Asia-Pacific Roundup: Japan’s PMDA shares principles for evaluating generative AI-enabled medical devices
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published “review points” for medical devices using generative AI.
The document, an English-language translation of a Japanese PMDA text published last month, applies to generative AI “that is implemented to generate diverse answers and creative content, that is not dependent on specific tasks, in response to a wide range of user inquiries through natural language text or speech inputs.” PMDA set out a need for specific regulation of generative AI.
“No sufficient framework has yet been established for the evaluation and risk management of GenAI technologies,” PMDA said. “GenAI is highly generalized and versatile, making it difficult to limit the scope of use. Judging output errors in natural language text or in another format leaves room for interpretation.”
Seeking to address the regulatory gap, PMDA has published principles for overseeing generative AI, including evaluation methodologies and postmarketing measures. The agency has yet to approve a generative AI-enabled medical device. Over time, PMDA plans to gather a wide range of opinions and refine its review points.
PMDA’s current principles reflect characteristics of generative AI-enabled medical devices that make it difficult to implement sufficient premarket evaluation of the products. Based on those characteristics, PMDA emphasizes a “total life cycle approach” that identifies properties subject to premarket evaluation and determines the extent to which they should be maintained through postmarketing management.
It may be acceptable to perform premarket evaluations of clinical efficacy and performance under specific conditions representing intended use, PMDA said. Acceptance would rely on the premarket evaluation status being maintained postmarketing, supported by a system for actively identifying and responding to incidents.
Premarket evaluation should focus on the usefulness and product performance of the outputs at a given point in time and under specified conditions. PMDA also plans to assess the stability and reproducibility of product performance outputs at different times and under different conditions while ensuring the absence of harmful outputs.
The PMDA document is part of a global move to regulate generative AI-enabled medical devices. In August, the US Food and Drug Administration published considerations for regulating the products. The devices hold transformative promise but may also introduce unique risks, FDA said.
AstraZeneca joins with Indian authorities to create inspection-ready clinical trial sites
AstraZeneca India has partnered with the National Institute of Pharmaceutical Education and Research (NIPER), Raebareli, to establish clinical trial infrastructure beyond metropolitan areas.
The collaborators aim to build a trained workforce and inspection-ready sites in 25 emerging research geographies across India. The partnership will support the Indian government’s broader ambitions to set up 1,000 trial sites in the country. Shri Manoj Joshi, secretary of India’s Department of Pharmaceuticals, outlined the case for investing in clinical trial infrastructure.
“Our country has the talent and expertise to play a larger role in global clinical trials,” Joshi said. “Strengthening clinical trials capabilities beyond major metropolitan centers will help expand the pool of skilled professionals and research-ready sites across the country.”
As a first step, the collaborators will adopt 25 clinical trial sites to provide proof of concept in oncology. After assessing the sites’ capabilities, AstraZeneca and NIPER Raebareli will offer the centers targeted training and mentoring to strengthen documentation and support processes related to the ethics, safety, and feasibility of clinical trials.
India’s Department of Pharmaceuticals will align the initiative with national clinical research priorities. AstraZeneca India will contribute clinical development expertise to design and deliver the program, as well as participate in training and workshops for the sites.
The combination of academic and industry expertise is intended to develop the workforce and create a model that can be expanded to other regions and therapeutic areas after the proof-of-concept stage.
Philippine FDA seeks feedback on draft GMP guidelines for medical devices
The Philippine Food and Drug Administration (FDA) has shared draft guidelines on good manufacturing practices (GMP) for medical devices.
FDA’s draft guidelines apply to Philippine manufacturers of medical devices, including in vitro diagnostics, and are designed to ensure products are made in accordance with applicable quality standards. The wide array of medical devices and the rapid emergence of new technologies make it essential for local manufacturers to adhere to recognized manufacturing and control standards, FDA said.
The agency has proposed adopting PNS ISO 13485:2019 as the official GMP guideline. The globally agreed International Organization for Standardization (ISO) standard sets out requirements for a quality management system specific to the medical devices industry.
FDA, which intends to automatically adopt all amendments and supplements to the ISO standard, will verify compliance with the requirements during GMP inspections. The agency plans to provide guidance on the conduct of GMP inspections and the issuance of GMP certificates in separate documents.
Officials have proposed giving the industry two years to comply with the guidelines. During the transition period, manufacturers may continue to apply their existing GMP standards. For now, FDA will assess existing standards when performing GMP inspections and issuing GMP certificates. Once the transition period ends, manufacturers will need to comply with the ISO standard.
FDA is seeking feedback on its proposals until 11 November.
Australia’s TGA outlines plans for digital scribe regulation after completing review
Australia’s Therapeutic Goods Administration (TGA) has outlined a planned approach to the regulation of digital scribes based on a recently concluded review.
Digital scribes are used to capture conversations between patients and healthcare practitioners. The tools generate clinical notes, summaries, and other outputs that may be added to patient records. TGA’s review found that not all digital scribes are medical devices. However, many digital scribes now include generative AI-enabled features that could bring the products under TGA’s oversight.
TGA found that many digital scribes include functions likely to meet the definition of a medical device. Yet none of the suppliers identified their products as medical devices. It appeared that some suppliers may not have previously considered medical device regulatory requirements, TGA said.
The agency identified a need for clearer guidance on when digital scribes are regulated as medical devices. Next steps include supporting continued education and regulatory guidance to help suppliers. TGA will also use the findings of its review to guide targeted compliance activities where digital scribes meet the definition of a medical device.
India’s CDSCO drafts step-by-step overview to aid compliance of IVD manufacturers
India’s Central Drugs Standard Control Organization (CDSCO) has provided draft guidance for in vitro diagnostic (IVD) manufacturers submitting product license applications through its online portal.
CDSCO designed the document to help domestic IVD manufacturers understand and comply with regulatory requirements. The draft features a step-by-step overview of the procedures, documentation, and regulatory obligations that apply to the sector.
The text outlines the documents essential to a manufacturing license application, including paperwork about device risk classification, essential principles of safety and performance, and the predicate device. Other objectives for the guidance include underscoring the importance of early regulatory engagement and proactive compliance planning.
CDSCO is holding a 15-day consultation into the draft guidance.
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Hong Kong has appointed Li Zili as the Controller for Medical Products Regulation. Li, who previously worked at the US FDA and Johnson & Johnson, is starting his three-year term as Hong Kong sets up the Centre for Medical Products Regulation. Press Release
