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.

Malaysian Authorities Publish Medical Device Registration Transfer Policy

EMERGO SUMMARY OF KEY POINTS:

  • The Malaysian MDA has put out new guidance for medical device registration transfers.
  • Registration transfers are only available for devices that have already obtained market authorization from the MDA.
  • Malaysian device registration transfers require cooperation between current and new authorized representatives.

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Transition to the new European Medical Device Regulations: Risks for the continuity of care

EMERGO SUMMARY OF KEY POINTS:

  • Medical device CE Mark recertification challenges may impact near-term supplies of those devices in the European Union.
  • European regulators have agreed to stop-gap measures for device manufacturers whose Notified Bodies stop operating in the market.
  • Addressing Europe’s “orphaned device” challenge will require efforts from Competent Authorities, manufacturers and healthcare providers.

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Japanese Regulators to Reduce Some QMS Assessment Fees 30% in 2017

EMERGO SUMMARY OF KEY POINTS:

  • Japanese QMS conformity assessment fees for Class II medical devices will be reduced by 30%.
  • The fee reductions take effect in April 2017.

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Updates on South Korean Medical Device Regulatory Changes

EMERGO SUMMARY OF KEY POINTS:

  • Several South Korean medical device and IVD regulatory changes have taken effect in late December 2016 and early January 2017.
  • These regulatory changes affect issues including IVD documentation requirements, medical device advertisements and MDITAC review processes.
  • Premarket review fee increases have not yet been finalized by the Ministry of Food and Drug Safety, but are expected to take effect in 2017.

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Swiss Competent Authority Weighs in on Medical Device Firms “Orphaned” by their Notified Bodies

EMERGO SUMMARY OF KEY POINTS:

  • Switzerland’s Competent Authority has established grace periods for Swiss device manufacturers that must find new Notified Bodies to renew CE Mark certification.
  • Swissmedic’s process resembles that announced by French Competent Authority ANSM in late 2016 for affected French manufacturers.
  • To qualify for Swissmedic’s program, affected manufacturers must have already initiated certification renewal efforts with new Notified Body partners.

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Final US FDA Guidance on Post-market Cybersecurity Risk Management

EMERGO SUMMARY OF KEY POINTS:

  • The US FDA has issued final guidance regarding post-market cybersecurity risk management for medical devices.
  • The final guidance comes about a year after the FDA published draft guidance on managing medical device cybersecurity risks.

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Top 10 Medical Device Regulatory Stories of 2016

At the start of a new year, Emergo takes a look back at what we believe were some of the most important developments of 2016 for the medical device regulatory field worldwide.

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US FDA Finalizes Rule for Post-market Combination Product Safety Reporting

EMERGO SUMMARY OF KEY POINTS:

  • A new US FDA final rule addresses post-market safety reporting obligations for combination products.
  • Reporting requirements for combination products are determined by regulations that apply to their component drug, device and/or biological components.
  • A combination product’s component or constituent parts manufacturers must share post-market safety reporting data with each other, according to the new rule.

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US FDA Explains Approach to Medical Device Post-Market “Emerging Signals”

EMERGO SUMMARY OF KEY POINTS

  • Final FDA guidance explains how the agency notifies the public of potential links between registered medical devices and adverse events.
  • Factors including probability and magnitude of harmful events, quality of post-market data and availability of alternative treatments impact whether the FDA issues “emerging signal” notifications.

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European Commission: Entry into force of MDR, IVDR Anticipated for Late May 2017

EMERGO SUMMARY OF KEY POINTS:

  • New European regulations for medical devices and IVDs will enter into power in May 2017.
  • Full implementation deadlines for the MDR and IVDR now appear set for May 2020 and May 2022, respectively.
  • So far, parties discussing translation of the Regulations into English have been able to avoid having to reopen formal negotiations.

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