Australia Blog Posts

Australian Regulators Plan Improved Patient Access, Reimbursement for Prosthetic Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • Australian regulators to publish Prostheses List three times per year starting in 2019
  • Private insurers as well as prosthetic device manufacturers active in Australia will be impacted
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Australian TGA Adopts Priority Review Approach for Medical Devices and IVDs

EMERGO KEY POINTS:

  • New Australian TGA guidance establishes a priority review designation pathway for cutting-edge and novel medical devices and IVDs.
  • Qualifying devices must meet criteria pertaining to serious diseases or conditions, unmet clinical needs and breakthrough technologies.
  • TGA decisions on priority review designation applications will take no more than 20 business days.
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Changes to Australian Medical Device Recall Process Set for Early 2018

EMERGO SUMMARY OF KEY POINTS:

  • Updates to the Australian TGA’s medical device recall process will come into effect in January 2018.
  • The updated TGA recall process includes guidelines for determining recall versus non-recall actions.
  • TGA registrants should take advantage of a “familiarization period” between now and the recall updates’ effective date of January 15, 2018.
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In Brief: US FDA, Brazil ANVISA Expand Lists of Qualified Audit Organizations for MDSAP

EMERGO SUMMARY OF KEY POINTS:

  • US and Brazilian medical device market regulators have updated their lists of organizations authorized to conduct QMS audits under the Medical Device Single Audit Program (MDSAP).
  • There are now four companies recognized as MDSAP auditing organizations and 13 organizations authorized by the US FDA to carry out audits.
  • Brazil’s ANVISA now recognizes nine MDSAP audit organizations.
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Australian TGA to Take Over Medical Device Advertising Complaint Oversight in 2018

EMERGO SUMMARY OF KEY POINTS:

  • Australian advertising complaint oversight for medical devices and drugs will be consolidated under the Therapeutic Goods Administration.
  • Full TGA oversight will begin in July 2018.
  • Additional advertising requirement reforms for medical devices are planned for 2018.
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Australian Regulators Want Faster Market Access for Some Devices Approved Overseas

EMERGO SUMMARY OF KEY POINTS:

  • The Australian TGA is developing a market access pathway whereby medical devices approved by certain overseas regulators would gain Australian market access without undergoing additional conformity assessments.
  • The TGA has not yet determined which overseas regulatory approvals would be included in the new program.
  • Amendments to existing laws concerning Australian medical device regulation will be introduced throughout 2017 to facilitate implementation of the new pathway.
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Australian TGA Seeks Broader Penalty Powers for Medical Device Advertising Violations

EMERGO SUMMARTY OF KEY POINTS:

  • The Australian Therapeutic Goods Administration (TGA) is seeking additional sanction and penalty powers against medical device and drug companies violating advertising rules.
  • Proposed sanction and penalty tools would allow punishments more commensurate with severity of advertising violations.
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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.
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MDSAP Update: Lukewarm Interest among Australian Medical Device Companies

EMERGO SUMMARY OF KEY POINTS:

  • The Medical Device Single Audit Program (MDSAP) ended its pilot phase and became fully implemented in January 2017 in the United States, Canada, Brazil, Australia and Japan.
  • In Australia, only larger medical device manufacturers have shown interest in MDSAP so far.
  • Smaller Australian manufacturers have yet to be sold on MDSAP’s benefits.
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Australian Government Accepts Proposals for Multiple Market Pathways for Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • The Australian Department of Health has accepted expert panel recommendations to establish multiple market pathways for medical device registrants.
  • Expedited approvals and Therapeutic Goods Administration recognition of market authorizations from foreign regulators are included in the recommendations.
  • The Australian government plans to begin implementing regulatory reforms in 2016 and 2017.
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