Asia Pacific Medical Technology Association (APACMed)

APACMed was on a panel at the U.S. Trade and Development Agency (USTDA)'s US-Vietnam Healthcare Workshop on Best Practices for Developing the New Medical Device Management Laws yesterday (31 Oct) in Vietnam. Nearly 100 participants across Vietnam’s healthcare ecosystem attended, including Vietnam's Deputy Minister of Health Nguyen Thi Lien Huong. Representatives and regulatory authorities from Singapore (Health Sciences Authority), Malaysia (Medical Device Authority), and the US (FDA) were also in attendance, including US Ambassador to Vietnam Marc Knapper. During a panel on "Industry Perspectives on Quality Management", Benish A., Government Affairs and Policy Lead at APACMed, shared that robust medical device quality management systems are critical foundations for sustainable healthcare delivery. It was highlighted that regulatory frameworks aligned with international standards are necessary for creating a healthcare market that attracts investment, promotes innovation, and ultimately improves health outcomes. The session also touched on opportunities to enhance regulatory convergence and reliance across markets. Miang (Chadaporn) T., Sharad Mi Shukla, RAC (US, EU), Asok kumar Raghavan Nair, Thuy Pham, Tram NguyenNgoc Benish A.

Like the diverse colours of festival lamps, we hope this Diwali brings you new opportunities, fresh perspectives, and unrestricted paths to success and happiness for you and your loved ones. APACMed India wishes you a wonderful and safe Diwali, along with a prosperous year ahead!

𝗧𝗵𝗲 𝟮𝟬𝟮𝟰 𝗗𝗮𝘀𝗵𝗯𝗼𝗮𝗿𝗱 𝗼𝗳 𝗘𝗻𝘃𝗶𝗿𝗼𝗻𝗺𝗲𝗻𝘁𝗮𝗹 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻𝘀 𝗳𝗼𝗿 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗶𝗻 𝗔𝗣𝗔𝗖 - 𝗘𝘀𝘀𝗲𝗻𝘁𝗶𝗮𝗹 𝗜𝗻𝘀𝗶𝗴𝗵𝘁𝘀 𝗳𝗼𝗿 𝗞𝗲𝘆 𝗠𝗮𝗿𝗸𝗲𝘁𝘀 We recently unveiled the 2024 edition of APACMed’s Dashboard of Environmental Regulations for MedTech in APAC, produced in collaboration with Bain & Company. APACMed first launched the dashboard in 2023 to provide clear and practical insights on navigating environmental policies in the MedTech space. We are delighted to announce that we’ve updated the dashboard with an increased coverage to 9 markets (up from 6 in 2023). Some key features of this year’s edition include: • Comprehensive MedTech-specific insights on 9 key markets: Australia, China, India, Japan, South Korea, Vietnam, Singapore, Thailand, and Malaysia. (The 2023 edition did not include the markets of Singapore, Thailand, and Malaysia) • A comparison tool to quickly assess differences in environmental regulations across markets. • A handy guide with essential highlights for each market's policies and regulations. Access the updated dashboard now (members access only): https://lnkd.in/dUVKy2kY Explore the 2023 dashboard (open access for all): https://lnkd.in/dRRSGesa Vikram Kapur, Miki Yu, Sudhanshu Sharma, Mayank Puri, Pravin Siriwardena, Abbott, B. Braun Group, Cardinal Health, CMR Surgical, Convatec, Cook Medical, Fresenius Medical Care, Johnson & Johnson, KARL STORZ, Medtronic, Olympus Corporation, Philips, ResMed, Roche, Siemens Healthineers, STERIS, Teleflex Medical OEM. For any queries about the Dashboard, please contact Benish Aslam and Jordan Lee.

𝗨𝗽𝗰𝗼𝗺𝗶𝗻𝗴 𝗘𝘃𝗲𝗻𝘁𝘀 𝗧𝗵𝗶𝘀 𝗡𝗼𝘃𝗲𝗺𝗯𝗲𝗿! We are excited to share our lineup of events. Explore our calendar for more details: https://lnkd.in/gEJMFmY4

𝗨𝗻𝗶𝗾𝘂𝗲 𝗗𝗲𝘃𝗶𝗰𝗲 𝗜𝗱𝗲𝗻𝘁𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 (𝗨𝗗𝗜) Mastering Unique Device Identification (UDI) is crucial in today's medical device industry, where effective traceability remains a top priority for quality control, inventory management, and patient safety. Stay ahead of the evolving regulations and learn how to leverage UDI to streamline traceability, optimise supply chain efficiency, and elevate patient standards with the APACMed eLearning Hub. The APACMed eLearning Hub features: - High-quality content created by APACMed’s Regulatory Affairs experts - Real-world insights on the latest regulations, technologies, and best practices - Virtual modules available on-demand - Certification to showcase your expertise Stay on top of your game by visiting the APACMed eLearning Hub now: https://apacmed.academy/

