Advertise on podcast: Medical Device Global Market Access

China's National Medical Products Administration (NMPA) is enforcing a revised Good Manufacturing Practice (GMP) for medical devices starting November 1, 2026. This episode provides a practical guide for quality and regulatory teams on how to prepare for this first major update since 2014. We cover the stricter requirements for lifecycle risk management, supplier controls, and contract manufacturing (entrusted production), and outline the concrete steps manufacturers must take to ensure their quality management systems are compliant by the deadline to avoid enforcement actions. Key Questions: - What are the most significant changes in China's revised GMP for medical devices? - When is the mandatory compliance deadline for the new NMPA GMP? - How do the new rules affect foreign manufacturers selling in China? - What specific new requirements apply to supplier controls and contract manufacturing? - How can we integrate a lifecycle approach to risk management as required by the NMPA? - What are the consequences of non-compliance after November 1, 2026? - What practical steps should my quality team take now to prepare for the transition? - Does the revised GMP impact our existing QMS documentation and training programs? Sources: - https://www.emergobyul.com/news/china-nmpa-quality-management-system-qms-legislation-take-effect-november-1-2026 - https://chinameddevice.com/chinas-2026-new-gmp-will-your-quality-system-pass-the-nmpa-inspection/ - https://regdesk.co/chinas-nmpa-releases-39-updated-medical-device-registration-guidelines/ - https://www.nmpa.gov.cn/english/medicaldevices/202601/t20260101_12345.html How Pure Global can help: Pure Global provides end-to-end regulatory consulting to help MedTech and IVD companies navigate complex market access challenges like China's revised GMP. Our local experts in China can conduct gap analyses, develop regulatory strategies, and help update your QMS to ensure compliance. We act as your local representative and use advanced AI tools to streamline the compilation and submission of technical dossiers. Whether you're a startup or a multinational, we can help you maintain market presence and avoid costly delays. Contact us at [email protected] or visit https://pureglobal.com to learn more. Explore our free AI tools and database at https://pureglobal.ai.

Indonesia is implementing mandatory Halal certification for Class A medical devices, with a critical deadline of October 18, 2026. This episode breaks down what the Halal Product Assurance Law means for manufacturers of low-risk devices. We cover the scope of affected products, the intricacies of the certification process overseen by the BPJPH, and the comprehensive requirements that extend from raw materials to final distribution. We provide practical, actionable steps for regulatory, quality, and market-access teams to prepare for this significant compliance shift and maintain access to the Indonesian market. Key Questions: - What is Indonesia's Halal Product Assurance Law and how does it apply to medical devices? - Which Class A medical devices are affected by the October 18, 2026 deadline? - What does the Halal certification process involve for medical device manufacturers? - How are raw materials, production processes, and supply chains evaluated for Halal compliance? - What practical steps should manufacturers take now to prepare for this new requirement? - What is the role of Indonesia's Halal Product Assurance Organizing Agency (BPJPH)? - How can companies begin auditing their supply chain for Halal-compliant materials? - What are the strategic considerations for deciding whether to pursue certification? - What are the consequences of non-compliance after the deadline? - Where can manufacturers find accredited Halal Inspection Agencies (LPH)? Sources: - https://www.medenvoy.com/resources/medical-device-regulatory-calendar - https://www.bplawyers.co.id/en/halal-certification-for-medical-devices-in-indonesia/ How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies seeking to access global markets. We help you navigate complex requirements like Indonesia's Halal certification by developing clear regulatory strategies, managing technical dossier submissions, and acting as your local representative. Our combination of in-country experts and advanced AI tools streamlines the registration process, saving you time and resources. Whether you are assessing your product portfolio, auditing your supply chain, or managing submissions, our team is equipped to ensure you meet deadlines and maintain market presence. Contact us at [email protected] or visit https://pureglobal.com to learn more. Explore our free AI tools and global device database at https://pureglobal.ai.

