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Dear Esteemed Clients and Partners,
This issue holds promise of a canvas on which we can paint innovation, growth, and collaboration in the realm of medical devices together. Amongst a range of information about regulatory, technology and healthcare, there are a few key trade exhibitions in this coming month, to allow various potential partners to connect and engage. Without further ado, onward with Access-2-Healthcare’s April edition of MedTech Gateway!
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Two-way meeting between medical device authority (MDA), Malaysia and Ministry of Health (MOH), Indonesia.
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A Bilateral Meeting between MDA, Malaysia and the 'Ministry of Health, MOH, Indonesia was held online to discuss potential bilateral regulatory cooperation that will be implemented through the signing of an MOU.
This meeting was chaired by Puan Norlela Hatta Antah, Director, International and Industrial Relations Division (BHAI), MDA and attended by officers from the International Relations Branch, BHAI. While the Indonesian delegation was led by Tuan Dede Mulyadi, Director of Production and Distribution of Medical Device, MOH, Indonesia. Through this meeting, MDA and MOH, Indonesia have shared about the medical device regulatory system implemented in their respective countries.
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Anvisa will use regulatory information from foreign authorities to register medical devices |
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Anvisa published in the Official Gazette of the Union a Normative Instruction (IN) 290/2024, which establishes the optimized procedure for the purposes of analyzing the registration processes of medical devices.
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Thai FDA and Brazil's ANVISA Join the Discussion for Future Collaboration in Medical Device Regulation to Support the Health Economy |
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On March 26, 2024, at the Food and Drug Administration (FDA), Mr. Lertchai Lertvut, the Deputy Secretary-General of the Food and Drug Administration, welcomed representatives from the Brazilian Health Regulatory Agency (ANVISA), the Embassy of the Federative Republic of Brazil, and Brazilian Medical and Dental Devices Manufacturers Association (ABIMO). The Brazilian Health Regulatory Agency, or ANVISA (Agência Nacional de Vigilância Sanitária), is an entity under the Ministry of Health in Brazil, responsible for the supervision of health products such as medical devices, pharmaceuticals, food, cosmetics, sanitizing agents, and pesticide.
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The health ministry said Friday it will send more than 2,700 additional physician assistant (PA) nurses to hospitals to minimize medical system disruptions amid a prolonged walkout by trainee doctors.
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Clarius, ThinkSono unveil new AI-guided ultrasound tech in Europe |
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Clarius Mobile Health, a leading provider of high-definition handheld ultrasound systems, and ThinkSono, a pioneering medical technology company specializing in ultrasound artificial intelligence (AI) guidance solutions, are introducing a new AI-guided ultrasound system in Europe, which will improve the efficiency of detecting deep vein thrombosis (DVT). ThinkSono Guidance, an AI App that pairs with Clarius ultrasound scanners, recently attained Class llb CE mark regulatory approval.
Learn more →
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Steris to sell dental segment for $787.5M
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STERIS plc (NYSE: STE) (“STERIS” or the “Company”) today announced that the Company has entered into a definitive agreement to divest its Dental segment to Peak Rock Capital, a leading middle-market private investment firm, for $787.5 million (the “Transaction”). The Transaction is structured as an equity sale. The Transaction terms also include the opportunity for STERIS to receive an additional earnout of up to $12.5 million, subject to the achievement of certain revenue targets of the Dental segment in fiscal 2025.
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Design, Development, and Clinical Activities |
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A quick way to assess EU MDR/IVDR readiness |
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A dinner discussion on a Sunday evening.
Despite various attempts to not speak about work, topics from work still popped up between us diners.
“This CE marking… is so difficult now. We had to convince the Notified Body to work something out to guide us, and even when we signed a 2 years contract, 1.5 years on, we hadn’t achieved much”, one said.
“Yes! And most of the time we don’t really know what we don’t know!” says another.
Settling down after wolfing down pieces of delicious organic steamed salt chicken, I said: “there’s really just 3 things.
1. Clinical data – which gives you the basis of the clinical evaluation report. 2. Usability – whether this was done with the clinical study or was it ever done in the first place. 3. Cybersecurity – when applicable.
If any company has a working product, and can address the above 3 points, everything else can be arranged.”
“Is that all? What about all of the technical documentation” The first person asked.
“Most of the technical documents are already available by virtue of good engineering practices from a working quality management system – it is just a matter of gathering all of these information together. Yes – all of the inputs, outputs, validation/verification, risk. The GSPR already has a format and it just needs a bit of time to put it together! Add the IFU and label/UDI – that’s almost all there is to be created”.
It’s that ‘simple’. |
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The 89th China International Medical Equipment Fair (CMEF)
Shanghai, China
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The China International Medical Equipment Fair (CMEF) took place from April 11th to 14th, 2024 at the Shanghai National Convention and Exhibition Center under the theme "Innovative Technology, Leading the Future" stands as a global pinnacle in the field of medical and health technology. With its showcased over 10,000 innovative medical products from exhibitors worldwide, attracted nearly 5,000 brand enterprises from over 30 countries and regions globally, with an estimated attendance of over 200,000 professional visitors. The 89th CMEF was not only a platform for showcasing the latest medical technology achievements but also a crucial space for global communication and cooperation within the medical equipment industry from cutting-edge AI integration to high-level dialogues.
Read more → |
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