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  • Australian TGA Releases New Clinical Guidelines for Medical Devices
  • EMERGO SUMMARY OF KEY POINTS: The Australian TGA has published more detailed guidance on clinical evidence requirements for medical devices and IVD products. TGA clinical evidence requirements are based on GHTF standards and European MEDDEV documents. Australian regulators may demand clinical evidence from medical device and IVD registrants at any time, not just during premarket review.
    Thursday, March 23, 2017

  • India Authorized Agent Role Changes under New Medical Device Rules
  • EMERGO SUMMARY OF KEY POINTS: India’s new Medical Device Rules include expanded responsibilities for India Authorized Agent in-country representatives. India Authorized Agents will have added importation responsibilities, and CDSCO will allow multiple Agents for imported devices. Agent role changes will go into effect assuming that Indian regulators are able to meet their own early 2018 implementation timeframe.
    Wednesday, March 22, 2017

  • Common Medical Device QMS Audit Problems: Little or No Audit Preparation
  • EMERGO SUMMARY OF KEY POINTS: Despite best intentions, medical device companies’ internal audits are often carried out as last-minute affairs. Formalized audit preparation time, adherence to checklists and simple time management can help a firm’s audit personnel perform their duties more effectively.
    Tuesday, March 21, 2017

  • Proposed US FDA User Fee Increase would Impact Smaller Medical Device Firms the Most
  • EMERGO SUMMARY OF KEY POINTS: The Trump Administration has proposed user fee increases for drug, medical device and other FDA registrants in 2018. Few specifics on the proposed increases make it difficult to determine exactly how medical device firms would be impacted. Smaller manufacturers make up the vast majority of the US medical device industry, and would be most substantially affected by higher FDA fees.
    Monday, March 20, 2017

  • Emergo Survey: Most Medical Device Firms Need Better Understanding of European MDR, IVDR
  • EMERGO SUMMARY OF KEY POINTS: Most QA/RA survey respondents report only basic familiarity with new medical device and IVD regulations in Europe. Larger firms with more QA/RA resources claim more thorough understanding of MDR and IVDR requirements. Publishing of MDR and IVDR final versions will likely lead to more companies focusing on what the new regulations will mean for their CE Marking compliance.
    Friday, March 17, 2017

  • Malaysia Update: ASEAN ratification, Medical Device Regulation revisions on the way
  • EMERGO SUMMARY OF KEY POINTS Malaysia plans to ratify the ASEAN Medical Device Directive (AMDD) in mid-2017. The Malaysian Medical Device Authority (MDA) plans to publish several new guidance documents in the near future. MDA plans to overhaul Malaysia’s medical device regulatory system are underway.
    Friday, March 17, 2017

  • Emergo Study: FDA 510(k) Submissions from US Companies on the Decline
  • EMERGO SUMMARY OF KEY POINTS: US medical device manufacturers are submitting 510(k) applications to the FDA less frequently than in previous years. Due to currency and other issues, 510(k) submissions from foreign companies have increased. Overall, numbers of 510(k) submissions have fallen over the past three years, while review times have increased.
    Tuesday, March 14, 2017

  • 337 Devices May Now be Exempt from US FDA 510(K) Requirements
  • EMERGO SUMMARY OF KEY POINTS: The US FDA has proposed exempting hundreds of Class II medical devices from 510(k) requirements. The exemptions are part of the 21st Century Cures Act, passed in late 2016. Newly exempt devices will still need to meet other FDA regulations such as 21 CFR Part 820.
    Tuesday, March 14, 2017

  • Common QMS Audit Problems: No Management Support
  • EMERGO SUMMARY OF KEY POINTS: Getting management buy-in for medical device QMS audits can be a challenge at many firms. Audit personnel at device manufacturers should emphasize audits as essential business practices to gain support from senior executives. Audit reports should highlight specific risk mitigation and cost saving benefits to senior management.
    Friday, March 10, 2017

  • Brazil ANVISA: Half of Some High-risk Medical Device Registration Submissions Rejected in 2016
  • EMERGO SUMMARY OF KEY POINTS: Brazilian regulators rejected nearly half of all registration applications for some high-risk medical devices in 2016. ANVISA rejected 14% more “material registro” applications in 2016 than in 2015. Fewer medical device and IVD registration applications were submitted to ANVISA in 2016 than in previous years, due to economic as well as regulatory factors.
    Tuesday, March 07, 2017

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