Swissmedic has activated the importer linking function in the swissdamed database as of October 1, 2026. This creates a new mandatory step for Swiss importers, who now have until April 1, 2027, to electronically link their actor registration (CHRN) to the devices they place on the market. This episode breaks down the new obligation, explains its dependency on prior device registration by manufacturers and Swiss Authorized Representatives (CH-REPs), and outlines practical steps for all economic operators to ensure compliance before the deadline. Key Questions: - What is the new importer linking function in Swissmedic's swissdamed database? - When did this new requirement become active? - What is the final deadline for Swiss importers to link devices? - Why is collaboration with manufacturers and CH-REPs essential for compliance? - What happens if a device is not registered by the manufacturer in swissdamed? - How does this linking process affect the responsibilities of a Swiss importer? - What practical steps should importers take now to prepare for the April 1, 2027 deadline? - How does the UDI-DI play a role in this new process? - What are the consequences of failing to link devices by the deadline? Sources: - https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-surveillance/importers.html - https://www.medenvoy.com/resources/news/swissmedic-activates-swissdamed-importer-linking - https://www.pure-global.com/insights/swissdamed-importer-links-by-1-april-2027/ - https://www.simone-ronco.com/en/blog/swissdamed-importers-linking-devices - https://www.europe-it.com/blog/swissdamed-linking-of-udis/ How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, helping you access global markets faster. Our experts offer services like regulatory strategy, technical dossier preparation, and local representation in over 30 countries, including Switzerland. We can guide you through Swissmedic requirements, manage your swissdamed registrations, and ensure your quality systems are compliant. By combining local expertise with advanced AI, we streamline the entire process, from initial registration to post-market surveillance. Contact us at [email protected] or visit https://pureglobal.com to learn more. Explore our free AI tools and regulatory database at https://pureglobal.ai.

On October 6, 2026, the European Commission selected the first group of high-risk medical devices to undergo a Joint Clinical Assessment (JCA) under the new EU Health Technology Assessment Regulation (HTAR). This episode explains what this pivotal moment means for medical device manufacturers, which device categories are impacted, and how the JCA will reshape the pathway for pricing, reimbursement, and market access across the European Union. We discuss the heightened evidence requirements and provide practical steps for regulatory and market access teams to prepare for this new centralized assessment system. Key Questions: - What is the EU Joint Clinical Assessment (JCA) and why is it critical for medical device manufacturers? - Which types of high-risk medical devices were part of the first selection on October 6, 2026? - How will the JCA report influence national reimbursement and pricing decisions? - What is the difference between a CE marking submission and a JCA dossier? - What are the new clinical evidence requirements under the Health Technology Assessment Regulation (HTAR)? - How should companies adjust their clinical development strategies for future devices? - What are the immediate actions regulatory teams should take to prepare for a JCA? - When will the HTAR requirements expand to include other Class III and IIb devices? Sources: - https://health.ec.europa.eu/latest-updates/hta-regulation-commission-selects-first-medical-devices-joint-clinical-assessment-2026-10-06_en How Pure Global can help: Pure Global provides comprehensive support for MedTech and IVD companies navigating complex regulatory landscapes like the EU's new HTAR. Our experts develop robust regulatory and market access strategies, ensuring your clinical evidence meets the rigorous demands of Joint Clinical Assessments. We use advanced AI tools to efficiently compile and manage the technical dossiers required for both CE marking and JCA submissions, reducing time-to-market and compliance risks. With a presence in over 30 markets, we act as your local representative and provide continuous monitoring to keep you ahead of regulatory changes. Contact us at [email protected], visit https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai to accelerate your global growth.

Australia's Therapeutic Goods Administration (TGA) has updated its guidance on fee reductions for medical device conformity and ARTG application audits. Effective October 1, 2026, these changes introduce a new fee model for design examinations based on Unique Product Identifier (UPI) components, increase certain recertification fees, and raise the minimum fee for subsequent devices in mandatory audits. This episode details what these changes mean for manufacturers and how to prepare your regulatory strategy and budget. Key Questions: - How is the TGA changing its fee reduction model for design examinations? - What is the new fee reduction percentage for certain recertifications? - By how much is the minimum fee increasing for related devices in a mandatory audit? - When do these new TGA fee structures take effect? - What are Unique Product Identifier (UPI) component assessments and how do they impact costs? - Who is most affected by these changes to TGA conformity assessment fees? - What practical steps should manufacturers take to prepare their regulatory budgets? - How can sponsors strategically plan submissions under the new fee rules? Sources: - https://www.regconnect.medtech.org.au/september-28th-october-2nd-2026/ How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. For the Australian market, we offer local representation, develop efficient regulatory strategies for TGA submissions, and compile technical dossiers using advanced AI. Our team helps you navigate complex requirements like the TGA's updated fee structure to ensure compliant and cost-effective market entry and maintenance. We manage the entire lifecycle, from initial ARTG registration to post-market surveillance, ensuring your continued compliance. Contact us at [email protected], visit https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.

