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 ANVISA Clarifies Local, Federal Level Medical Device Oversight Responsibilities

EMERGO SUMMARY OF KEY POINTS:

  • ANVISA has formally mapped out medical device regulatory responsibilities at its federal, state-level and local branches.
  • Under RDC 215/2018, ANVISA oversight responsibilities and structures currently in place are mostly kept as is.
Read more about Brazilian ANVISA Clarifies Local, Federal Level Medical Device Oversight Responsibilities ...

Emergo Survey: Regulatory Challenges Having Bigger Impact on Smaller Medical Device Companies

EMERGO SUMMARY OF KEY POINTS:

  • Regulatory challenges are affecting larger percentages of both large and small medical device companies heading into 2018, according to a new Emergo survey.
  • In previous years, small and startup companies were more concerned with funding and capital issues than regulatory challenges.
  • Product development, pricing pressure and funding challenges also ranked highly in our 2018 survey.
Read more about Emergo Survey: Regulatory Challenges Having Bigger Impact on Smaller Medical Device Companies ...

UDI for Medical Devices Going Global

EMERGO SUMMARY OF KEY POINTS:

  • Most markets all over the world will have a system for Unique Device Identification within five years.
  • It will likely be possible to have a single code on each device for all these markets.
  • It is likely that those codes will be linked to different databases for each market.
  • In March 2018 the European Commission will publish a guidance document on UDI under the MDR and IVDR.
Read more about UDI for Medical Devices Going Global...

Chinese Regulators Issue Near-Term Plan for Medical Device Standards Development

EMERGO SUMMARY OF KEY POINTS:

  • Chinese regulators plan to develop new medical device standards over a two-year period.
  • The standards will cover risk management, quality and clinical trials, and align with international standards, according to CFDA.
  • CFDA will also hire up to 200 additional staff to support standards development.
Read more about Chinese Regulators Issue Near-Term Plan for Medical Device Standards Development ...

China FDA Two-track Medical Device Testing Policy May be Coming

EMERGO SUMMARY OF KEY POINTS:

  • The China Food and Drug Administration (CFDA) may soon launch a two-track in-country testing pathway for medical devices.
  • A possible commission testing option would cost registrants a fee but allow a potentially faster testing process.
  • No official CFDA rollout of the new testing policy has occurred yet.
Read more about China FDA Two-track Medical Device Testing Policy May be Coming...

8 Key Steps to Delivering Effective, In-person Medical Device Training

For some medical devices used in clinical and home environments, end-users are the benefactors of formal training designed to facilitate safe and effective device use. However, not all medical device training programs are created equal.

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FDA Updates PMA and 510(k) Refuse to Accept Policy for Combination Products

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has updated its 510(k) Refuse to Accept and Premarket Approval acceptance policies for combination product submissions.
  • The updated guidances include new requirements for drug patent and exclusivity information.
Read more about FDA Updates PMA and 510(k) Refuse to Accept Policy for Combination Products...

In Brief: US Legislators Put Medical Device Tax Back on Ice

US lawmakers have delayed reestablishing the Medical Device Excise Tax (MDET) by another two years as part of a short-term government funding arrangement.

Read more about In Brief: US Legislators Put Medical Device Tax Back on Ice...

New Training Course on UL Medical Device Cybersecurity Standard Set for April 2018

UL’s Health Science Digital Health division will conduct a two-day training course on the company’s cybersecurity standard for medical devices in April 2018 in Denmark.

Read more about New Training Course on UL Medical Device Cybersecurity Standard Set for April 2018...

Brazil’s ANVISA Doubles Validity Timeframes for High-Risk Medical Devices and IVDs

EMERGO SUMMARY OF KEY POINTS:

  • ANVISA has extended Class III and IV medical device and IVD registration validity times from five to 10 years.
  • These changes have already gone into effect in Brazil.
  • ANVISA registrants that have already obtained registration renewals will automatically qualify for the extended validity timeframe.
Read more about Brazil’s ANVISA Doubles Validity Timeframes for High-Risk Medical Devices and IVDs...

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