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Global Medical Device News

Europe's Eudamed Database: Five Key Questions (Part 2)
Europe | Medical Devices

Europe's Eudamed Database: Five Key Questions (Part 2)

In Part Two of Emergo’s series identifying five major questions regarding Eudamed compliance under Europe’s Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR), we cover issues including roles and responsibilities of importers, distributors and Authorized Representatives, plus clinical and performance study issues.

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Source | Ronald Boumans
Aug 8, 2018
Malaysian Regulator Push Back Medical Device Labeling Requirements Emergo
Malaysia | Medical Devices

Malaysian Regulators Push Back Medical Device Labeling Requirement Deadline

EMERGO SUMMARY OF KEY POINTS:

  • The Malaysian MDA is extending medical device labeling compliance deadlines by three years.
  • The extended transition period is intended to allow Malaysian market registrants enough time to ensure compliance.

The Malaysian Medical Device Authority (MDA) is adding a three-year transition...

Source | Stewart Eisenhart
Aug 8, 2018
US FDA Updates Small Business Qualifications Ahead of 2019 Medical Device User Fee Schedule Emergo
United States | Medical Devices

US FDA Updates Small Business Qualifications Ahead of 2019 Medical Device User Fee Schedule

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has updated guidance for small-business certification in order to qualify for reduced medical device user fees for the 2019 fiscal year.
  • A company must have no more than $100 million in sales for its most recent tax year in order to qualify for the FDA’s small-business designation.

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Source | Stewart Eisenhart
Aug 8, 2018
Additional Updates to Saudi Arabian Clearance Policy for Medical Device Shipments Emergo
Saudi Arabia | Medical Devices

Additional Updates to Saudi Arabian Clearance Policy for Medical Device Shipments

EMERGO SUMMARY OF KEY POINTS:

  • The Saudi Food and Drug Administration (SFDA) has issued another update to its clearance policy for medical device shipments to the country.
  • The updates cover shelf-life requirements, last revised earlier in 2018.

The Saudi Food and Drug Authority (SFDA) has published an update to its requirements for clearance...

Source | Stewart Eisenhart
Aug 8, 2018
US FDA Medical Device User Fees Tick Up Slightly for 2019 Emergo
United States | In-Vitro Diagnostic Devices, Medical Devices

US FDA Medical Device User Fees Tick Up Slightly for 2019

EMERGO SUMMARY OF KEY POINTS:

  • US FDA medical device user fees will increase by about four percent for the agency’s 2019 fiscal year.
  • Revised user fees take effect starting October 1, 2018.
  • The latest FDA user fee increases are much less substantial than those put in place last year.

US Food and Drug...

Source | Stewart Eisenhart
Aug 8, 2018
Special Report: Brazil’s ANVISA Improves Medical Device Registration Review Timeframes for 2018 Emergo
Brazil | In-Vitro Diagnostic Devices, Medical Devices

Special Report: Brazil’s ANVISA Improves Medical Device Registration Review Timeframes for 2018

EMERGO SUMMARY OF KEY POINTS:

  • Brazil’s ANVISA reports higher volumes of medical device market application submissions for the first half of 2018.
  • Increased submission volumes are mostly for lower-risk medical devices and IVDs.
  • ANVISA was able to respond to most cadastro and registro market applicants within a 90-day time frame, according to the six-month results.

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Source | Stewart Eisenhart
Aug 8, 2018
Europe’s Eudamed Database: Five Key Questions (Part 1) Emergo
Europe | In-Vitro Diagnostic Devices, Medical Devices

Europe’s Eudamed Database: Five Key Questions (Part 1)

Compliance with Eudamed database requirements under the European Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR) may be years away, but preparation for the new requirements will take sustained effort. We've identified key issues many manufacturers are dealing with ahead of Eudamed's launch.

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Source | Ronald Boumans
Aug 5, 2018
Worldwide | Medical Devices

July 2018 Global Medical Device Regulatory Trends: Traceability, Simplified Market Access

In the past half year (January through June 2018), Emergo has observed data to support two global trends: Initiatives to enhance device tracking and traceability, and simplification of the regulatory process for the lowest-risk medical devices.

Periodically, we review all the global regulatory updates and changes for global trends. These are Emergo’s observations, fueled only by review of regulatory current events (and perhaps a few large cups of coffee). And, our analysis and assessment of them. We should also acknowledge that the International Medical Device...

Source | Evangeline Loh
Jul 24, 2018
China | Medical Devices

China FDA Adds to List of Medical Devices, IVDs Exempt from Clinical Trials

EMERGO SUMMARY OF KEY POINTS:

  • Chinese regulators have added additional Class II and III medical devices as well as some Class III IVD devices to their list of products exempted from clinical trial requirements.
  • Devices in the latest batch of exemptions include lancets, anesthesia needles and incubators.

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Source | Teemo Chang and Stewart Eisenhart
Jul 24, 2018
Saudi Arabia | Medical Devices

Final Guidance on Saudi Arabia’s Medical Device National Registry (MDNR) Route Published

EMERGO SUMMARY OF KEY POINTS:

  • The Saudi Food and Drug Authority (SFDA) has issued final guidance on its Medical Device National Registry (MDNR) market pathway for low-risk devices.
  • The final guidance includes additions and clarifications to MDNR flowchart and declaration of conformity requirements.
  • MDNR listing requirements for Class I non-sterile, non-measuring devices will go into effect in September 2018.

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Source | Stewart Eisenhart
Jul 23, 2018