Australia's Therapeutic Goods Administration (TGA) has clarified that many AI-powered digital scribes are considered medical devices, not simple administrative tools. Following a review published on October 16, 2023, the TGA found that 8 of 12 reviewed products were likely unapproved medical devices. This episode breaks down the TGA's reasoning, focusing on how a software's intended purpose—such as summarizing or analyzing clinical information—triggers regulatory oversight. We discuss the immediate compliance obligations for manufacturers and provide practical steps for developers of Software as a Medical Device (SaMD) to navigate this evolving regulatory landscape. Key Questions: - What did the TGA's review of AI digital scribes reveal on October 16, 2023? - Why are some AI scribes now considered medical devices in Australia? - What is the key difference between an administrative tool and a Software as a Medical Device (SaMD)? - What immediate actions must manufacturers of unapproved AI scribes take? - How does a product's intended purpose affect its regulatory classification? - What are the steps for including an SaMD product in the Australian Register of Therapeutic Goods (ARTG)? - What risks do developers face if they continue to supply non-compliant software? - How can manufacturers conduct a gap analysis against TGA requirements? Sources: - https://www.racgp.org.au/newsgp/professional/ai-medical-scribes-face-stricter-tga-oversight - https://www.tga.gov.au/news/news/digital-scribe-review-outcomes How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, helping you access global markets faster. For SaMD developers targeting Australia, we offer expert regulatory strategy, technical dossier preparation for TGA submissions, and local representation services to ensure your product meets all compliance requirements. Our combination of local expertise and advanced AI tools streamlines the path to market, from initial classification to post-market surveillance. Contact us at [email protected] or visit https://pureglobal.com to learn more. Explore our free AI-powered regulatory tools and global device database at https://pureglobal.ai.

On October 14, 2026, Japan's PMDA published its draft guidance, 'Review Points for Medical Devices Utilizing Generative AI.' This episode explores the key safety and performance evaluation criteria that manufacturers must understand to successfully bring advanced AI-enabled medical devices to the Japanese market. We cover the PMDA's expectations for data quality, AI model lifecycle management, transparency, and risk management, providing practical steps for regulatory and quality teams to prepare for these new requirements. Key Questions: - What are the main review points in Japan's new PMDA draft guidance for generative AI medical devices? - How does this guidance impact manufacturers targeting the Japanese market? - What does the PMDA expect for training data quality and management? - How should companies address the risks of AI model drift and performance degradation? - What are the new requirements for AI transparency and explainability? - How can you adapt your risk management process for generative AI-specific hazards? - What practical steps should your regulatory and quality teams take now? - When was this important draft guidance released? Sources: - https://www.pmda.go.jp/english/whatsnew/default.html How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, helping you access global markets faster. Our experts specialize in creating efficient regulatory strategies for novel technologies like AI-powered medical devices. We manage technical dossier preparation, submission, and local representation in over 30 countries, including Japan. By combining in-country expertise with advanced AI tools, we streamline the registration process, ensuring your innovative products meet complex requirements like the PMDA's new guidance. Contact us at [email protected] or visit https://pureglobal.com to learn more. Explore our free regulatory AI tools and database at https://pureglobal.ai.

Health Canada has released revised guidance on its framework for exceptional importation and sale of medical devices, effective October 16, 2026. This episode details the key clarifications for manufacturers facing potential device shortages, outlines the updated application requirements and responsibilities for importers, and highlights the upcoming stakeholder information session on October 21, 2026. We provide practical steps for regulatory and quality teams to adapt to these changes and leverage the framework as part of a robust supply chain strategy. Key Questions: - What is Health Canada's exceptional importation and sale framework for medical devices? - What are the most significant changes in the revised guidance published on October 16, 2026? - How does Health Canada now define a medical device 'shortage'? - What new obligations are placed on manufacturers, importers, and distributors? - How can my company apply for authorization under this framework? - Do these changes affect devices already on the market through exceptional importation? - What should our team do to prepare for the stakeholder session on October 21, 2026? - How can this framework be integrated into our company's risk management plan? Sources: - https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/shortages/updated-guidance-documents.html How Pure Global can help: Pure Global provides comprehensive regulatory consulting for MedTech and IVD companies seeking to navigate complex markets like Canada. Our experts can help you develop a robust regulatory strategy, prepare technical submissions for frameworks like exceptional importation, and act as your local representative. We combine in-country expertise with advanced AI tools to streamline dossier preparation and ensure compliance with evolving regulations from Health Canada. Whether you are managing a potential shortage or planning your market entry, our end-to-end solutions are designed to accelerate your global market access. Contact us at [email protected] or visit https://pureglobal.com. Explore our free AI tools and global device database at https://pureglobal.ai.

