers to register their “routine” products in the country using CE Marking certificates from European Notified Bodies. The proposal, part of a new government  position paper pushing innovation and competitiveness issues, wou...
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    Latest Information on Health Canada Review and Approval Times for MDEL Applications

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Health Canada regularly publishes performance data with respect to Medical Device License applications (Class 2-4); however, the data publically available for Medical Device Establishment License (MDEL) applications has generally been limited.  To gain a better understanding of MDEL applications, Emergo's Vancouver office contacted H...
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    New COFEPRIS Guidance on Technovigilance Report Submissions

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Mexico’s medical device market regulator COFEPRIS has issued new guidance on its  technovigilance reporting program  (link in Spanish) for medical device manufacturers commercialized in the country. First  announced  in early 2013, the technovigilance system will support post-market device monitoring and management of adverse even...
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    EU Notified Bodies Update Code of Conduct

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The European Association for Medical Devices of Notified Bodies (Team-NB) has published an updated Code of Conduct targeting more consistent and transparent CE Mark certifications from member firms. First implemented by Team-NB in early 2013, the Code of Conduct’s version 3.2 makes more explicit processes and procedures Notified B...
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    Australian TGA Taking a More Discerning Approach to Notified Bodies

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The Australian Therapeutic Goods Administration (TGA) plans to conduct application audits  for medical devices seeking entry into the Australian Register of Therapeutic Goods (ARTG) using conformity assessments from several Notified Bodies. The TGA move could cause delayed Australian market entry for manufacturers that have used the...
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    Digging Deeper into China's New Medical Device Registration Requirements

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Emergo Group colleagues in China have provided additional details on recently published changes to the China Food and Drug Administration’s (CFDA) medical device registration process. CFDA  Administrative Order No. 4  covers new and revised requirements for Class I, II and III device registrations in China that will take effec...
  • Regulatory NewsRegulatory News

    New Chinese Medical Device, IVD Regulations Take Effect in October 2014

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Chinese medical device market regulators have published long-awaited updates to medical device as well as in vitro diagnostic device and labeling requirements that will go into force 1 October 2014. First, China Food and Drug Administration (CFDA)  Administrative Order No. 4  (link in Chinese) encompasses multiple areas of medical dev...