| 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/ |
| Canada | Health Canada | Pre‐market Requirements for Medical Device Cybersecurity | 2019
(June) | https://www.canada.ca |
| 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-informe
r/Points-d-information-Points-d-inform
ation/L-ANSM-lance-une-consultat
ion-publique-sur-un-projet-de-reco
mmandations-pour-la-cybersecu
rite-des-dispositifs-medicaux-Poi
t-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-cyb
rsicherheit.de/ACS/DE/_/d
ownloads/BSI-CS/BSI-CS_13
2E.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/fil
es/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/a
r/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/regu
latory-information/search
-fda-guidance-documents
/content-premarket-su
bmissions-manageme
nt-cybersecurity-medic
al-devices |
| United States | US Food and Drug Administration | Final Guidance: Postmarket Management of Cybersecurity in Medical Devices | 2016
(December) | https://www.fda.gov/re
gulatory-information/sea
rch-fda-guidance-docume
nts/postmarket-manage
ment-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-informati
on/search-fda-guidance-document
s/content-premarket
-submissions-manage
ment-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/se
arch-fda-guidance-documents/cyberse
curity-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.or
g/docs/imdrf/final/tech
nical/imdrf-tech-2003
18-pp-mdc-n60.pdf |
| EU | Medical Device Coordination Group | MDCG 2019-16 Guidande on Cybersecurity for medical devices | 2019
(December) | https://ec.europa.eu/d
ocsroom/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.heal
thit.gov/topic/international-health-it-collaborations/draft-medical-device-manufacturer-internet-things-iot-code-conduct |