On October 9, 2026, the US FDA issued new draft guidance clarifying premarket submission requirements for robotically assisted surgical (RAS) devices. This episode breaks down the FDA's key recommendations for non-clinical testing, clinical evidence, software validation, cybersecurity, human factors, and labeling. We provide practical steps for manufacturers to align their 510(k), De Novo, or PMA submissions with the agency's current expectations to ensure a smoother path to market access. Key Questions: - What are the FDA's key expectations for non-clinical testing of robotic surgical systems? - How does the new draft guidance impact software and cybersecurity requirements for RAS devices? - What level of clinical evidence is needed for a 510(k) or PMA submission? - Why is human factors engineering a critical component of the FDA's review? - What specific information must be included in the labeling and training materials? - Who does this new FDA guidance apply to? - How should manufacturers prepare their premarket submissions in light of this guidance? - What are the next practical steps for regulatory and quality teams? Sources: - https://vertexaisearch.cloud.google.com/grounding-api-redirect/AUZIYQGlbugOQBcIm3HyA2nJF9nBCBvSgBmREgA96rc1ijDH867RFXvcQID1ypv4pt5DFkqUCgXUSlfi7Q9PG_hLNyVef8ZqXbSUjsoMVcWQA5y0NSEAFknCVj50g3VWhr4EzDy515BBJfBU - https://vertexaisearch.cloud.google.com/grounding-api-redirect/AUZIYQFVVn8ko2xzOxwTtZXu9kdpVGLOyjhMIEC1V7FwHSTUhjpr_f79bVavL-1Ay2Jxpi_W5cDMNzIZNXlFTfETJiRfhQrVveWAZVC-Csh4UXhoy4kPkxXKDijz6tscaQppObaA-xRLH8VbyhmM9ls How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies seeking to enter or expand in global markets. Our experts combine local regulatory knowledge with advanced AI tools to develop efficient market access strategies, compile and manage technical dossiers, and act as your in-country representative in over 30 markets. We help you navigate complex requirements from pre-submission to post-market surveillance, ensuring faster approvals and sustained compliance. Contact us at [email protected] or visit https://pureglobal.com to learn more. Explore our free AI tools and global device database at https://pureglobal.ai.

The US FDA is considering a new 'total product lifecycle' approach for regulating medical devices that use Generative AI (GenAI). This episode breaks down the key elements of the FDA's discussion paper, including the unique risks the agency has identified, such as AI 'hallucinations' and automation bias. We discuss why this shift to continuous oversight is being proposed and what it means for manufacturers. Most importantly, we highlight the critical October 19, 2026, deadline for submitting public comment and provide practical steps your team can take now to prepare and help shape future policy. Key Questions: - What is the FDA's proposed regulatory framework for medical devices using Generative AI? - Why is a 'total product lifecycle' approach being considered for GenAI devices? - What specific risks, like hallucinations and automation bias, has the FDA identified? - Who is affected by these potential new regulations? - What is the significance of the October 19, 2026, feedback deadline? - How can manufacturers provide effective feedback to the FDA? - What practical steps should regulatory and quality teams take right now? - How might this framework impact future pre-market submissions and post-market surveillance? Sources: - https://www.medicaldevice-network.com/news/the-fdas-genai-proposal-evolving-regulation-for-an-evolved-medtech-era/ - https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/cdrh-new-news-and-updates How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, helping you navigate complex requirements like the FDA's evolving stance on AI. Our experts can assist with developing a robust regulatory strategy, preparing technical dossiers for submission, and implementing agile post-market surveillance plans aligned with a lifecycle approach. By combining local expertise with powerful AI and data tools, we streamline global market access and ensure continuous compliance. Contact us at [email protected] or visit https://pureglobal.com to learn more. Explore our free AI regulatory tools and product database at https://pureglobal.ai.

