INDIA

Central Drugs Standard Control Organization under Ministry of Health & Family Welfare becomes Affiliate Member of the International Medical Device Regulators Forum

The Ministry of Health and Family Welfare has introduced comprehensive regulations for medical devices aimed at aligning the country's regulatory framework with globally accepted standards. This initiative seeks to foster a regulatory ecosystem that promotes growth and innovation in the medical device sector.
To achieve global alignment in its medical device regulatory system, enhance the competitiveness of the domestic industry, and boost transnational prominence, the Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, applied for Affiliate Membership in the International Medical Device Regulators Forum (IMDRF) in 2024. After review of India’s application for Affiliate membership and meeting discussions by the IMDRF Management Committee (MC) with the senior officers of CDSCO during the 26thSession of IMDRF held in September 2024 at Seattle, Washington, USA, the CDSCO has received approval from IMDRF as an Affiliate Member of the Forum.

JAPAN

Public tender announcement (Procurement of SAS license (continuation) for equipment for analyzing data such as medical receipt information in FY2024)

The Pharmaceuticals and Medical Devices Agency has announced a public tender for the procurement of a SAS license, which is essential for the continued analysis of medical receipt information and related data for fiscal year 2024. This competitive bidding process aims to identify a qualified vendor capable of delivering the necessary equipment and services by the specified deadline. As the agency seeks to enhance its capabilities in data analysis, it invites interested parties to submit their bids by the stipulated date, ensuring transparency and fairness in the selection process. This announcement outlines the key details, including the subject of procurement, delivery timelines, and the bidding method.

AUSTRALIA

South African and Australian health product regulators to share regulatory information and expertise

The South African Health Products Regulatory Authority (SAHPRA) and the Australian Therapeutic Goods Administration (TGA) have signed a Memorandum of Understanding (MoU), which will strengthen collaboration between the two health product regulators. The MoU builds on the existing relationship between the health products regulators to improve capabilities in the assessment of medical products and therapeutic goods and their monitoring for continued efficacy, safety and quality once they are registered.

SWITZERLAND

Update: Countries in South-East Asia Region, partners pledge over USD 345 million, including in-kind contributions, at special WHO Investment Round Event

At a special ceremony to highlight the importance of investment in WHO and global health, countries of the WHO South-East Asia Region and key partner organizations pledged over USD 345 million, including important in-kind contributions, in financing for the organization.

UNITED STATES

Clario and PathAI Collaborate to Deliver Integrated Solution for GI Clinical Trials

Clario, a leading provider of endpoint data solutions to the clinical trials industry, is excited to announce a strategic partnership with PathAI, a leader in AI-powered digital pathology solutions aimed at improving diagnostic accuracy and efficiency. This collaboration offers a single-vendor solution for efficient anatomical pathology services and next-generation video endoscopy analysis.

UNITED STATES

Caldera Medical Acquires UVision360 and the LUMINELLE Product Family, Expanding Minimally Invasive Hysteroscopy Portfolio

Caldera Medical, a leader in women’s health medical devices, announced today the acquisition of UVision 360, Inc., the developer of the LUMINELLE® hysteroscopy and cystoscopy systems. This strategic acquisition bolsters Caldera Medical’s minimally invasive solutions, particularly in the realm of advanced hysteroscopy, broadening its portfolio for the diagnosis and treatment of conditions such as polyps, fibroids, and intrauterine pathology.

VIETNAM

Vietnam's Vingroup considers selling stakes in its AI firms to global tech giants, including Nvidia

Vingroup, the largest private conglomerate in Vietnam, is in the process of selling its stakes in two artificial intelligence (AI) - focused firms, VinBrain and VinAI.
This is according to three sources with knowledge of the matter, who shared the information with The Business Times on condition of anomymity.

MedTech Conceptualisation

The Doctor is not always right.

So, what if doctors conceptualise the medical device? Can’t other functions do just as good? We often laud doctors, nurses, and other clinicians who conceptualise and create innovative ideas that would lead to new devices, thinking that ‘this is what doctors want.’

Oftentimes it is forgotten that this is taken in context to the clinician’s situation, which may differ in other countries, or even between the clinician’s own colleagues in the same hospital! Indeed, it is important to ‘scan the horizon’ to understand.

- Are there similar devices already launched in the market?
- If yes, why would my invention be miles better than the current offerings?
- How do similar devices sell to the customer? Who is the actual customer?

To a marketer or a researcher, having the right questions, would allow them to search for the answers rather easily. But to a clinician, it is a monumental task - because most clinicians are not adept at researching information.
This scan and understanding of the value proposition of the new device in view of global markets is the first key step for any clinician.
Sometimes, new devices can be conceptualised but NOT meant for the clinician! This is when the ultimate beneficiary is the patient, or the government. Then it no longer makes sense to ‘ask the clinician’ if this device would work in various markets.

Overall, context is important.

Still clear as mud?

THE 90TH CHINA INTERNATIONAL MEDICAL EQUIPMENT FAIR (CMEF)

The 90th China International Medical Equipment Fair (CMEF) is being held in Shenzhen from October 12th to 15th, 2024. This event is expected to attract over 200,000 visitors from more than 150 countries, making it a prominent global platform for showcasing the latest technologies. With participation from over 4,000 enterprises, the exhibition highlights cutting-edge innovations in medical equipment. China's medical device market has experienced impressive growth, with a market value of 1.27 trillion yuan ($179 billion) in 2023, according to China Daily. Discover what we observed at the event in our blog post.

TECHWEEK 2024

Techweek 2024 was the premier event for all things technology: with 7 co-running events for attendees specific interest: Cloud Expo Asia, DevOps Live, Cyber Security World Asia, Big Data & AI World Asia, Data Centre World Asia, eCommerce Expo Asia and Technology for Marketing Asia. Held from 9-10 October 2024, it saw more than 26,000 attendees, and over 500 global exhibitors. You may be wondering…what were we doing attending a tech-trade show? Have we pivoted from healthcare to tech?

Well, not exactly. Amongst the likes of futuristic AI chatbots, cloud systems and data analysis tools, there was a small subset of Software as Medical Device (SaMD) companies exhibiting at the show, looking to break into the Singapore market with their innovative solutions for healthcare. After speaking with some of them, it was inspiring to get a glimpse of how technology has opened the door to improve clinical workflow, increase efficiencies, and even provide solutions we may have only dreamed of in the past. It remains to be our mission to help bring groundbreaking ideas from startups from conceptualization to reality, so while we help with this batch of startups – We are hopeful to see an even bigger medical device company turnout at Techweek next year.