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 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...

US FDA Sheds Light on Digital Health Technology Plans

EMERGO SUMMARY OF KEY POINTS:

  • The US FDA has rolled out its Digital Health Innovation Action Plan to facilitate faster market access for mobile medical app and technology developers.
  • A new pilot program, the FDA Pre-Cert for Software, will emphasize digital health developers rather than their devices and technologies.
  • The FDA also plans to add personnel to focus on digital health technology premarket reviews.
Read more about US FDA Sheds Light on Digital Health Technology Plans...

India: Draft Essential Principles for Medical Device Safety and Performance Out for Comment

EMERGO SUMMARY OF KEY POINTS:

  • The Indian CDSCO has published draft Essential Principles for medical device and IVD safety and performance.
  • Indian regulators are seeking industry comment through August 2017 on the proposed Essential Principles.
  • The draft Essential Principles are part of India’s new Medical Device Rules, 2017 slated for early 2018 implementation.
Read more about India: Draft Essential Principles for Medical Device Safety and Performance Out for Comment...

Chinese Regulators Identify First Round of Medical Device Clinical Trial Inspections

EMERGO SUMMARY OF KEY POINTS:

  • Chinese regulators have identified the first 10 medical device clinical trial sites to undergo CFDA inspections.
  • So far, the new CFDA inspection program focuses primarily on clinical trials for domestic registrants.
  • Foreign device registrants may undergo CFDA inspections with more frequency as the program continues.
Read more about Chinese Regulators Identify First Round of Medical Device Clinical Trial Inspections...

FDA Rolls Out New Policy for Accepting Consensus Standards for Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • New FDA process for accepting medical device consensus standards 
  • 60-day timeframe for FDA review and acceptance of new standards
  • What should be included in requests for recognition of standards
Read more about FDA Rolls Out New Policy for Accepting Consensus Standards for Medical Devices...

Australian TGA to Take Over Medical Device Advertising Complaint Oversight in 2018

EMERGO SUMMARY OF KEY POINTS:

  • Australian advertising complaint oversight for medical devices and drugs will be consolidated under the Therapeutic Goods Administration.
  • Full TGA oversight will begin in July 2018.
  • Additional advertising requirement reforms for medical devices are planned for 2018.
Read more about Australian TGA to Take Over Medical Device Advertising Complaint Oversight in 2018...

Emergo survey: Medical device R&D spending expected to rise through 2018

EMERGO SUMMARY OF KEY POINTS:

  • A May 2017 Emergo survey finds that smaller medical device companies (less than 50 employees) are planning more aggressive R&D investments over the next 12 months.
  • Pricing pressures are a larger factor for large firms’ R&D plans, while product development and commercialization are key drivers for small and start-up companies.
  • More than 70% of survey respondents say they will begin R&D efforts for new devices over the next 12 months.
Read more about Emergo survey: Medical device R&D spending expected to rise through 2018...

Chinese Regulators Launching Medical Device Clinical Trial Inspection Program

EMERGO SUMMARY OF KEY POINTS:

  • CFDA inspections of medical device clinical trial sites will begin in the near future.
  • CFDA inspectors will be examining traceability and authenticity of clinical data.
  • Clinical trial sponsors and institutions will be notified prior to on-site inspections.
Read more about Chinese Regulators Launching Medical Device Clinical Trial Inspection Program...

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