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Medical Device Cybersecurity Regulatory Publications

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
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 China Food and Drug Administration Medical Device Network Security Registration on Technical Review Guidance Principle 2017
(January)
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 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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