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Global Medical Device News

United Kingdom | In-Vitro Diagnostic Devices, Medical Devices

Draft Brexit Agreement’s Implications for Medical Device Sector

EMERGO SUMMARY OF KEY POINTS:

  • A draft agreement on Brexit has been struck between EU and UK negotiators.
  • Notified Bodies will remain recognized during the transition period.
  • It is not certain this agreement will be accepted; a cliff-edge Brexit remains a possibility.

British and European negotiators have reached a draft agreement concerning the withdrawal of the United Kingdom from the European Union (EU).

Effects for validity of CE Mark certifications and Notified Bodies

The 585-page...

Source | Ronald Boumans
Nov 16, 2018
Malaysia | Medical Devices

In Brief: Malaysian Regulators Launch New Medical Device Databases

EMERGO SUMMARY OF KEY POINTS:

  • The Malaysian MDA has launched two databases to provide information on medical device registrations and licensed establishments
  • MDA’s database for device registrations is publicly accessible, while its database for licensed establishments is intended only for Malaysia Authorized Representatives, distributors and importers.

The Malaysian Medical Device Authority (MDA) has rolled out two new databases for medical device registration information.

The first database, the...

Source | Stewart Eisenhart
Nov 14, 2018
Australia | Medical Devices

Australian TGA Regulatory Changes for Implantable Medical Devices Starting in December 2018

EMERGO SUMMARY OF KEY POINTS:

  • Australian regulators will begin requiring some implantable medical device manufacturers to provide additional product information to patients starting in December 2018.
  • The Therapeutic Goods Administration (TGA) will also require up-classification of surgical mesh devices to Class III starting in December.
  • These changes will align TGA device registration requirements more closely to the European Medical Devices Regulation (MDR).

The Australian government is set to begin requiring new market registrants of...

Source | Stewart Eisenhart
Nov 13, 2018
Europe | In-Vitro Diagnostic Devices, Medical Devices

European Commission’s Latest Updates to Borderline & Classification Manual

EMERGO SUMMARY OF KEY POINTS:

  • Second update IN 2018 of the Manual on Borderline and Classification.
  • Five new cases added, providing useful illustrations of how the definition of a medical device and the classification rules should be understood.
  • For the MDR there could be some significant differences.

On October 30, 2018 the European Commission published the most recent version of the Borderline & Classification Manual. This document provides guidance on establishing the status of medical devices and IVDs, as well as their risk...

Source | Ronald Boumans
Nov 12, 2018
China | Medical Devices

Chinese Regulators Revamp Innovative Medical Device Review Process

EMERGO SUMMARY OF KEY POINTS:

  • The Chinese National Medical Products Administration (NMPA) has published revised requirements for its innovative medical device review program.
  • NMPA updates to the innovative device registration program take effect December 1, 2018.

The National Medical Products Administration (NMPA), China’s medical device market regulator, has developed new procedures taking effect December 1, 2018 for premarket reviews of innovative devices.

The new NMPA policy,...

Source | Stewart Eisenhart
Nov 8, 2018
United States | Medical Devices

US FDA Updates UDI Policy for Direct Marking of Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has revised UDI direct marking requirements and deadlines for some non-sterile, Class I and unclassified medical devices.
  • UDI policy changes were prompted to assist manufacturers manage compliance for devices in inventory and avoid potential device shortages.

The US Food and Drug Administration has revised its Unique Device Identification (UDI) regulation’s direct mark requirements and compliance deadlines in response to cost and inventory concerns raised by industry.

In new, immediately effective...

Source | Stewart Eisenhart
Nov 8, 2018
Europe | In-Vitro Diagnostic Devices, Medical Devices

MDR and IVDR Implementation: Update from the European Commission

EMERGO SUMMARY OF KEY POINTS:

  • MDR and IVDR implementations still on track as planned.
  • The first Notified Bodies to be designated may be announced by the end of 2018.
  • Eudamed is advancing as planned.
  • Brexit is a matter of concern, but all UK based Notified Bodies appear to be taking appropriate actions.

The European Commission reports that implementation efforts for the EU Medical Devices Regulation (MDR) 2017/45 and In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 remain on track, as well as related efforts...

Source | Ronald Boumans
Nov 5, 2018
United States | Medical Devices

US FDA Adds Details for Medical Device Conformity Assessment Accreditation Program Pilot

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has provided more information on its upcoming Accreditation Scheme for Conformity Assessment (ASCA) pilot program.
  • ASCA will include at least five FDA-recognized voluntary consensus standards for medical devices.
  • The pilot is expected to launch by September 2020.

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has published additional information on its pilot program for medical device conformity assessment accreditation, known as the Accreditation Scheme for...

Source | Stewart Eisenhart
Oct 31, 2018
Saudi Arabia | Medical Devices

Saudi Regulators Adjust Timeframes for Medical Device Market Application (MDMA) Submissions

EMERGO SUMMARY OF KEY POINTS:

  • The Saudi Food and Drug Authority (SFDA) has announced updates to certain timeframes for Medical Device Market Application (MDMA) submissions.
  • Revised MDMA deadlines pertain to registration payments and responses to SFDA requests for additional information.

Medical device regulators at the Saudi Food and Drug Authority (SFDA) have updated deadlines for pending Medical Device Market Application (MDMA) submissions.

According to Emergo by UL sources in Riyadh, new MDMA timeframes for manufacturers and their in-...

Source | Stewart Eisenhart
Oct 30, 2018
Brazil | In-Vitro Diagnostic Devices, Medical Devices

Brazil’s ANVISA Reports Increase in Medical Device Modification Submissions

EMERGO SUMMARY OF KEY POINTS:

  • Brazil’s ANVISA reports progress in meeting review timeframes for medical device and IVD reviews between July and September 2018.
  • ANVISA also reports a spike in modification applications following changes to Brazilian importing and inspection requirements for medical devices and IVDs.
  • Rejection rates for cadastro, registro and IVD submissions over the past three months remain in line with yearlong trends reported by ANVISA.

Brazilian medical device market regulator ANVISA has reported a major increase in...

Source | Stewart Eisenhart
Oct 29, 2018