𝗔𝗣𝗔𝗖𝗠𝗲𝗱 𝗣𝗼𝘀𝗶𝘁𝗶𝗼𝗻 𝗣𝗮𝗽𝗲𝗿 𝗼𝗻 𝗣𝗼𝘀𝘁-𝗠𝗮𝗿𝗸𝗲𝘁 𝗦𝘂𝗿𝘃𝗲𝗶𝗹𝗹𝗮𝗻𝗰𝗲 𝗮𝗻𝗱 𝗩𝗶𝗴𝗶𝗹𝗮𝗻𝗰𝗲 How do we ensure that medical devices stay safe after they hit the market? APACMed's latest position paper on Post-Market Surveillance and Vigilance dives deep into the complexities and solutions for ongoing device monitoring. The paper covers: - Real-world challenges in post-market surveillance across APAC - Actionable, risk-based strategies to improve safety and vigilance systems - Recommendations to harmonise regulations with global standards like WHO & IMDRF This paper is crucial for anyone interested in advancing patient safety through smarter, more efficient oversight. Ready to learn how we can revolutionise post-market surveillance? Download the paper now: https://lnkd.in/g_VummjG A big thank you to contributions from: Asok kumar Raghavan Nair, Sharad Mi Shukla, RAC (US, EU), Yenny Anggoro, Yu Hosokai, NUR AQILAH IBRAHIM, BIVASH CHAKRABORTY, Chan Jeh Huei, Fithrotul Aini, Fleur Winslade, Ahn (Hannah), Lipi Chakhaiyar, Matthew Hein, Melissa Robins, Mita Rosalina, RAMA Sethuraman, Rezki Wahyu Meidayanti, RIMA EFRIANI, Yee Ling Tan, Victor Tan, Wirda Nelly, Yani Lina, Yasha Huang, Yean Ting Ong, Sook Voon Yong, Noemi Jimenez, CPCC, ACC Cindy Pelou, Devya Bharati

𝗖𝗮𝗻 𝗔𝗜 𝗗𝗲𝗹𝗶𝘃𝗲𝗿 𝗕𝗲𝘁𝘁𝗲𝗿 𝗣𝗮𝘁𝗶𝗲𝗻𝘁 𝗢𝘂𝘁𝗰𝗼𝗺𝗲𝘀? To unlock the full potential of AI for patient care, Dr. Brent James of Stanford University and a distinguished panel of experts delved into the critical questions surrounding this transformative technology. Moderated by Anastasia Miros of KPMG Singapore, the panel explored real-world applications, assessed challenges and opportunities, and discussed ways to optimize AI's integration into healthcare systems while preserving the essential human touch in patient care. Missed the session? Explore our forum highlights here: https://lnkd.in/gD9VCwUB 𝘕𝘰𝘵𝘦: 𝘍𝘶𝘭𝘭 𝘴𝘦𝘴𝘴𝘪𝘰𝘯 𝘳𝘦𝘤𝘰𝘳𝘥𝘪𝘯𝘨𝘴 𝘢𝘳𝘦 𝘢𝘷𝘢𝘪𝘭𝘢𝘣𝘭𝘦 𝘦𝘹𝘤𝘭𝘶𝘴𝘪𝘷𝘦𝘭𝘺 𝘵𝘰 𝘧𝘰𝘳𝘶𝘮 𝘢𝘵𝘵𝘦𝘯𝘥𝘦𝘦𝘴.

We are happy to share that APACMed has been selected for the "Outstanding Leadership in MedTech Advocacy in Asia-Pacific" award this year by BioSpectrum Asia in their upcoming Excellence Awards in December! 🎉 https://lnkd.in/gakMzQXv

📢 𝗔𝗣𝗔𝗖𝗠𝗲𝗱 𝗖𝗼𝗻𝘁𝗿𝗶𝗯𝘂𝘁𝗶𝗼𝗻 𝘁𝗼 𝗠𝗮𝗹𝗮𝘆𝘀𝗶𝗮’𝘀 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗔𝘂𝘁𝗵𝗼𝗿𝗶𝘁𝘆 𝗔𝗻𝗻𝘂𝗮𝗹 𝗪𝗼𝗿𝗸𝘀𝗵𝗼𝗽 The APACMed Regulatory Affairs (RA) Committee was honoured to participate yesterday (24 October) in the annual workshop hosted by Malaysia’s Medical Device Authority (MDA) and the local Conformity Assessment Body (CAB). Our RA SEA Chair, Sharad Mi Shukla, RAC (US, EU) of Johnson & Johnson trained participants on Digital Health Regulation and the Pre-Determined Change Control Plan (PCCP), building on our earlier workshop on Change Management with MDA. Our RA SEA Secretary, Chloe Tan from Medtronic presented a PCCP case study. Following the presentation, the RA delegation shared industry perspectives to help develop an effective and sustainable regulatory system. This forward-thinking initiative (PCCP) has the potential to streamline regulatory processes, allowing manufacturers to implement innovations more efficiently while maintaining safety and compliance, ultimately benefiting Malaysian patients. Special thanks to: Malaysia’s MDA, Muralitharan Paramasua, Aidahwaty M.Olaybal, Nurul Hidayah A.Azmi, and their team for considering the adoption of PCCP in Malaysia. Further thanks to: Sharad Mi Shukla, RAC (US, EU), Chloe Tan, Yean Ting Ong, Gaurav Verma, Liew Min, and Kiew Mei, Fong for contributing their expertise during this meaningful discussion. Cindy Pelou, Devya B.

A warm welcome to our latest start-up member, F.MED. F.MED specialises in developing robotic microsurgery assist systems to support precise handling of microscopic tools, which conventional robots are unable to achieve. The robot replicates surgeons' gestures with motions scaled down and hand tremor control to maximise both safety and effectiveness.