February 11, 2022
Japan’s Ministry of Health, Labor and Welfare (MHLW) has published several new guidelines and clarifications touching on medical device regulatory issues including cybersecurity, remanufactured single-use devices and the Medical Device Single Audit Program (MDSAP). Japanese medical device market registrants should be aware of these new guidelines, as they may affect regulatory compliance.
Guidebook on medical device cybersecurity
First, the MHLW has issued a new guidebook on medical device cybersecurity (link in Japanese) based on cybersecurity guidelines and recommendations from the International Medical Device Regulators Forum (IMDRF). The new guidebook replaces the MHLW’s medical device cybersecurity guidance issued in July 2018, and provides updated coverage of technical requirements including international resistance standards to address cyber attacks and vulnerabilities.
Guidance for remanufactured devices
Second, the MHLW has published new guidance (link in Japanese) along with a Q&A document regarding classification of remanufactured single-use devices. The guidance includes risk management concepts and recommendations for manufacturers of such devices when determining which treatment methods to utilize. The guidance also establishes classification criteria based on a remanufactured single-use device’s degree of invasiveness.
Third, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), which oversees the country’s medical device market, has issued a new checklist (link in Japanese) for use by manufacturers participating in the MDSAP. The checklist enables market applicants to self-confirm whether their MDSAP reports meet Japanese quality management system conformance requirements as part of their registration with the PMDA.