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Global Medical Device News

Australia | Medical Devices

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

EMERGO SUMMARY OF KEY POINTS:

  • Australian Department of Health (DoH) to publish Prostheses List three times per year starting in 2019
  • Private insurers as well as prosthetic device manufacturers and active in Australia as well as their distributors will be impacted

The Australian Department of Health (DoH) will begin publishing its Prostheses List of prosthetic medical devices more frequently starting in 2019 in an effort to address patient access to new devices and respond to manufacturers' concerns regarding reimbursement delays....

Source | Stewart Eisenhart
Jul 17, 2018
Hong Kong | Medical Devices

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.

According to the ...

Source | Stewart Eisenhart
Jul 15, 2018
Europe | Medical Devices

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.

Swissmedic will launch the new system September 17, 2018, and has set a deadline of October 18, 2018 for transitioning from the current certification system. The change affects Swiss medical...

Source | Stewart Eisenhart
Jul 11, 2018
Europe | Medical Devices

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.

...

Source | Ronald Boumans
Jul 9, 2018
Worldwide | Medical Devices

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.

From flat design to material design, and gestural controls to long form content scrolling, healthcare professionals’ and patients’ expectations for what a medical device should look and behave like are influenced by the UI trends seen in consumer products.

Unfortunately, many of the contemporary UI trends in the consumer space do not translate well to safety...

Source | Valerie Ng and Jon Tilliss
Jul 8, 2018
China | Medical Devices

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.

...

Source | Teemo Chang and Stewart Eisenhart
Jul 5, 2018
South Korea | Digital Health Products

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.

...

Source | Stewart Eisenhart
Jul 2, 2018
South Korea | Medical Devices

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.

...

Source | Stewart Eisenhart
Jul 1, 2018
India |

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.

...

Source | Stewart Eisenhart
Jun 27, 2018
Brazil |

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.

...

Source | Stewart Eisenhart
Jun 27, 2018