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.

New US FDA Guidance: How to Utilize the Dual 510(k) and CLIA Waiver IVD Market Pathway

EMERGO SUMMARY OF KEY POINTS:

  • New FDA recommendations issued for IVD manufacturers using the Dual 510(k) and CLIA Waiver by Application registration pathway.
  • The FDA’s Dual Submission pathway allows IVDs to reach the US market faster than if registrants obtain 510(k) clearance and then CLIA waived categorization in a stepwise process.
  • The Dual Submission registration pathway is best suited for simple IVDs  subject to 510(k) rather than Premarket Approval (PMA) review.
Read more about New US FDA Guidance: How to Utilize the Dual 510(k) and CLIA Waiver IVD Market Pathway...

European NBOG Designation Codes for Notified Bodies Officially Released

EMERGO SUMMARY OF KEY POINTS:

  • Notified Body designation codes for the Regulations are now officially released.
  • There are some minor differences in the list for medical devices.
  • The list for IVDs has been reduced by 20 codes.
  • Manufacturers can now list the NBOG codes that are relevant for them.
Read more about European NBOG Designation Codes for Notified Bodies Officially Released...

New Harmonized Medical Device, IVD Standards Published in Europe

EMERGO SUMMARY OF KEY POINTS:

  • European regulators have published updated harmonized standards applicable to the Medical Device Directives in the Official Journal of the European Union.
  • The updated list of standards replaces the EN 980 labeling standard with EN ISO 15223 starting in early 2018.
  • The European list of harmonized standards was last updated in May 2016.
Read more about New Harmonized Medical Device, IVD Standards Published in Europe...

Official Roadmap for European MDR, IVDR Compliance: Key Priorities

EMERGO SUMMARY OF KEY POINTS:

  • European Competent Authorities’ new roadmap lists implementation and compliance priorities for new Medical Device Regulations (MDR) and In-vitro Diagnostics Regulations (IVDR).
  • The roadmap priorities suggest regulators are aware of which implementation areas present the biggest challenges for industry.
  • Implementation timelines have not been included in the new roadmap, however.
Read more about Official Roadmap for European MDR, IVDR Compliance: Key Priorities...

More Details on Changes to China FDA Medical Device Clinical Requirements

EMERGO SUMMARY OF KEY POINTS:

  • The China Food and Drug Administration (CFDA) has published new technical guidance on accepting medical device clinical data from sources outside China.
  • Foreign clinical data used in CFDA registration applications must meet China Good Clinical Practice requirements.
  • Chinese market registrants should notify CFDA before submitting applications that they intend to use foreign clinical data in their applications.
Read more about More Details on Changes to China FDA Medical Device Clinical Requirements ...

Encryption, FIPS 140 and Medical Devices: Frequently Asked Questions

EMERGO SUMMARY OF KEY POINTS:

  • Pressure from US regulators and healthcare purchasing organizations for medical devices to demonstrate adequate encryption capabilities is increasing.
  • Compliance with the Federal Information Publications Standard (FIPS) 140-2 standard enables manufacturers to demonstrate adequate encryption tools for their devices.
  • FIPS 140-2 compliance is best addressed early in the medical device design phase.
Read more about Encryption, FIPS 140 and Medical Devices: Frequently Asked Questions ...

Brazil’s ANVISA Proposing Easier Market Pathway for Low-risk Medical Devices and IVDs

EMERGO SUMMARY OF KEY POINTS:

  • Brazil’s ANVISA plans to replace cadastro registration requirements for Class I medical devices and IVDs with a notification system for faster market access.
  • Class I devices undergoing notification instead of cadastro review would bypass technical analysis.
  • Additional public consultations and regulations will need to be published before ANVISA’s notification system comes into force.
Read more about Brazil’s ANVISA Proposing Easier Market Pathway for Low-risk Medical Devices and IVDs ...

MDMA or MDNR: Which Saudi Arabian Registration Route is Better for Low-risk Medical Devices?

EMERGO SUMMARY OF KEY POINTS

  • Low-risk medical device manufacturers may now choose between Medical Device Market Application (MDMA) and Medical Device National Registry (MDNR) registration pathways in Saudi Arabia.
  • The SFDA’s MDNR route is faster, but some Class I non-sterile, non-measuring device manufacturers may still benefit more by undergoing MDMA registration.
Read more about MDMA or MDNR: Which Saudi Arabian Registration Route is Better for Low-risk Medical Devices?...

China FDA Expands List of Higher-Risk Devices Exempt from Clinical Trial Requirements

EMERGO SUMMARY OF KEY POINTS:

  • CFDA has proposed adding more Class II and III medical devices and IVDs to its clinical trial exemption list.
  • The regulator has already exempted more than 300 Class II and about 100 Class III devices from clinical trial requirements.
  • CFDA registrants qualifying for these exemptions may submit clinical data obtained outside China for market application purposes.
Read more about China FDA Expands List of Higher-Risk Devices Exempt from Clinical Trial Requirements...

Health Canada Pushes for Reduced MDSAP Audit Timeframes

EMERGO SUMMARY OF KEY POINTS:

  • Medical Device Single Audit Program (MDSAP) audit timeframes have been reduced in response to industry feedback received by Health Canada.
  • MDSAP audit time reductions will primarily target smaller medical device companies with limited regulatory compliance resources.
  • All MDL holders active in the Canadian market will have to comply with MDSAP by early 2019.
Read more about Health Canada Pushes for Reduced MDSAP Audit Timeframes ...

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