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.

South Korean MFDS Revises Recently Enacted Medical Device Regulations

EMERGO SUMMARY OF KEY POINTS:

  • The South Korean MFDS has updated medical device regulations covering premarket reviews, registrations and enforcement.
  • MFDS is also seeking industry comment on a draft proposal updating medical device safety and adverse event reporting requirements.
Read more about South Korean MFDS Revises Recently Enacted Medical Device Regulations...

Russian Regulators Amending Medical Device, IVD Registration Requirements

EMERGO SUMMARY OF KEY POINTS:

  • Russian regulatory changes for medical device and IVD registrants are slated to take effect by late 2017.
  • Roszdravnadzor (RZN) has proposed easing requirements for IVD registrations as well as certain changes to medical device registrations.
  • Medical device registration changes pertaining to technical documentation and user’s manuals, however, would require additional RZN review under the proposed changes.  
Read more about Russian Regulators Amending Medical Device, IVD Registration Requirements...

US FDA Launching New Premarket Approval (PMA) Pilot Program for High-risk Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • The US FDA is setting up a pilot program to make its Premarket Approval (PMA) review process for high-risk medical devices more efficient.
  • The agency is seeking nine PMA applicants for participation in the program.
  • The agency will consider PMA applicants for participation in the program starting in late September 2017.
Read more about US FDA Launching New Premarket Approval (PMA) Pilot Program for High-risk Medical Devices...

Singapore HSA Clarifies Telehealth and Mobile Medical App Guidelines

EMERGO SUMMARY OF KEY POINTS:

  • The Singapore Health Sciences Authority (HSA) has issued new clarification and an FAQ regarding how telehealth products and mobile medical apps are regulated in the country.
  • HSA plans an immediate market access pathway for mobile medical apps that have already registered in the US, Canada, Australia, Europe and/or Japan.
  • Singapore’s general regulatory approach to telehealth resembles that of the US FDA.
Read more about Singapore HSA Clarifies Telehealth and Mobile Medical App Guidelines...

New FDA De Novo User Fees: Effects for cutting-edge medical device manufacturers

EMERGO SUMMARY OF KEY POINTS:

  • New FDA user fees for de novo medical device registrations may impact some manufacturers’ plans for commercialization of novel and cutting-edge products in the US.
  • Even small-business FDA user fees for de novo applications may prove too high for some prospective US medical device market registrants.
Read more about New FDA De Novo User Fees: Effects for cutting-edge medical device manufacturers...

New CFDA Medical Device Classification Catalog May Require New Registrations in China

EMERGO SUMMARY OF KEY POINTS:

  • A new China FDA classification catalog may require new registrations for some medical device market applicants.
  • Changes in classification requirements in the new catalog may result in up-classification (and re-registration) of some Class I medical devices in China.
  • The new classification catalog will be implemented on August 1, 2018.
Read more about New CFDA Medical Device Classification Catalog May Require New Registrations in China...

UK Regulator Launches Interactive Guide to New European Medical Device, IVD Regulations

EMERGO SUMMARY OF KEY POINTS:

  • A new interactive online guide from the UK MHRA provides high-level overviews of new European medical device and IVD regulations.
  • The new guide should prove useful for CE Mark certificate holders has they prepare for full compliance with the Medical Devices Regulation (MDR 2017/745) and In-Vitro Diagnostic Regulation (IVDR 2017/746).
Read more about UK Regulator Launches Interactive Guide to New European Medical Device, IVD Regulations...

How to Qualify for 2018 FDA Small-Business Medical Device User Fees

EMERGO SUMMARY OF KEY POINTS:

  • The US FDA has published new guidance explaining how companies should apply to qualify for small-business medical device user fees instead of much higher standard fees.
  • Generally, companies must have no more than $100 million in sales to qualify for the FDA’s small business user fee program.
  • The guidance includes separate requirements for US-based and foreign medical device market applicants.
Read more about How to Qualify for 2018 FDA Small-Business Medical Device User Fees ...

MDUFA IV: Most US FDA user fees for medical device companies jump 33% or more in 2018

EMERGO SUMMARY OF KEY POINTS:

  • FDA user fees for the 2018 fiscal year have increased across all registration categories.
  • 510(k) fee paid by companies that don't qualify for small business discount will more than double.
  • Annual Establishment Registration fee increasing 37% with no discount for small businesses.
Read more about MDUFA IV: Most US FDA user fees for medical device companies jump 33% or more in 2018...

In Brief: US FDA, Brazil ANVISA Expand Lists of Qualified Audit Organizations for MDSAP

EMERGO SUMMARY OF KEY POINTS:

  • US and Brazilian medical device market regulators have updated their lists of organizations authorized to conduct QMS audits under the Medical Device Single Audit Program (MDSAP).
  • There are now four companies recognized as MDSAP auditing organizations and 13 organizations authorized by the US FDA to carry out audits.
  • Brazil’s ANVISA now recognizes nine MDSAP audit organizations.
Read more about In Brief: US FDA, Brazil ANVISA Expand Lists of Qualified Audit Organizations for MDSAP...

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