AAMI TIR57
AAMI TIR57 - Principles for medical device security - risk management
Licensed standard · Official source linked
United States · Canada · Saudi Arabia
Reference library
Standards
Cited standards, laws, and guidance with recorded jurisdiction treatment and access to the official documents.
Full text is available through official document links. IEC, ISO, AAMI, and other licensed standards may require purchase; their copyrighted text is not reproduced here. Summaries and matrix wording are editorial, not the standard’s full text. Unrecorded treatment means unknown, not rejected.
172 of 172 documents · 34 jurisdictions
AAMI TIR57:2016
Not recorded
Licensed standard · Exact document link not recorded
Jurisdiction treatment not recorded
AMAR
Israel Ministry of Health - Medical Devices Division (AMAR)
Document / framework · Official source linked
Israel
ANVISA Cybersecurity Guide
Agência Nacional de Vigilância Sanitária
Document / framework · Official source linked
Brazil
ANVISA RDC 665
ANVISA RDC 665/2022 - Good Manufacturing Practices for medical devices
Document / framework · Official source linked
Brazil
ANVISA RDC 751
ANVISA RDC 751/2022 - Classification, regularization and post-market for medical devices
Document / framework · Official source linked
Brazil
APPI
Japan Act on the Protection of Personal Information
Document / framework · Official source linked
Japan
ASD ISM
Australian Government Information Security Manual
Document / framework · Official source linked
Australia
ASEAN MDD
Not recorded
Document / framework · Exact document link not recorded
Malaysia · Thailand · Indonesia · Vietnam · Philippines
BS EN 81001-5-1
Not recorded
Document / framework · Exact document link not recorded
United Kingdom
BS EN IEC 81001-5-1
Not recorded
Licensed standard · Exact document link not recorded
Jurisdiction treatment not recorded
BS EN IEC 81001-5-1:2022
Not recorded
Licensed standard · Exact document link not recorded
Jurisdiction treatment not recorded
BSSN - National Cyber and Crypto Agency
Ministry of Health (Kemenkes); BPOM for combination products
Document / framework · Official source linked
Indonesia
CCCS ITSP
CCCS ITSP.40.111 - Cryptographic algorithms for unclassified, protected A and protected B information
Document / framework · Official source linked
Canada
CDSCO MDR
Medical Devices Rules 2017 (as amended)
Document / framework · Official source linked
India
CERT-In 2022
CERT-In Directions of 28 April 2022 (6h reporting, 180-day log retention)
Document / framework · Official source linked
India
CERT-In Directions, April 2022
Central Drugs Standard Control Organization
Document / framework · Official source linked
India
CMU Resolution 753 - Technical Regulation on Medical Devices
State Service of Ukraine on Medicines and Drug Control
Document / framework · Official source linked
Ukraine
COFEPRIS Medical Devices
Comisión Federal para la Protección contra Riesgos Sanitarios
Document / framework · Official source linked
Mexico
Complying with medical device cyber security requirements
Therapeutic Goods Administration
Document / framework · Official source linked
Australia
CRYPTREC
CRYPTREC - Japan's list of approved cryptographic techniques
Document / framework · Official source linked
Japan
CSA Singapore Cybersecurity Act
Health Sciences Authority, Medical Devices Cluster
Document / framework · Official source linked
Singapore
Cyber Resilience Act
European Commission, Medical Device Coordination Group (with national Competent Authorities)
Document / framework · Official source linked
European Union
Cybersecurity in Medical Devices: FAQs
U.S. Food and Drug Administration, Center for Devices and Radiological Health
Document / framework · Official source linked
United States
Data Security Law of the PRC
National Medical Products Administration
Document / framework · Official source linked
China
Decree 98/2021/ND-CP
Department of Medical Equipment and Construction, Ministry of Health
Document / framework · Official source linked
Vietnam
Department of Health Abu Dhabi (ADHICS)
Ministry of Health and Prevention; Dubai Health Authority; Department of Health Abu Dhabi
Document / framework · Official source linked
