May 10, 2019

EU publishes first corrigenda for MDR and IVDR in the Official Journal and further explains on UDI requirements

In order to fix inconsistencies, errors and slightly correct the European Medical Device and In Vitro Diagnostic Regulations (MDR and IVDR, respectively), two corrigenda have been published in the Official Journal of the European Union on May 3rd. Corrigendum to Regulation (EU) 2017/745 and Corrigendum to Regulation (EU) 2017/746.

April 30, 2019

New South Korea regulations released to promote commercialization of innovative devices and strengthen competitiveness of the healthcare industry

The Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food and Drug Administration (KFDA), has recently issued the In Vitro Diagnostic Medical Devices Act (IVD act), together with the Medical Devices Industry Development and Innovative Medical Devices Support Act (Medical Devices Industry Act) and few more relevant guidelines to keep fostering and supporting the Medical Device industry.

MArch 11, 2019

MHRA continues no deal planning to ensure UK is fully prepared for the exit day

If there is no deal with the European Union (EU) concerning the terms of the UK’s withdrawal from the EU, the UK’s current collaboration in the European regulatory network for Medical Devices and IVDs would end, and the Medicines and Healthcare products Regulatory Agency (MHRA) would take on the responsibilities for the UK market currently undertaken through the EU system.

February 22, 2019

Health Canada revisits the regulatory framework for Software as a Medical Device (SaMD)

The Canadian Health Authorities have revised regulatory compliance requirements for Software as a Medical Device (SaMD) and related emerging technologies, and are currently seeking stakeholder input on the recently developed Software as a Medical Device (SaMD) draft guidance document until March 29th, 2019.

January 25, 2019

Effective January, 2019: Updates on Medical Device Marketing Authorization (MDMA) procedures and most recent MDs and IVDs guidance

Early December last year, the Saudi Food and Drug Authority (SFDA) released the Announcement (1) 12/2018 containing the latest updates on Medical Device Marketing Authorization (MDMA) procedures. Being effective January 1st, 2019, Medical Devices Marketing Authorization (MDMA) certificates will be valid for a maximum period of three years.

January 17, 2019

FDA Proposes to End Temporary Extension of GUDID’s Grace Period to Improve UDI Data Quality

December 18th, 2018, the U.S. Food and Drug Administration (FDA) issued the public notice: Unique Device Identification System: Grace Period Change and Proposed Modifications to the Global Unique Device Identification Database (GUDID), and opened a docket for comments on its proposal to end the temporary extension of the GUDID grace period, which is due January 18th, 2019.

December 13, 2018

Medical Devices and clinical consumables: no-deal Brexit preparation plans update

The Secretary of State for Health and Social Care, Matt Hancock, has recently written to suppliers of Medical Devices and clinical consumables to update them on preparations for a potential no-deal Brexit. This letter explains what the health and care sector needs to consider in the period leading up to March 2019.

November 2, 2018

The new Medical Device and In Vitro Diagnostic Medical Device Regulations (MDR and IVDR, respectively) are coming, is anyone ready?

The new European Medical Device and IVD Regulations adopted in May 2017 replace the existing Medical Devices Directive (MDD), In Vitro Diagnostic Directive and Active Implantable Medical Devices Directive (AIMDD). The new regulatory framework will apply after a transitional period, which ends May 26th, 2020 (May 26th, 2022 for IVDs), and from that date on the new Regulations will fully apply.

October 18, 2018

Did you already start the transition to Medical Device Single Audit Program (MDSAP)? The clock is ticking!

As of January 1st, 2019, Health Canada will terminate the Canadian Medical Devices Conformity Assessment System (CMDCAS) program and Canadian Medical Devices Conformity Assessment System certificates will no longer be issued or accepted.