Worldwide medical device QA/RA blog

News and commentary on regulatory changes.

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That is why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you.

FDA Clarifies Early Feasibility Study (EFS) Program for Early-stage Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has provided qualification and submission details for its Early Feasibility Study (EFS) program.
  • The EFS program targets novel and innovative devices for which little or no prior clinical and non-clinical data exist.
Read more about FDA Clarifies Early Feasibility Study (EFS) Program for Early-stage Medical Devices...

Quick Take: What FDA Medical Device User Fee Reauthorization Means for Registrants

EMERGO SUMMARY OF KEY POINTS:

  • US legislators and President Trump have finally signed off on FDA user fee reauthorizations that will remain in place through 2022.
  • The FDA Reauthorization Act of 2017 (FDARA) keeps current agency funding mechanisms—user fees as well as appropriations from Congress—in place.
Read more about Quick Take: What FDA Medical Device User Fee Reauthorization Means for Registrants...

FDA Adds UL 2900 for Medical Device Cybersecurity to List of Recognized Standards

EMERGO SUMMARY OF KEY POINTS:

  • The US FDA has now officially recognized the UL 2900 cybersecurity standard for medical devices.
  • UL 2900-1 covers general cybersecurity requirements for network-connectable devices.
  • FDA medical device applicants may now declare conformity to UL 2900-1 in order to address cybersecurity requirements as part of their US market registration.
Read more about FDA Adds UL 2900 for Medical Device Cybersecurity to List of Recognized Standards...

Singapore HSA Establishes Priority Review for Qualifying Medical Devices

EMERGO SUMMARY OF KEY POINTS

  • Singapore’s Health Sciences Authority (HSA) has launched a priority review scheme for qualifying medium- to high-risk medical devices.
  • The new registration route provides faster Singapore market access for devices that address key HSA healthcare areas; are novel; or that target unmet clinical needs.
  • Class A devices as well as some combination products do not qualify for the new registration route.
Read more about Singapore HSA Establishes Priority Review for Qualifying Medical Devices...

FDA Pre-Cert Pilot for Medical Software: Key Questions and Eligibility Criteria

EMERGO SUMMARY OF KEY POINTS:

  • The US FDA will begin its Pre-Certification for Software (Pre-Cert) pilot program for digital health technologies considered medical devices in September 2017.
  • Eligibility requirements for Pre-Cert participation as well as frequently asked questions have been published.
  • As of now, US regulators have not set a deadline for applying to participate in the Pre-Cert program.
Read more about FDA Pre-Cert Pilot for Medical Software: Key Questions and Eligibility Criteria...

CFDA Proposal Would Require Chinese Translations of Foreign Medical Device Applicants' Company Information

EMERGO SUMMARY OF KEY POINTS:

  • Chinese medical device regulators want to require foreign registrants’ company names and addresses to be provided in Chinese.
  • New Chinese market applicant would be impacted by this requirement starting in January 2018.
  • Existing CFDA registrants would have to comply by the end of 2018.
Read more about CFDA Proposal Would Require Chinese Translations of Foreign Medical Device Applicants' Company Information...

TÜV SÜD Extends Compliance Deadlines for MEDDEV 2.7/1 Rev. 4

EMERGO SUMMARY OF KEY POINTS

  • Requirements for demonstrating state of the art under MEDDEV 2.7/1 Rev. 4 are more specific than those in the current Medical Devices Directive (MDD)
  • The MEDDEV is not legally binding
  • TÜV SÜD has decided to extend implementation of MEDDEV 2.7/1 Rev. 4 until the date of application of the Medical Devices Regulation. Until then following Rev. 3 is deemed sufficient.
Read more about TÜV SÜD Extends Compliance Deadlines for MEDDEV 2.7/1 Rev. 4...

Compliance Deadlines Approaching for Malaysian Medical Device Registration

EMERGO SUMMARY OF KEY POINTS:

  • Malaysian regulators at the MDA have set two registration-related deadlines for companies whose market applications are still being processed.
  • Late October 2017 and early January 2018 deadlines will impact Malaysian market registrants whose applications are still under regulatory or Conformity Assessment Body review.
Read more about Compliance Deadlines Approaching for Malaysian Medical Device Registration...

Brazilian Regulators Propose Extending Validity Timeframes for Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • ANVISA intends to move medical device registration validity timeframes from five to 10 years.
  • Expanded validity timeframes should result in lower ongoing compliance costs for Brazilian market registrants.
  • The ANVISA proposal will undergo finalization following a 60-day comment period.
Read more about Brazilian Regulators Propose Extending Validity Timeframes for Medical Devices...

Chinese FDA Answers Two Common Clinical Trial Questions

EMERGO SUMMARY OF KEY POINTS:

  • Chinese medical device regulators have addressed frequently asked questions about clinical trial timeframes and filing requirements.
  • The CFDA appears to have stepped up actions and clarifications regarding clinical trial requirements and policies in recent months.
Read more about Chinese FDA Answers Two Common Clinical Trial Questions...

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