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.

Australian Regulators Plan Improved Patient Access, Reimbursement for Prosthetic Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • Australian regulators to publish Prostheses List three times per year starting in 2019
  • Private insurers as well as prosthetic device manufacturers active in Australia will be impacted
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China FDA Eases Country-of-Origin Requirements for Hong Kong-based Medical Device Registrants

The China Food and Drug Administration (CFDA) has begun recognizing certain certifications issued by the Hong Kong Medical Device Control Office (MDCO) for country-of-origin requirements.

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In Brief: Swiss Regulators Moving to Online Medical Device Certification

Swissmedic, Switzerland’s medical device market regulator, will replace its current processes for issuing export certificates as well as manufacturing certificates with an online system in order to prevent delays and free up resources.

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Dutch Ministry of Health: Prepare for a "Cliff Edge Brexit"

EMERGO SUMMARY OF KEY POINTS:

  • After Brexit there will be a border, with the UK outside the EU.
  • Customs Union or EEA options are unlikely outcomes.
  • Prepare for a hard Brexit (‘Cliff Edge Brexit’) on 29 March 2019.
  • A hard Brexit will likely impact all organizations, even if you do not interact with the UK.
  • Disclaimer: This blog only gives a limited update on the current situation. We can only speculate as to what the final outcome will be.
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Balancing Aesthetics and Usability in Medical User Interface Design: 9 Key Trends

As the influence of technology in our everyday lives continues to grow, the standard for aesthetically pleasing and contemporary user interface (UI) designs in the healthcare space continues to evolve.

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Changes to Chinese Medical Device Regulations would Benefit Foreign Manufacturers

EMERGO SUMMARY OF KEY POINTS:

  • Chinese regulators have drafted changes to Order No. 650 covering various medical device regulatory requirements.
  • Proposed changes would affect product test reports, clinical evaluation report (CER) requirements, importing of innovative devices, and more.
  • The Chinese government has not yet announced firm implementation timeframes for these changes.
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New South Korean Guidelines for Medical Device Cybersecurity Management

EMERGO SUMMARY OF KEY POINTS:

  • South Korea’s Ministry of Science and ICT has published new guidelines for medical device cybersecurity risk management.
  • The guidelines reference UL 2900, US FDA cybersecurity guidance and related standards and recommendations in place in other medical device markets.
Read more about New South Korean Guidelines for Medical Device Cybersecurity Management...

India Officially Proposes Expansion of Regulatory Oversight to More Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • Indian regulator CDSCO to formalize proposals to expand registration requirements to more types of medical devices.
  • Affected manufacturers will have one year following publication of new requirements in the Gazette of India to comply.
  • Types of devices to fall under CDSCO oversight include implantable devices, CT and MRI equipment and dialysis systems.
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Brazilian Regulators Introduce UDI Requirements for Some High-risk Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • Brazilian regulators are introducing UDI requirements for high-risk devices including stents and implants.
  • ANVISA’s new RDC 232/2018 brings UDI to the Brazilian market for the first time.
  • Implementation of the regulation as well as a UDI database, the RNI System, is expected in 2020.
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ANSI UL Medical Device Cybersecurity Standard Receives Official US FDA Recognition

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has officially recognized a new consensus standard, ANSI UL 2900-2-1, for assessing network-connected medical device cybersecurity risk.
  • US medical device market applicants may now utilize ANSI UL 2900-2-1 to demonstrate safety of their network-connected devices, accessories and software.
  • FDA recognized a related standard, UL 2900-1 Ed. 2017, last year.
Read more about ANSI UL Medical Device Cybersecurity Standard Receives Official US FDA Recognition...

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