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Global Medical Device News

United States | Medical Devices

US FDA Scaling Back 30-Day Grace Period for GUDID Medical Device Data Corrections

EMERGO BY UL SUMMARY OF KEY POINTS:

  • FDA is ending an extended grace period for Global Unique Device Identification Database (GUDID) submission corrections in early 2019.
  • The GUDID grace period will be reduced from 30 calendar days currently to seven days.
  • The grace period allows medical device companies to edit or correct GUDID Device Identifier (DI) records following submission but before availability to the public.

Medical device regulators at the US Food and Drug Administration plans to wind down its temporary 30-day grace period in...

Source | Stewart Eisenhart
Jan 2, 2019
Europe | Medical Devices

Brexit Contingency Action Plan Issued by European Commission

EMERGO BY UL SUMMARY OF KEY POINTS:

  • The European Commission has published its emergency plan for Brexit.
  • The focus of this plan is to safeguard the interests of European citizens and UK citizens currently living in the EU27.
  • Plans are defined on a high level; there is nothing specific on medical devices.

The UK has voted in a referendum to leave the European Union (EU). The procedure, described in article 50 of the Treaty of the European Union, started on March 30, 2017 and should take two years at a maximum. With less than 100 days to...

Source | Ronald Boumans
Dec 20, 2018
United States | Combination Products, Medical Devices

US FDA Finalizes Guidance on Breakthrough Medical Device Pathway

EMERGO BY UL SUMMARY OF KEY POINTS:

  • US FDA has published final guidance on its Breakthrough Medical Device market pathway for novel devices and combination products.
  • The new program incorporates elements of prior FDA programs including the Expedited Access Pathway (EAP) and Priority Review program.
  • Devices that use novel and cutting-edge technologies to address life-threatening or permanently debilitating diseases may qualify for the new program.

The US Food and Drug Administration has finalized details of a new registration route for...

Source | Stewart Eisenhart
Dec 19, 2018
Canada | Digital Health Products

Health Canada Setting Pre-market Medical Device Cybersecurity Requirements

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Health Canada has proposed more formalized cybersecurity requirements for Medical Device License applicants.
  • The Health Canada requirements align with cybersecurity approaches adopted by medical device regulators in the US and other jurisdictions.
  • Health Canada recommends adoption of testing standards such as UL 2900 to support device cybersecurity claims.

New guidance from Health Canada would establish cybersecurity requirements and considerations for pre-market reviews of devices in Canada similar...

Source | Stewart Eisenhart
Dec 18, 2018
India | Medical Devices

India Adds Four Medical Device Types to CDSCO List of Regulated Products

EMERGO BY UL SUMMARY OF KEY POINTS:

  • India’s CDSCO has expanded its list of medical devices to be regulated.
  • CDSCO’s latest round of additions includes blood pressure monitors, digital thermometers and nebulizers.
  • Identified devices will have to comply with India’s Medical Device Rules 2017 starting January 1, 2020.

The Indian government will expand regulatory oversight to four additional types of medical devices starting in January 2020.

According to The Gazette of India and Emergo by UL consultants in , the four device...

Source | Stewart Eisenhart
Dec 13, 2018
Canada | Medical Devices

Canada’s MDSAP Transition Deadline Fast Approaching

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Health Canada’s December 31, 2018 deadline for MDSAP transition imminent.
  • Medical Device License (MDL) holders for Class II, III and IV devices must submit evidence of transition from CMDCAS to MDSAP by the December 31st deadline.

Health Canada has issued a final email reminder to medical device companies regarding the regulator’s December 31, 2018 deadline for transitioning to the Medical Device Single Audit Program (MDSAP) for quality management system compliance.

According to the Health...

Source | Stewart Eisenhart
Dec 7, 2018
Europe | Medical Devices

Brexit Update: New Notified Body Designated in The Netherlands

EMERGO BY UL SUMMARY OF KEY POINTS:

  • The NANDO database has been updated to include the new Notified Body BSI Netherlands.
  • BSI Group The Netherlands is formally designated to carry out conformity assessments according to the MDD, AIMDD and IVDD.
  • BSI Group now has two entities, BSI UK with Notified Body number 0086 and BSI-NL with Notified Body number 2797.

Information updated on December 13, 2018.

Although the first Notified Bodies (NBs) will soon be designated to...

Source | Annette van Raamsdonk
Dec 6, 2018
United States | Medical Devices

US FDA Wants More Formalized Processes for De Novo Medical Device Classification Requests

EMERGO BY UL SUMMARY OF KEY POINTS:

  • US FDA has proposed formal policies and criteria for De Novo novel medical device classification requests.
  • The De Novo classification route allows some low- and moderate-risk devices for which substantial equivalence cannot be established to obtain US market access.
  • The proposed rules would set a 120-day review period for De Novo classification requests.

Medical device regulators at the US Food and Drug Administration have proposed a more formalized and clarifying approach to registration...

Source | Stewart Eisenhart
Dec 5, 2018
Worldwide | Medical Devices

No Shortcuts: Building Out the Right Processes to Ensure Medical Device Safety and Security

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Regulatory focus on medical device safety and risk management intensifying;
  • Functions such as clinical research, post-market surveillance and ISO 14971 compliance should bolster safety and risk management efforts;
  • More robust safety and risk management processes to help medical device companies pivot faster when regulators change requirements.

Ensuring safe and effective use of medical devices for patients and users is a crucial responsibility for manufacturers and developers, not only in terms of...

Source | Stewart Eisenhart
Dec 4, 2018
Hong Kong | In-Vitro Diagnostic Devices

In Brief: Hong Kong Regulators Launch Online IVD Classification Tool

EMERGO SUMMARY OF KEY POINTS:

  • Hong Kong regulators unveil online classification platform for IVD devices.
  • The MDCO IVD platform is designed similarly to an existing tool for medical devices.
  • MDCO medical device and IVD online classification tools are for reference purposes only.

The Medical Device Control Office (MDCO), Hong Kong’s medical device and IVD market regulator, has rolled out a new online platform to help IVD manufacturers classify their products according to the jurisdiction’s requirements.

The new MDCO...

Source | Stewart Eisenhart
Dec 3, 2018