The International Medical Device Regulators Forum (IMDRF) recently posted a series of updated guidelines on the group’s standard operating procedures (SOP), criteria for joining, its mission and scope, as well as application forms for joining.   IMDRF is a voluntary group of medical device regulators formed in 2011, and its goal is to accelerate international medical device regulatory harmonization and convergence. Members consist of medical device regulatory authoriti...

The European Commission has issued rules outlining the circumstances in which medical device instructions for use (IFU) can be provided in electronic form, rather than in paper form.   The implementing regulation , issued on 14 December, brings the European Union into alignment with device regulators in the US, Australia, and other nations, which already allow electronic labeling/IFU for certain medical devices. (RELATED: TGA Offers Guidance on Electronic Instructio...

The EU Medical Device Regulation (MDR) has been published with new medical device software (MDSW) requirements. Qualification guidance to determine if software is MDSW was combined with guidance for MDSW classification. However, the EU Medical Device Directive (MDD) guidance for clinical evaluation, which should have been replaced, is still in use. The change to the MDR has introduced new problems for clinical evaluation, so guidance has been introduced for equivalence, le...

China’s National Medical Products Administration (NMPA) has joined an International Medical Device Regulators Forum (IMDRF) program that allows for the rapid exchange of safety and adverse event data, according to reports from the IMDRF meeting in Russia last month. NMPA now joins regulators across Europe, Australia, Canada, Japan, Singapore and the US in the IMDRF National Competent Authority Report Exchange, according to a report from state media last month. The ...

In its first guidance document to deal exclusively with the cybersecurity of medical devices, the International Medical Device Regulators Forum (IMDRF) this week released new general principles and best practices to facilitate better international regulatory convergence on the topic. The 45-page guidance document, developed by a working group led by officials from the US Food and Drug Administration (FDA) and Health Canada, includes both pre-market and post-market cyber...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Adopts Risk-Based Model for Fecal Microbiota Transplants   Australia’s Therapeutic Goods Administration (TGA) has adopted a risk-based approach to the regulation of fecal microbiota transplants (FMT). TGA decided to treat FMT products as anything from Class 1 biologicals to Class 4 medicines after running a public consultation earlier in the year.   The model...

While highlighting an updated version of the manufacturer incident report (MIR) form that will become mandatory in January 2020, the European Commission (EC) issued guidance Tuesday on the medical device vigilance system under the EU’s medical device directive.   The January version of the MIR introduces the use of the adverse event terminology/coding harmonized via the International Medical Device Regulators Forum (IMDRF) and the use of unique device identification (U...

Medical device regulators launched new initiatives on harmonizing in vitro diagnostic (IVD) regulations and tweaking the Medical Device Single Review Program (MDSAP) for additional countries to participate. A new working group (WG) was established to take up new work on IVDs and was approved at the last International Medical Device Regulators Forum (IMDRF) management committee meeting in Russia in March. A new category for interested countries to participate in MDSAP ...

The International Medical Device Regulators Forum (IMDRF) proposed updates on Wednesday to clinical evaluation documents in support of rapid market entry across multiple jurisdictions. The IMDRF’s medical devices clinical evidence working group (MDCE WG) re-issued consultations Wednesday to propose updates to three Global Harmonization Task Force (GHTF) documents from 2007 and 2010. The MDCE WG’s consultation documents seek to reflect the recently implemented and/or ...

Medical device industry delegates and global regulatory authorities are looking to further support their collaboration with standards development organizations (SDOs) through a newly proposed liaison program. Scott Colburn, director of the standards program at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), pitched an International Medical Device Regulators Forum (IMDRF) new work item (NWI) during a workshop hosted by the IMDRF s...

The International Medical Device Regulators Forum (IMDRF) issued a final assembly and technical guide on building submissions using the IMDRF Table of Contents (ToC) structure, including harmonized technical guidelines on the acceptable folder structure and file format(s) for ToC-based submissions. The final guide was posted on Wednesday after IMDRF convened in Moscow—Russian regulators are currently chairing IMDRF—for a three-day open stakeholders forum that kicked off...

Health Canada is seeking industry feedback on guidance that describes its plan to formally implement the Table of Contents (ToC) structure, established by the International Medical Device Regulators (IMDRF) for a harmonized approach to the format of medical device market authorization applications. The implementation guidance identifies how Health Canada will adopt ToC formats as part of its efforts to support the global convergence of documentation requirements for m...