United Arab Emirates
Digital Personal Data Protection Act 2023
Central Drugs Standard Control Organization
Document / framework · Official source linked
India
Disposición 2318/02 ANMAT
Administración Nacional de Medicamentos, Alimentos y Tecnología Médica
Document / framework · Official source linked
Argentina
DMP Medical Devices
Norwegian Medical Products Agency (Direktoratet for medisinske produkter)
Document / framework · Official source linked
Norway
DMPA
Digital Medical Products Act (Republic of Korea), effective Jan 24 2025
Document / framework · Official source linked
South Korea
DPDP Act
Digital Personal Data Protection Act 2023 (India)
Document / framework · Official source linked
India
Dubai Health Authority (DHA ISR)
Ministry of Health and Prevention; Dubai Health Authority; Department of Health Abu Dhabi
Document / framework · Official source linked
United Arab Emirates
EAEU SaMD guidance
Not recorded
Document / framework · Exact document link not recorded
Kazakhstan
EDA - Egyptian Drug Authority
Egyptian Drug Authority
Document / framework · Official source linked
Egypt
EEC Decision 46 - EAEU Medical Device Rules
National Center for Expertise of Medicines and Medical Products
Document / framework · Official source linked
Kazakhstan
EN IEC 62304
Not recorded
Licensed standard · Exact document link not recorded
Jurisdiction treatment not recorded
EN IEC 81001-5-1:2022
Not recorded
Licensed standard · Exact document link not recorded
Jurisdiction treatment not recorded
EN ISO 14971
Not recorded
Licensed standard · Exact document link not recorded
Jurisdiction treatment not recorded
EU CRA
Regulation (EU) 2024/2847 - Cyber Resilience Act (main obligations from 11 Sep 2026, incl. Art. 13 & 14)
Document / framework · Official source linked
European Union · Switzerland
EU MDR
Regulation (EU) 2017/745 on Medical Devices
Document / framework · Official source linked
European Union · Canada · Switzerland · Turkey · Norway · Ukraine
FD&C s524B
FD&C Act s524B (21 USC 360n-2) - Ensuring cybersecurity of devices
Document / framework · Official source linked
United States
FDA 2023 Guidance
Not recorded
Document / framework · Exact document link not recorded
Singapore · Israel · Taiwan · Mexico · United Arab Emirates · South Africa · Colombia · Chile
FDA Cybersecurity Hub (Digital Health CoE)
U.S. Food and Drug Administration, Center for Devices and Radiological Health
Document / framework · Official source linked
United States
FDA Feb 2026
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (Final Guidance, revised Feb 3 2026)
Document / framework · Official source linked
United States
FDA Feb 2026 Final Guidance
Not recorded
Document / framework · Exact document link not recorded
Canada · Saudi Arabia
FDA MDR
21 CFR Part 803 - Medical Device Reporting
Document / framework · Official source linked
United States
FDA Philippines - Draft Guidelines on Medical Device Software (MDSW)
Food and Drug Administration, Philippines, Center for Device Regulation, Radiation Health and Research
Document / framework · Official source linked
Philippines
FDA Philippines (homepage)
Food and Drug Administration, Philippines, Center for Device Regulation, Radiation Health and Research
Document / framework · Official source linked
Philippines
Final Guidance (Feb 3 2026): Cybersecurity in Medical Devices - Quality Management System Considerations and Content of Premarket Submissions
U.S. Food and Drug Administration, Center for Devices and Radiological Health
Document / framework · Official source linked
United States
Final Guidance PDF (Feb 3 2026)
U.S. Food and Drug Administration, Center for Devices and Radiological Health
Document / framework · Official source linked
United States
GB/T 25000
Not recorded
Licensed standard · Exact document link not recorded
Jurisdiction treatment not recorded
GB/T standards
Not recorded
Licensed standard · Exact document link not recorded
China
GDPR
Regulation (EU) 2016/679 - GDPR (Art. 17 erasure, Art. 32 security of processing)
Document / framework · Official source linked
European Union · United Kingdom
GHC Centralized Registration Procedure
Not recorded
