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.

Brazilian Regulators Establish Criteria for Marketing of Unregistered Medical Devices

EMERGO KEY POINTS:

  • New Brazilian regulations list criteria for importing unregistered medical devices and health products into the country to address public health issues.
  • Qualifying devices and products must be requested by the Brazilian Ministry of Health; requests are then reviewed by ANVISA.
Read more about Brazilian Regulators Establish Criteria for Marketing of Unregistered Medical Devices...

Malaysian Regulators Extend Moratorium for Medical Device Registrations

EMERGO SUMMARY OF KEY POINTS:

  • The Malaysian MDA will allow qualifying medical device market applicants to sell their products in the country pending full regulatory approval through June 2018.
  • MDA registrants that submitted applications on or before June 30, 2016 qualify for the extended moratorium.
  • Companies that submitted MDA registration applications after June 30, 2016 must obtain full regulatory approval before Malaysian commercialization.
Read more about Malaysian Regulators Extend Moratorium for Medical Device Registrations ...

It’s Back: Following Moratorium, US Medical Device Excise Tax (MDET) Returns in 2018

EMERGO SUMMARY OF KEY POINTS:

  • The US Medical Device Excise Tax (MDET) will come back into effect in 2018.
  • Manufacturers and importers of taxable medical devices will be subject to a 2.3% tax on US sales.
  • Years-long MDET repeal efforts by industry and Congressional allies have so far not succeeded.
Read more about It’s Back: Following Moratorium, US Medical Device Excise Tax (MDET) Returns in 2018...

US Regulators Refine Least Burdensome Provisions for Medical Device Oversight

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has updated guidance on how least burdensome provisions are applied to medical device registration and oversight.
  • The new guidance applies across all aspects of FDA medical device regulation.
  • The FDA’s least burdensome approach may lead to less onerous US market authorization requirements for some manufacturers.
Read more about US Regulators Refine Least Burdensome Provisions for Medical Device Oversight...

European Internet of Things Cybersecurity Recommendations: Impact for Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • European regulators have published high-level cybersecurity recommendations for industries including medical devices involved in the Internet of Things (IoT) paradigm.
  • The recommendations are partially intended to help companies meet upcoming European data privacy requirements under the General Data Protection Regulation, or GDPR.
  • The European report cites US FDA guidance regarding medical device cybersecurity principles and recommendations.
Read more about European Internet of Things Cybersecurity Recommendations: Impact for Medical Devices...

Final Guidance from US FDA on Clinical Evaluation of Software as a Medical Device (SaMD)

EMERGO SUMMARY OF KEY POINTS:

  • US FDA final guidance on clinical evaluation of software as a medical device (SaMD) is now published.
  • The guidance utilizes SaMD clinical evaluation principles and recommendations issued by the International Medical Device Regulators Forum (IMDRF).
  • US regulators intend to use this guidance as a basis for developing more specific SaMD clinical evaluation guidance in the future.
Read more about Final Guidance from US FDA on Clinical Evaluation of Software as a Medical Device (SaMD)...

US Regulators Lay Out Medical Device, IVD Guidance Priorities for 2018

EMERGO SUMMARY OF KEY POINTS:

  • The US FDA’s Center for Devices and Radiological Health (CDRH) unit has publicized plans for medical device and IVD guidances over the next year.
  • High-priority areas of focus for CDRH in 2018 include 510(k) third-party reviews and abbreviated pathways, Unique Device Identification (UDI) deadlines for low-risk devices and device accessory classification.
  • Not all planned CDRH guidance documents will be published due to resource allocation and other regulatory obligations.
Read more about US Regulators Lay Out Medical Device, IVD Guidance Priorities for 2018...

US FDA Rolls Out Trio of Digital Health and Medical Software Guidances

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has issued three new guidances focused on digital health technology regulations.
  • The guidances stem from 21st Century Cures Act requirements for timelier registration processes for digital medical technologies.
Read more about US FDA Rolls Out Trio of Digital Health and Medical Software Guidances...

Designing Effective Warnings for Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • Medical device warnings require careful design and communication considerations.
  • Manufacturers should heed warning sign conventions such as signal words.
  • Warnings are not foolproof, but are a necessary component for medical device risk mitigation.

Some people believe that warnings are useless; printed on medical devices only to offer legal protection. Indeed, manufacturers can and have been held liable for the “failure to warn,” and adding warnings neutralizes this claim.

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In Brief: New China FDA Guidance on Medical Device Registration Grouping

EMERGO SUMMARY OF KEY POINTS:

  • Final guidance from China Food and Drug Administration (CFDA) on medical device registration grouping criteria
  • First CFDA update on registration grouping guidance since March 2015
Read more about In Brief: New China FDA Guidance on Medical Device Registration Grouping...

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