Medical Device License renewals are due five years after initial issue, and the process should be started at least four months before expiry.
We are delighted to share with you the attached just-published MedTech Europe final survey report, “Analysing the availability of Medical Devices in 2022 in connection to the Medical Device Regulation (MDR) implementation”. You may also access it on the MedTech Europe website. Please feel free to share it with your members and contacts as you wish.
The Botswana Medicines Regulatory Authority (BoMRA) through the department of Product Evaluation & Registration (DPER) will conduct a virtual stakeholder engagement session to update the relevant stakeholders on listing of medical devices, including In-Vitro Diagnostics (IVDs) devices.
“The COVID-19 pandemic really highlighted the far-reaching impact of the BioTech industry, with startups and companies biomanufacturing rapid testing kits, repurposed drugs, and vaccines”.
The 2022 Summit : For ‘Health’, the Summit will speak to the continuing impact of COVID-19 without letting the pandemic overshadow longer-term issues, such as digital platforms and investments for health systems. For ‘Development,’ the summit will explore the importance of trade, entrepreneurship, and digital innovations. Throughout the event, different sessions will foreground African voices including artists, startups, poets, authors, journalists, singers, painters, photographers, filmmakers, actors, and more, bringing diverse voices to these important issues.
Here is the full podcast episode (available on YouTube) with Hervé Mwamba and Dr Boitumelo Semete-Makokotlela, the CEO of the South African Health Products Regulatory Authority. SAHPRA’s job is to ensure that all health products (medical devices and medicines) are safe and operate the way that their manufacturers claim they operate. There is a discussion about topics such as the relationship of the regulator with industry, engagement and collaboration, alignment with already-existing systems and how to handle the pressure of leading an influential organization.
The In Vitro Diagnostic Regulation (IVDR) means enormous upheaval for companies, as now up to 90% of products will need to be reviewed by a notified body before they are eligible for distribution in Europe under the IVDR. That’s a huge about-turn from the situation under the In Vitro Diagnostic Directive (IVDD), where approximately 80% of products were self-declared to the IVD Directive.