Document / framework · Exact document link not recorded
Kuwait
GHTF SG1
Not recorded
Document / framework · Exact document link not recorded
Egypt
Gulf Health Council
Kuwait Drug and Food Control / Ministry of Health (KDFC)
Document / framework · Official source linked
Kuwait
HC Cyber
Health Canada - Pre-market Requirements for Medical Device Cybersecurity
Document / framework · Official source linked
Canada
HSA CE-11
HSA - Regulatory Guidelines for Software Medical Devices - A Life Cycle Approach (formerly CE-11)
Document / framework · Official source linked
Singapore
HSA Regulatory Guidelines for Software Medical Devices
Health Sciences Authority, Medical Devices Cluster
Document / framework · Official source linked
Singapore
IEC 60601-1
Not recorded
Licensed standard · Exact document link not recorded
Jurisdiction treatment not recorded
IEC 62304
Not recorded
Licensed standard · Exact document link not recorded
India · Ukraine · Kazakhstan
IEC 62443
Not recorded
Licensed standard · Exact document link not recorded
Jurisdiction treatment not recorded
IEC 62443-4-1
IEC 62443-4-1 - Secure product development lifecycle requirements
Licensed standard · Official source linked
European Union · Japan
IEC 80001
Not recorded
Licensed standard · Exact document link not recorded
Jurisdiction treatment not recorded
IEC 81001-5-1
IEC 81001-5-1 - Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
Licensed standard · Official source linked
United States · European Union · United Kingdom · Japan · China · Canada · Australia · South Korea · Singapore · Saudi Arabia · Switzerland · Israel · Taiwan · Turkey · Norway
IEC 81001-5-1:2021
Not recorded
Licensed standard · Exact document link not recorded
Jurisdiction treatment not recorded
IMDRF N60
IMDRF/CYBER WG/N60 - Principles and Practices for Medical Device Cybersecurity
Document / framework · Official source linked
United States · European Union · United Kingdom · Japan · China · Canada · Australia · South Korea · Singapore · Brazil · Saudi Arabia · Switzerland · India · Israel · Taiwan · Mexico · United Arab Emirates · South Africa · Malaysia · Thailand · Indonesia · Argentina · New Zealand · Colombia · Chile · Vietnam · Philippines · Egypt · Hong Kong · Kuwait
IMDRF N70
Principles & practices for the cybersecurity of legacy medical devices
Document / framework · Official source linked
United States · European Union · United Kingdom · Japan · China · Canada · Australia · South Korea · Singapore · Brazil · Saudi Arabia · Switzerland · Argentina
IMDRF N73
IMDRF/CYBER WG/N73 - Principles and Practices for Software Bill of Materials for Medical Devices
Document / framework · Official source linked
United States · European Union · United Kingdom · Japan · China · Canada · Australia · South Korea · Singapore · Brazil · Saudi Arabia · Switzerland · Argentina
INCD Guidance Library
Medical Devices Division (AMAR), Israeli Ministry of Health
Document / framework · Official source linked
Israel
INVIMA - Dispositivos Médicos (programa)
Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Document / framework · Official source linked
Colombia
INVIMA - Dispositivos médicos y equipos biomédicos
Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Document / framework · Official source linked
Colombia
ISO 13485
Not recorded
Licensed standard · Exact document link not recorded
United States · Canada · South Korea · Mexico · South Africa · Malaysia · Thailand · Indonesia · Argentina · New Zealand · Colombia · Chile · Vietnam · Philippines · Ukraine · Kazakhstan · Egypt · Hong Kong · Kuwait
ISO 13485 via MDSAP
Not recorded
Licensed standard · Exact document link not recorded
Canada
ISO 13485:2016
Not recorded
Licensed standard · Exact document link not recorded
United States
ISO 14971
Application of risk management to medical devices
Licensed standard · Official source linked
European Union · Brazil · Switzerland · India · Turkey · Norway · Ukraine · Kazakhstan
ISO 27001
Not recorded
Licensed standard · Exact document link not recorded
United Arab Emirates
ISO/IEC 27001
Not recorded
Licensed standard · Exact document link not recorded
Jurisdiction treatment not recorded
ISP
Instituto de Salud Pública de Chile