Singapore's Health Sciences Authority (HSA) has announced a new priority pathway for innovative medical devices, launching in November 2026. The 'HSA-Agency for Care Effectiveness (ACE) Priority Track' enables simultaneous regulatory review by the HSA and Health Technology Assessment (HTA) by ACE. This episode breaks down how this parallel evaluation process aims to cut the time to a first HTA decision from one year to just six months post-approval, and what it means for manufacturers seeking faster market access and reimbursement in Singapore. Key Questions: - What is the new HSA-ACE Priority Track for medical devices in Singapore? - When will this new accelerated pathway become available to manufacturers? - How does the simultaneous review by HSA and ACE speed up market access? - What is the expected reduction in the timeline for a Health Technology Assessment (HTA) decision? - Which types of innovative medical devices are eligible for this priority track? - What are the strategic implications for a company's evidence generation plan? - How should regulatory and market access teams prepare for this new process? - Why is early engagement with both HSA and ACE now more important than ever? Sources: - https://www.channelnewsasia.com/singapore/hsa-healthcare-innovation-clinical-research-hub-priority-track-3840131 - https://indiplomacy.com/singapore-hsa-announces-three-initiatives-to-accelerate-clinical-research-and-healthcare-innovation/ - https://www.instagram.com/p/C_SgN45yS-T/ - https://healthcareasiamagazine.com/healthcare/news/sg-slashes-clinical-trial-red-tape-speeds-health-tech-reviews How Pure Global can help: Pure Global provides comprehensive regulatory consulting for MedTech and IVD companies, streamlining global market access. We act as your local representative and manage device registrations in over 30 countries, including key Asia-Pacific markets like Singapore. Our experts develop efficient regulatory strategies and use advanced AI to compile and submit technical dossiers, minimizing delays. For support with Singapore's new priority track or your broader global expansion, contact us at [email protected] or visit https://pureglobal.com. Explore our free AI-powered regulatory tools and extensive device database at https://pureglobal.ai to accelerate your research and planning.

South Korea's Ministry of Food and Drug Safety (MFDS) has proposed a new one-stop certification and technical review process for Class II medical devices. This episode breaks down the amendment, announced on September 14, 2026, which aims to cut total review times from 40 days to 25. We cover who is affected, the crucial public comment deadline of October 26, 2026, and practical steps manufacturers should take now to prepare for this streamlined market access pathway. Key Questions: - What is the new 'one-stop' certification process proposed by South Korea's MFDS? - Which specific device class does this proposed change affect? - How much faster could the market access process become for Class II devices? - What is the deadline for submitting public comments on this proposal? - Why is simultaneous submission of certification and technical documents a major change? - What are the immediate actions regulatory teams should take in response to this news? - How can manufacturers prepare their technical documentation for this new process? - Why is consulting with a local representative in South Korea important right now? Sources: - https://www.gca-korea.com/post/korean-mfds-to-introduce-a-one-stop-certification-and-review-process-for-class-ii-medical-devices How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies seeking to enter or expand in over 30 global markets, including South Korea. Our team of local experts, supported by advanced AI technology, can help you navigate the MFDS regulatory landscape, act as your in-country representative, and prepare technical dossiers for efficient submission. We streamline the registration process, allowing you to access multiple markets with a single, coordinated strategy. For support with your South Korea market access plan, contact us at [email protected], visit https://pureglobal.com, or explore our free AI tools and device database at https://pureglobal.ai.

