Promoting Medical Device Regulatory Harmonization: Key Takeaways from the 27th IMDRF Conference in Japan

The 27^th International Medical Device Regulators Forum (IMDRF) conference, held this week in Japan, gathered regulators and industry representatives to discuss the organization’s five-year strategic plan.

Stakeholders recommended that the IMDRF should focus on initiatives that foster regulatory efficiency, harmonization and convergence. Key areas include standardized submission format, post-approval change management, post-market surveillance and electronic IFU.  How national regulatory agencies approach emerging technologies early, especially AI and machine learning-enabled medical devices, is also a high priority. 

Specifically, the IMDRF is working on the development of a reliance playbook.  The reliance playbook aims to promote understanding among stakeholders of the opportunities and benefits of implementing reliance, as well as encourage collaboration and trust amongst national regulatory authorities by sharing knowledge and experience, and provide strategies and practical examples of successful reliance models.

In Europe, the Medicines and Healthcare products Regulatory Agency (MHRA) is willing to rely on assessments performed in the EU, Canada, Australia and the U.S. to accelerate the marketing authorization approval process. In the Asia Pacific, the Therapeutic Goods Administration (TGA) has been expanding pre-market reliance through recognizing comparable overseas regulators in the EU, Canada, Japan, the U.S., Singapore and Brazil.  

Regulatory assessment and clinical evaluation evidence submitted to these comparable overseas regulators can be relied by the TGA to potentially ease the burden of marketing authorization applicants.  The TGA also acknowledges post-market reliance by referencing audit reports of manufacturing facilities produced by comparable overseas regulators or notified bodies to identify risks and determine appropriate compliance actions.  It was apparent that the medtech industry welcomes regulatory reliance across the product life cycle. 

Selected national regulatory authorities reported their respective regulatory updates.  These include: 

• The TGA in Australia is ready to launch the UDI and will allow manufacturers to voluntarily choose eIFU together with physical copies.  TGA is also soliciting public comments on how to regulate AI-enabled therapeutic products and technologies.  The Australian medical device regulatory framework is technology agnostic and may only need minor amendments to mitigate AI-related risks to patients. 
• The draft Medical Device Administrative Law in China is under an inter-agency deliberation, which may take at least six months.  The National Medical Products Administration (NMPA) continues to promote manufacture localization of the imported medical devices and will announce updated guidance that address emerging technologies, such as AI and medical robots. 
• The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan developed guidelines for the approval review and marketing authorization for SaMD and organized several forums involving the PMDA, academia and industry representatives to drive a more supportive regulatory system.  Healthcare institutions in Japan must ensure cybersecurity when using digital technology in clinical practices and safeguard the confidentiality, integrity and availability of medical information systems. 
• The Health Sciences Authority (HSA) in Singapore continued to implement the UDI on high risk medical devices.  It also rolled out an optional change management program for SaMD that allows marketing authorization applicants to pre-specify SaMD post-approval changes when applying for the marketing authorization.  Manufacturers are allowed to implement the approved post-approval changes through an annual declaration without submitting change applications to the HSA. 
• The Ministry of Food and Drug Safety, formerly known as the Korea Food & Drug Administration (KFDA) in South Korea, intends to enforce the Digital Medical Products Act, effective as of January 24, 2025 and establish a regulatory system that reflect the characteristics of digital products (e.g. digital medical devices and pharmaceuticals incorporating digital technologies).  The guidance on the review and approval of SaMD was also updated in January 2025.  The guidance specifies the drafting requirements for regulatory submissions and provides cases on how to make post-market changes as pre-determined.  

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