Document / framework · Official source linked
Chile
Israeli MoH Medical Devices Division
Medical Devices Division (AMAR), Israeli Ministry of Health
Document / framework · Official source linked
Israel
JIS T 81001-5-1
Pharmaceuticals and Medical Devices Agency / Ministry of Health, Labour and Welfare
Licensed standard · Official source linked
Japan
K-GMP
Not recorded
Document / framework · Exact document link not recorded
South Korea
KCMVP
Korea Cryptographic Module Validation Program
Document / framework · Official source linked
South Korea
Kemenkes - Medical Device Registration (InfoAlkes)
Ministry of Health (Kemenkes); BPOM for combination products
Document / framework · Official source linked
Indonesia
Komdigi (formerly Kominfo) - UU PDP authority
Ministry of Health (Kemenkes); BPOM for combination products
Document / framework · Official source linked
Indonesia
Kuwait Ministry of Health - Drug & Food Control
Kuwait Drug and Food Control / Ministry of Health (KDFC)
Document / framework · Official source linked
Kuwait
Law 151/2020 - Personal Data Protection Law
Egyptian Drug Authority
Document / framework · Official source linked
Egypt
Ley 21.541 (Medical Devices)
Instituto de Salud Pública de Chile
Document / framework · Official source linked
Chile
LGPD
Brazil General Data Protection Law (Lei nº 13.709/2018)
Document / framework · Official source linked
Brazil
MDA Guidance Documents
Medical Device Authority, Ministry of Health Malaysia
Document / framework · Official source linked
Malaysia
MDACS Technical References
Medical Device Division, Department of Health
Document / framework · Official source linked
Hong Kong
MDCG 2019-16
MDCG 2019-16 rev.1 - Guidance on Cybersecurity for medical devices
Document / framework · Official source linked
European Union · United Kingdom
MDCG 2019-16 Rev.1 Guidance on Cybersecurity
European Commission, Medical Device Coordination Group (with national Competent Authorities)
Document / framework · Official source linked
European Union
MDSAP
Not recorded
Document / framework · Exact document link not recorded
Australia · Brazil
Medical device cyber security guidance for industry (PDF)
Therapeutic Goods Administration
Document / framework · Official source linked
Australia
Medical Device Division, Department of Health
Medical Device Division, Department of Health
Document / framework · Official source linked
Hong Kong
Medical Devices Ordinance (MedDO)
Swiss Agency for Therapeutic Products
Document / framework · Official source linked
Switzerland
Medical Devices Regulations SOR/98-282
Health Canada, Medical Devices Bureau
Document / framework · Official source linked
Canada
Medical Devices Rules 2017
Central Drugs Standard Control Organization
Document / framework · Official source linked
India
Medsafe Medical Devices
New Zealand Medicines and Medical Devices Safety Authority
Document / framework · Official source linked
New Zealand
Medsafe Safety Communications
New Zealand Medicines and Medical Devices Safety Authority
Document / framework · Official source linked
New Zealand
Mercosur GMP
Not recorded
Document / framework · Exact document link not recorded
Argentina
MFDS Cyber
MFDS - Guidance on Cybersecurity of Medical Devices (2022 revision)
Document / framework · Official source linked
South Korea
MFDS Medical Device Information Portal (eMed)
Ministry of Food and Drug Safety
Document / framework · Official source linked
South Korea
MFDS Medical Devices (English)
Ministry of Food and Drug Safety
Document / framework · Official source linked
South Korea
MHLW Cybersecurity Notification (2023)
Pharmaceuticals and Medical Devices Agency / Ministry of Health, Labour and Welfare
Document / framework · Official source linked
Japan
MHLW MO 169
MHLW Ministerial Ordinance No. 169 - QMS Ordinance (aligned with ISO 13485)
Document / framework · Official source linked
Japan
MHRA 2026
MHRA consultation on future regulation of medical devices in the UK (2026 update)
Document / framework · Official source linked
United Kingdom
MHRA Cyber
MHRA - Medical device stand-alone software including apps & cybersecurity guidance
Document / framework · Official source linked
United Kingdom
