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Global Medical Device News

Canada | Medical Devices

Health Canada to Offer Pre-clinical Advisory Meetings to Medical Device Manufacturers



  • Health Canada’s Pre-Clinical Meeting program to provide feedback and recommendations to medical device manufacturers before they undertake clinical investigations.
  • Pre-Clinical Meeting program pilot to run from November 2018 to March 2019.
  • Formal Pre-Clinical Meeting guidance to be published following program pilot.

Canadian medical device regulator Health Canada is preparing a pilot for a new program allowing manufacturers to request meetings with the agency for feedback on proposed clinical...

Source | Stewart Eisenhart
Sep 11, 2018
United States | Medical Devices

US FDA Rolls Out Pilot for Simplified 510(k) Submissions


  • US FDA has launched a pilot program for streamlined 510(k) reviews using its eSubmitter software.
  • Eligible premarket notification applicants are not required to submit paper copies of their premarket applications to FDA.
  • FDA has set 60-day review timeframes for 510(k) applications submitted through the program, versus 90 days for standard 510(k) application routes.

The US Food and Drug Administration announced a new pilot program allowing qualified 510(k) medical device registrants to submit only...

Source | Stewart Eisenhart
Sep 10, 2018
Europe | Medical Devices

MDR Analysis: Does your medical device fall under the scope of new European regulations?

Now that the European Medical Device Regulation (MDR) is widely available, manufacturers and other industry participants can more accurately predict key issues that will affect them—including how and whether the scope of the new regulations covers their devices.

Note: This blog post was updated in October 2018 for accuracy.

The MDR text (see page 13 for the definition) as well as its accompanying Annex XVI (page 117) lay out clear indications as to which types of devices will have to...

Source | Ronald Boumans and Stewart Eisenhart
Sep 9, 2018
Brazil | Medical Devices

Brazil’s ANVISA Readies Regulations for Custom-made Medical Devices


  • ANVISA rolling out new regulations for custom-made medical devices
  • Requirements will cover commercialization, importing and manufacturing of such devices
  • The new regulations will replace ANVISA’s current “special request” process for custom and patient-specific devices

ANVISA, Brazil’s medical device market regulator, has issued a public consultation to establish new requirements pertaining to custom-made devices.

The new...

Source | Stewart Eisenhart
Sep 6, 2018
Australia | Medical Devices

Australian TGA to Accept Medical Device Approvals from Additional Overseas Regulators


  • Australia’s Therapeutic Goods Administration (TGA) plans to begin accepting certifications and approvals from additional foreign medical device regulators in addition to European CE Marking from market applicants.
  • TGA will recognize registrations and certifications from US FDA, Health Canada, the Japanese Pharmaceutical and Medical Devices Agency (PMDA) and Medical Device Single Audit Program (MDSAP) auditing organizations.
  • Australian market applicants may leverage approvals and registrations from these agencies for expedited TGA
  • ...
Source | Stewart Eisenhart
Aug 30, 2018
Europe | Medical Devices

Europe Update: Notified Body MDD, AIMDD Timelines


  • Some European Notified Bodies appear to have set early 2020 deadlines for renewals of CE Mark certifications under the Medical Devices Directive (MDD) and Active Implantable Medical Device Directive (AIMDD).
  • Manufacturers may find it increasingly difficult to obtain MDD and AIMDD certifications starting in late 2019.
  • These timelines should help manufacturers plan their transition strategies for Medical Devices Regulation (MDR) compliance.

Some Notified Bodies (NBs) will soon be designated to the Medical...

Source | Ronald Boumans
Aug 27, 2018
China | Medical Devices

China FDA Simplifies Documentation Requirements for Renewals, Clinical Trial Applications


  • The China Food and Drug Administration (CFDA) has loosened some requirements in Order No. 43 pertaining to registration renewal and clinical trial application documentation.
  • Changes affect analysis reports for renewals as well as home country and ethical committee approvals for clinical trials.

Chinese medical device market regulators have amended requirements for documentation related to registration renewals as well as clinical trial applications to simplify compliance.

First, according to Emergo...

Source | Stewart Eisenhart
Aug 24, 2018
Egypt | Medical Devices

Expanded Medical Device Regulations in Egypt Set for September 2018


  • Egypt’s Central Administration of Pharmaceutical Affairs (CAPA) will begin requiring registration for a broader swath of medical devices starting September 1, 2018.
  • All Class I sterile, Class IIa, Class IIb and Class III devices will fall under CAPA oversight.

Expanded medical device registration requirements in Egypt remain set to come into effect September 1, 2018, but affected companies should be familiarizing themselves now with new Central Administration of Pharmaceutical Affairs (CAPA) processes.


Source | Stewart Eisenhart
Aug 22, 2018
FDA GUDID Update: Combination product deadline extension, database records reach 1.8 million EMERGO
United States | Medical Devices

FDA GUDID Update: Combination product deadline extension, database records reach 1.8 million


  • US FDA is delaying GUDID submission requirements for some combination products by one year, to 2019.
  • The delay impacts combination products that undergo premarket review by the Center for Drug Evaluation and Research (CDER).
  • The latest GUDID submission data does not deviate from trends first identified by FDA in March 2018.


Source | Stewart Eisenhart
Aug 17, 2018
Brexit Update: New UK MHRA Guidance for Medical Device Companies Emergo
United Kingdom | Medical Devices

Brexit Update: New UK MHRA Guidance for Medical Device Companies


  • If there is a deal reached regarding the relationship between the UK and the EU after March 29, 2019 (“Brexit Day”), a transition period will apply that will last until December 31, 2020.
  • The European Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR) will become applicable in the UK.
  • The Clinical Trials Regulation will most likely become applicable. Should the implementation be postponed until after December 31, 2020, this Regulation will become UK law anyway.
  • A “cliff edge” Brexit is still an
  • ...
Source | Ronald Boumans
Aug 15, 2018