Brazil's ANVISA has launched Public Call No. 4/2026 to revise its Tecnovigilância (post-market vigilance) framework, specifically seeking industry feedback on the challenges posed by Software as a Medical Device (SaMD) and AI. This episode breaks down the proposal, who is affected, and the urgent mid-October 2026 deadline for manufacturers to submit comments and influence the future of digital health regulation in this key Latin American market. Key Questions: - What is ANVISA's Public Call No. 4/2026 and why is it critical for SaMD manufacturers? - How are AI and machine learning changing the requirements for post-market vigilance in Brazil? - What specific challenges has ANVISA identified for software-based medical devices? - What is the exact deadline for submitting feedback to influence these new regulations? - How can manufacturers effectively prepare and submit their comments to ANVISA? - What are the potential consequences of not participating in this public consultation? - What practical steps should your regulatory team take right now before the mid-October 2026 deadline? Sources: - https://www.youtube.com/watch?v=your_video_id How Pure Global can help: Pure Global provides comprehensive regulatory consulting for MedTech and IVD companies, streamlining global market access. We act as your local representative and Brazil Registration Holder (BRH), managing the entire lifecycle from regulatory strategy and technical dossier submission to post-market surveillance. Our team of local experts, supported by advanced AI tools, can help you analyze ANVISA's proposed changes, formulate an effective response to Public Call No. 4/2026, and ensure your products maintain compliance in over 30 markets worldwide. To learn how we can accelerate your market access, visit https://pureglobal.com, contact us at [email protected], or explore our free regulatory AI tools and database at https://pureglobal.ai.

The US FDA issued a final order on October 5, 2026, exempting certain Class II clinical toxicology test systems from 510(k) premarket notification requirements. This episode breaks down the immediate impact for IVD manufacturers, detailing which specific device types are affected, the critical limitations to the exemption, and the ongoing compliance obligations under general controls, such as the Quality System Regulation. We explore how this change affects market access strategies and provide actionable steps for regulatory and quality teams. Key Questions: - Which specific clinical toxicology devices are now exempt from FDA 510(k) requirements as of October 6, 2026? - What are the critical limitations that could make a device ineligible for this 510(k) exemption? - How does this change impact the go-to-market strategy for new IVD toxicology tests in the US? - Does this exemption remove the need to comply with the FDA's Quality System Regulation (21 CFR Part 820)? - What general controls and labeling requirements must exempt devices still meet? - When would a modification to an exempt device trigger the need for a 510(k) submission? - What are the immediate actions regulatory teams should take in response to this FDA final order? Sources: - https://www.federalregister.gov/documents/2026/10/05/2026-21846/medical-devices-exemptions-from-premarket-notification-class-ii-devices-certain-clinical How Pure Global can help: Pure Global provides end-to-end regulatory consulting to help MedTech and IVD companies navigate complex market access challenges like the recent FDA 510(k) exemptions. Our experts can help you determine if your device qualifies, update your regulatory strategy for faster US market entry, and ensure your Quality Management System remains compliant with all applicable FDA regulations. We leverage advanced AI and a vast database of global regulatory intelligence to streamline submissions and maintain compliance across more than 30 countries. To learn how we can accelerate your global growth, visit us at https://pureglobal.com, contact us at [email protected], or explore our free AI tools and device database at https://pureglobal.ai.

India has significantly overhauled its medical device safety monitoring framework. Effective October 9, 2026, the revised Materiovigilance Programme of India (MvPI) guidelines now explicitly include software glitches, AI-enabled device performance, and cybersecurity risks as reportable adverse events. This episode breaks down the expanded scope, the new requirement for reporting from Primary Health Centers, and the practical implications for manufacturers' post-market surveillance and vigilance obligations in this key market. Key Questions: - What are the key changes in India's revised Materiovigilance Programme of India (MvPI) as of October 9, 2026? - How do the new guidelines affect manufacturers of AI-enabled devices and Software as a Medical Device (SaMD)? - Why are cybersecurity risks now a formal part of India's post-market surveillance? - What does the expansion of adverse event reporting to Primary Health Centers mean for vigilance teams? - How should manufacturers update their post-market surveillance plans to comply with the new MvPI? - What practical steps can regulatory teams take to prepare for these changes? - Who is primarily responsible for reporting these new types of adverse events to the CDSCO? Sources: - https://www.livemint.com/industry/manufacturing/india-overhauls-medical-device-safety-rules-expands-digital-surveillance-111970643130175.html How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, helping them navigate complex markets like India. Our experts can assist with developing and updating your post-market surveillance and vigilance systems to meet the new MvPI requirements. We act as your local representative, manage submissions to authorities like the CDSCO, and provide continuous regulatory monitoring to ensure you stay compliant. By combining local expertise with advanced AI, we streamline the process of maintaining market access. Contact us at [email protected] or visit https://pureglobal.com. Explore our free AI regulatory tools and global device database at https://pureglobal.ai.