MHRA Software & AI as a Medical Device Change Programme
Medicines and Healthcare products Regulatory Agency
Document / framework · Official source linked
United Kingdom
MLPS 2.0
GB/T 22239-2019 - Multi-Level Protection Scheme 2.0 baseline requirements
Document / framework · Official source linked
China
MoHAP
UAE Ministry of Health and Prevention - Medical Devices
Document / framework · Official source linked
United Arab Emirates
MOHAP Digital Security
Ministry of Health and Prevention; Dubai Health Authority; Department of Health Abu Dhabi
Document / framework · Official source linked
United Arab Emirates
NCA ECC
Saudi NCA Essential Cybersecurity Controls
Document / framework · Official source linked
Saudi Arabia
NCEMP - National Center for Expertise
National Center for Expertise of Medicines and Medical Products
Document / framework · Official source linked
Kazakhstan
NCSC CAF
Not recorded
Document / framework · Exact document link not recorded
United Kingdom
NCSC Crypto
NCSC guidance - Using cryptography for products and services
Document / framework · Official source linked
United Kingdom
NCSC Vulnerability Disclosure Toolkit
Medicines and Healthcare products Regulatory Agency
Document / framework · Official source linked
United Kingdom
NHS Digital Technology Assessment Criteria (DTAC)
Medicines and Healthcare products Regulatory Agency
Document / framework · Official source linked
United Kingdom
NIS2
Directive (EU) 2022/2555 (NIS2) - reporting clocks for essential entities
Document / framework · Official source linked
European Union
NIST CSF
Not recorded
Document / framework · Exact document link not recorded
United Arab Emirates
NIST SP 800-30
Not recorded
Document / framework · Exact document link not recorded
United States
NIST SP 800-88
Not recorded
Document / framework · Exact document link not recorded
Jurisdiction treatment not recorded
NMPA 2022
NMPA Technical Guiding Principles for Cybersecurity Registration Review of Medical Devices (2022 revision)
Document / framework · Official source linked
China
NMPA Cybersecurity Guideline (2022)
National Medical Products Administration
Document / framework · Official source linked
China
NOM-241-SSA1-2021
Comisión Federal para la Protección contra Riesgos Sanitarios
Document / framework · Official source linked
Mexico
OSCCA
PRC Cryptography Law (SM2/SM3/SM4 commercial cryptography rules)
Document / framework · Official source linked
China
PDPA (SG)
Singapore Personal Data Protection Act 2012
Document / framework · Official source linked
Singapore · Taiwan
PDPA (TW)
Taiwan Personal Data Protection Act
Document / framework · Official source linked
Jurisdiction treatment not recorded
PDPD 2023, Personal Data Protection Decree
Department of Medical Equipment and Construction, Ministry of Health
Document / framework · Official source linked
Vietnam
PDPL (SA)
Saudi Personal Data Protection Law
Document / framework · Official source linked
Saudi Arabia
PIPA (KR)
Personal Information Protection Act (Republic of Korea)
Document / framework · Official source linked
South Korea
PIPEDA
Personal Information Protection and Electronic Documents Act
Document / framework · Official source linked
Canada
PIPL
PRC Personal Information Protection Law (2021)
Document / framework · Official source linked
China
PIPL, Personal Information Protection Law
National Medical Products Administration
Document / framework · Official source linked
China
PMDA Cyber
PMDA - Medical device cybersecurity resources (MHLW Notification 0324-11 and follow-ons)
Document / framework · Official source linked
Japan
PMDA Medical Device Cybersecurity Page
Pharmaceuticals and Medical Devices Agency / Ministry of Health, Labour and Welfare
Document / framework · Official source linked
Japan
POPIA
South African Health Products Regulatory Authority
Document / framework · Official source linked
South Africa
Postmarket Management of Cybersecurity in Medical Devices
U.S. Food and Drug Administration, Center for Devices and Radiological Health
Document / framework · Official source linked
United States
PRC Cyber Law
PRC Cybersecurity Law (2017)
Document / framework · Official source linked
China
PRC DSL
PRC Data Security Law (2021)
