Medical Device Cybersecurity Regulatory Publications

Medical Device Cybersecurity Regulatory Publications

Colin Morgan January 22, 2021 0 Comments

REGULATORY PUBLICATIONS LIST

Over the past few years, a number of Regulatory Authorities across the globe have published materials related to Medical Device Cybersecurity. We’ve been able to track down links to most of the publications we are aware of and are working on obtaining the ones that are missing. If there are any gaps in the list below, please email info@apraciti.com and we’ll make the necessary updates.

This information should enable Product Security teams to more easily find and review regulatory expectations related to Medical Device Cybersecurity.

(Please note, many of the links below take you to a government agencies website. They are not located within the apraciti.com domain)

Country	Regulatory Authority	Document Title	Release Date	Link
Australia	Therapeutic Goods Administration	Medical device cyber security guidance for industry	2019 (July)	https://www.tga.gov.au/publication/medical-device-cyber-security-guidance-industry
Brazil	General Management of Health Products Technology (GGTPS)	Guide 38/2020, Principles and Practices of Cyber Security in Medical Devices	2020 (September)	https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2020/saiba-mais-sobre-ciberseguranca-em-dispositivos-medicos/guia-38.pdf
Canada	Health Canada	Pre‐market Requirements for Medical Device Cybersecurity	2019 (June)	https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/cybersecurity.html
China	National Medical Products Administration (NMPA)	Medical Device Network Security Registration on Technical Review Guidance Principle	2017 (January)
China	National Medical Products Administration (NMPA)	Draft Technical guideline on medical device cybersecurity, Version II	2020 (September)
France	Agency for the Safety of Health Products	Cybersecurity of Medical Devices integrating software during their lifecycle	2019 (July)	https://www.ansm.sante.fr/S-informer/Points-d-information-Points-d-information/L-ANSM-lance-une-consultation-publique-sur-un-projet-de-recommandations-pour-la-cybersecurite-des-dispositifs-medicaux-Point-d-information
Germany	German Institute for Drugs and Medical Devices (BfArM)	Cyber Security Requirements for Network-Connected Medical Devices	2018 (November)	https://www.allianz-fuer-cybersicherheit.de/ACS/DE/_/downloads/BSI-CS/BSI-CS_132E.html?nn=6656412
Japan	Pharmaceutical and Medical Device Agency	Ensuring Cybersecurity of Medical Device: PFSB/ELD/OMDE Notification No. 0428-1	2015 (April)	Japanese Version – https://www.pmda.go.jp/files/000204891.pdf
Japan	Pharmaceutical and Medical Device Agency	Guidance on Ensuring Cybersecurity of Medical Device: PSEHB/MDED-PSD Notification No. 0724-1	2018 (July)	Japanese Version – https://www.pmda.go.jp/files/000225277.pdf
Japan	Pharmaceutical and Medical Device Agency	Recent Trends in Cybersecurity Assurance of Medical Devices No. 373	2020 (June)	https://www.pmda.go.jp/files/000235348.pdf#page=4
Saudi	Saudi Food and Drug Authority	Guidance to Pre-Market Cybersecurity of Medical Devices	2019 (April)	https://www.sfda.gov.sa/ar/medicaldevices/regulations/DocLib/MDS-G38.pdf
Singapore	Health Sciences Authority	Information Technology Standards Council Technical Reference 67: Medical device cybersecurity	2018	https://itsc.imda.gov.sg/standards/singapore-it-standards/
South Korea	South Korean Ministry of Science and ICT	Cyber Security Guide for Smart Medical Service (Link no longer working)	2018 (May)	https://www.msit.go.kr/web/msipContents/contentsView.do?cateId=mssw311&artId=1383336
Taiwan	Ministry of Health and Welfare	Guidance on Management of Cybersecurity in Medical Devices for Manufacturers	2019 (November)	Chinese Version – https://www.fda.gov.tw/tc/includes/GetFile.ashx?id=f637099316577783149
United States	US Food and Drug Administration	Draft Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices	2018 (October)	https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-management-cybersecurity-medical-devices
United States	US Food and Drug Administration	Final Guidance: Postmarket Management of Cybersecurity in Medical Devices	2016 (December)	https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarket-management-cybersecurity-medical-devices
United States	US Food and Drug Administration	Final Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices	2014 (October)	https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-management-cybersecurity-medical-devices-0
United States	US Food and Drug Administration	Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software	2005 (January)	https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-networked-medical-devices-containing-shelf-ots-software
Other	International Medical Device Regulators Forum	IMDRF Principles and Practices for Medical Device Cybersecurity	2020 (April)	http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-200318-pp-mdc-n60.pdf
EU	Medical Device Coordination Group	MDCG 2019-16 Guidande on Cybersecurity for medical devices	2019 (December)	https://ec.europa.eu/docsroom/documents/38924
United States	The Office of the National Coordinator for Health Information Technology (ONC)	Draft Medical Device Manufacturer Internet of Things (IoT) Code of Conduct	2020 (January)	https://www.healthit.gov/topic/international-health-it-collaborations/draft-medical-device-manufacturer-internet-things-iot-code-conduct

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