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.

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 ...

Final FDA Guidance on When Medical Device Changes Require New 510(k) Submissions

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has issued final guidance documents for changes to medical device hardware and software that require new 510(k) applications.
  • The final guidances do not differ substantially from draft versions published in 2016.
Read more about Final FDA Guidance on When Medical Device Changes Require New 510(k) Submissions...

How Europe Plans to Address Orphaned Medical Device Manufacturers and NB De-notification

EMERGO SUMMARY OF KEY POINTS:

  • European Member States have adopted a procedure for “orphaned manufacturers” that the Dutch Competent Authority IGJ has implemented already.
  • Manufacturers who are affected by the scope reduction of their Notified Bodies can be eligible for a “period of grace.”
  • Application needs to be submitted in the European Member State where the manufacturer or AR is based.
  • NANDO has been updated with AIMD, IVDD and MDD scopes of NBs.
Read more about How Europe Plans to Address Orphaned Medical Device Manufacturers and NB De-notification...

US FDA Rolls out New Market Pathway for Breakthrough Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • The US FDA is launching a new expedited registration route for breakthrough and innovative medical devices.
  • The Breakthrough Devices Program covers qualifying 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE) and de novo applications.
  • The program entails earlier interactions between regulators and manufacturers during product development.
Read more about US FDA Rolls out New Market Pathway for Breakthrough Medical Devices ...

ANVISA Provides More Details on New Brazilian GMP Inspection Regime

EMERGO SUMMARY OF KEY POINTS:

  • Brazil’s ANVISA has published a new regulation to clarify changes to its Brazil GMP inspection and certification process.
  • The regulation, RDC 183/2017, explains which documents are required for BGMP certification as well as which types of establishments that must obtain BGMP certification in Brazil.
  • Applicants that submitted inspection requests before the new BGMP certification process was announced will have 60 days to file amendments to ANVISA to qualify for the new approach.
Read more about ANVISA Provides More Details on New Brazilian GMP Inspection Regime...

New European Notified Body Product Codes Open for Consultation

EMERGO SUMMARY OF KEY POINTS:

  • The first implementing act related to the Regulations for Medical Devices and IVDs is now open for consultation.
  • The significantly changed list of product codes for IVDs is heavily discussed and it is not certain this list will be the final version.
  • The high level of granularity in these tables may complicate audits.
Read more about New European Notified Body Product Codes Open for Consultation...

Health Canada Proposing Major Fee Increases for Medical Device License Applications

EMERGO SUMMARY OF KEY POINTS:

  • Health Canada wants to implement Medical Device License application fee increases for Class II, III and IV medical device registrants.
  • MDL fees have not been significantly adjusted since 2011, according to Health Canada.
  • If implemented, these major MDL fee increases could complicate Canadian market entry for many medical device companies.
Read more about Health Canada Proposing Major Fee Increases for Medical Device License Applications...

Medical Device Cybersecurity Legislation Advances in US Congress

EMERGO SUMMARY OF KEY POINTS:

  • New legislation introduced in the US House of Representatives would launch a working group headed by the FDA to develop strategies for mitigating cybersecurity risks in medical technology.
  • The proposed legislation builds on recommendations issued by the Health Care Industry Cybersecurity Task Force earlier in 2017.
  • If passed by the full Congress, the legislation would require the FDA-led working group to report on its efforts within 18 months.
Read more about Medical Device Cybersecurity Legislation Advances in US Congress...

ANVISA Officially Publishes Brazilian GMP Certification Process Changes

EMERGO SUMMARY OF KEY POINTS:

  • Brazil’s ANVISA has published updated BGMP certification rules allowing for desktop reviews instead of on-site inspections.
  • The new BGMP requirements apply to Class III and IV device registrants able to provide adequate technical documentation for review.
  • A Normative Instruction from ANVISA is anticipated that will provide additional details on how the new BGMP certification process will work.
Read more about ANVISA Officially Publishes Brazilian GMP Certification Process Changes...

Saudi Regulators Confirm New Regulations for Some Low-risk Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • The Saudi Food and Drug Authority (SFDA) has officially announced a new market pathway for Class I non-sterile, non-measuring devices that does not require Medical Device Marketing Authorization (MDMA).
  • Qualifying low-risk device manufacturers may list their products in the Saudi Medical Device National Registry (MDNR) in lieu of MDMA premarket review.
  • Implementation timeframes for the new non-MDMA market pathway have not yet been disclosed.
Read more about Saudi Regulators Confirm New Regulations for Some Low-risk Medical Devices...

Read by 50,000+ device professionals worldwide.

Stay updated on changes to global medical device regulations.RADAR