Document / framework · Official source linked
China
Pre-market Requirements for Medical Device Cybersecurity (Health Canada)
Health Canada, Medical Devices Bureau
Document / framework · Official source linked
Canada
QMSR
21 CFR Part 820 - Quality Management System Regulation (aligned to ISO 13485:2016), effective Feb 2 2026
Document / framework · Official source linked
United States
Quality Management System Regulation (21 CFR Part 820, effective Feb 2 2026)
U.S. Food and Drug Administration, Center for Devices and Radiological Health
Document / framework · Official source linked
United States
RDC 751/2022
Agência Nacional de Vigilância Sanitária
Document / framework · Official source linked
Brazil
Regulation (EU) 2017/745, MDR
European Commission, Medical Device Coordination Group (with national Competent Authorities)
Document / framework · Official source linked
European Union
revFADP
Swiss Federal Act on Data Protection (revised, in force Sep 2023)
Document / framework · Official source linked
Switzerland
RMSV
Regulations on the Management of Security Vulnerabilities of Network Products (2021, 48h CNCERT reporting)
Document / framework · Official source linked
China
SAHPRA Medical Devices
South African Health Products Regulatory Authority
Document / framework · Official source linked
South Africa
SES - State Service of Ukraine on Medicines and Drug Control
State Service of Ukraine on Medicines and Drug Control
Document / framework · Official source linked
Ukraine
SFDA MDS-G027 Guidance on Digital Health Products (Aug 2025)
Saudi Food and Drug Authority
Document / framework · Official source linked
Saudi Arabia
SFDA MDS-G34
SFDA MDS-G34 - Guidance on Medical Device Cybersecurity
Document / framework · Official source linked
Saudi Arabia
SFDA Medical Devices Regulations Hub
Saudi Food and Drug Authority
Document / framework · Official source linked
Saudi Arabia
SN EN IEC 81001-5-1:2022
Not recorded
Licensed standard · Exact document link not recorded
Jurisdiction treatment not recorded
SOCI Act
Security of Critical Infrastructure Act 2018 (Cth)
Document / framework · Official source linked
Australia
Swissmedic MD
Swissmedic - Medical devices (MedDO / MDR alignment)
Document / framework · Official source linked
Switzerland
Swissmedic Medical Devices
Swiss Agency for Therapeutic Products
Document / framework · Official source linked
Switzerland
TFDA Cyber
TFDA - Guidance on Medical Device Cybersecurity (2021)
Document / framework · Official source linked
Taiwan
TFDA Medical Device Cybersecurity Guidance
Taiwan Food and Drug Administration
Document / framework · Official source linked
Taiwan
TGA Cyber
TGA - Medical device cyber security guidance for industry
Document / framework · Official source linked
Australia
TGA Guidance
Not recorded
Document / framework · Exact document link not recorded
New Zealand
TGA medical device cyber security hub
Therapeutic Goods Administration
Document / framework · Official source linked
Australia
Thai FDA - Software as a Medical Device (SaMD) registration
Food and Drug Administration, Thailand, Medical Device Control Division
Document / framework · Official source linked
Thailand
Thai FDA Medical Device Control Division
Food and Drug Administration, Thailand, Medical Device Control Division
Document / framework · Official source linked
Thailand
TİTCK Medical Devices
Turkish Medicines and Medical Devices Agency
Document / framework · Official source linked
Turkey
UK GDPR
Data Protection Act 2018 / UK GDPR
Document / framework · Official source linked
United Kingdom
UL 2900-1
Not recorded
Licensed standard · Exact document link not recorded
Jurisdiction treatment not recorded
UL 2900-2-1
Not recorded
Licensed standard · Exact document link not recorded
United States
ÜTS, Product Tracking System
Turkish Medicines and Medical Devices Agency
Document / framework · Official source linked
Turkey
WAND Database (Web-Assisted Notification of Devices)
New Zealand Medicines and Medical Devices Safety Authority
Document / framework · Official source linked
New Zealand
YY/T 0316
Not recorded
Licensed standard · Exact document link not recorded
Jurisdiction treatment not recorded