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.

China FDA Reorganization: Impact for medical device registrants

EMERGO SUMMARY OF KEY POINTS:

  • The China Food and Drug Administration (CFDA) is being reorganized into the China Drug Administration (CDA).
  • A new State Administration for Market Supervision take over management of CDA from the Chinese State Council.
  • Emergo consultants are still determining whether and how the Chinese regulatory reorganization will affect medical device registrants.
Read more about China FDA Reorganization: Impact for medical device registrants...

India’s CDSCO Plans to Regulate Additional Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • Indian regulators intend to expand oversight to additional types of medical devices.
  • The Indian CDSCO has identified ultrasound and related imaging equipment as additions to its List of Notified Medical Devices.
  • CDSCO has not provided any timeframes for when these products will become regulated devices.
Read more about India’s CDSCO Plans to Regulate Additional Medical Devices...

Changes to Brazil ANATEL Certification Requirements for Wireless Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • ANATEL certification for wireless medical devices is now required for ANVISA registration in Brazil.
  • Previously, ANATEL certification was required for commercialization but not registration.
  • Manufacturers that have already started their ANVISA registration projects will need to secure ANATEL certification before submitting registration applications.
Read more about Changes to Brazil ANATEL Certification Requirements for Wireless Medical Devices...

HFES Conference Workshop on Risk Analyses for Summative Usability Tests

A workshop session at the 2018 International Symposium on Human Factors and Ergonomics in Health Care will provide insights into conducting residual risk analyses for summative usability tests for medical devices.

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FDA Delays Post-market Safety Reporting Requirements for Combination Products

EMERGO SUMMARY OF KEY POINTS:

  • Postponed FDA enforcement of post-market safety reporting rules (PMSR) for combination products
  • Delay allows combination product applicants more time to implement appropriate reporting and recordkeeping systems and procedures
Read more about FDA Delays Post-market Safety Reporting Requirements for Combination Products...

Health Canada Reclassifies Certain Disinfectants as Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • Health Canada will begin regulating some disinfectants and sterilizing solutions including contact lens solution as medical devices.
  • Affected products are now considered Class II devices, but Health Canada intends to eventually reclassify them as Class III devices.
  • Affected manufacturers will have 18 months to obtain Medical Device Licenses (MDL).
Read more about Health Canada Reclassifies Certain Disinfectants as Medical Devices ...

Five Reasons for Receiving an FDA Refuse-to-Accept (RTA) Decision on your 510(k) Registration

EMERGO SUMMARY OF KEY POINTS:

  • FDA 510(k) applicants may receive Refuse to Accept (RTA) letters if their submissions are not complete, delaying their medical device clearance reviews.
  • Meeting RTA screening criteria can help medical device registrants avoid receiving RTA letters from FDA reviewers.
  • Utilizing the FDA Pre-Submission (Pre-Sub) program prior to submitting 510(k) applications may also minimize the risk of clearance delays due to RTA issues.
Read more about Five Reasons for Receiving an FDA Refuse-to-Accept (RTA) Decision on your 510(k) Registration...

New Seminar on Human Factors Engineering for Medical Devices in May 2018

UL’s Human Factors Engineering (HFE) practice will conduct a new seminar on HFE strategies and approaches for medical device manufacturers on May 31, 2018 in Denmark.

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Emergo Survey: Tempered Growth Expectations for Medical Device Markets in 2018

Medical device manufacturers’ growth expectations for markets worldwide have decreased for 2018 compared to previous years due to various regulatory and economic factors, a recent survey shows.

Read more about Emergo Survey: Tempered Growth Expectations for Medical Device Markets in 2018...

AAMI Webinar on HFE Reports for Medical Device Manufacturers

A new webinar hosted by the Association for the Advancement of Medical Instruments (AAMI) will provide insights into preparing Human Factors Engineering (HFE) test plans and reports that existing regulatory guidance does not fully address.

Read more about AAMI Webinar on HFE Reports for Medical Device Manufacturers...

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