Medical & Healthcare — 348 Nodes
- 10 CFR Part 35 - NRC Medical Use of Byproduct Material
10 CFR Part 35 governs the medical use of byproduct material (radioactive material) administered by the U.S. Nuclear Regulatory Commission and Agreement States. A person must hold a specific license before receiving,… - 18 U.S.C. 1035 - False Statements Relating to Health Care Matters
18 U.S.C. 1035 makes it an offence to knowingly and willfully, in any matter involving a health care benefit program, falsify, conceal or cover up by any trick, scheme or device a material fact (subsection (a)(1)), or… - 21 CFR Part 11 - Electronic Records; Electronic Signatures
This regulation establishes the US Food and Drug Administration (FDA) criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and… - 21 CFR Part 1271 - Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
FDA 21 CFR Part 1271 governs human cells, tissues, and cellular and tissue-based products, setting the criteria under which an HCT/P is regulated solely under section 361 of the Public Health Service Act, requiring… - 21 CFR Part 16 - FDA Regulatory Hearing Procedure (Pre-Decision Hearings, Notices of Opportunity, Presiding Officer, Administrative Decision, Judicial Review)
21 CFR Part 16 sets the procedural framework for the FDA regulatory hearing - the agency's pre-decision hearing mechanism used either at the Commissioner's discretion to obtain additional information before making a… - 21 CFR Part 25 - FDA Environmental Impact Considerations (NEPA Implementation: Environmental Assessments, Categorical Exclusions, Environmental Impact Statements)
21 CFR Part 25 sets the FDA implementation of the National Environmental Policy Act of 1969 (NEPA) section 102(2) for FDA actions affecting FDA-regulated products including drugs, biologics, medical devices, tobacco… - 21 CFR Part 312 - Investigational New Drug Application
This regulation requires sponsors to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) before initiating any clinical investigation of a new drug in human subjects. As… - 21 CFR Part 314: Applications for FDA Approval to Market a New Drug
This regulation establishes the comprehensive requirements for submitting a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval. It mandates specific content and format for… - 21 CFR Part 4 - FDA Combination Products cGMP and Postmarketing Safety Reporting
21 CFR Part 4 sets the current good manufacturing practice (cGMP) requirements and postmarketing safety reporting requirements for combination products regulated by the U.S. Food and Drug Administration. A combination… - 21 CFR Part 50 - Protection of Human Subjects
Organizations conducting clinical investigations involving human subjects must obtain and document informed consent, adhering to specific required elements and implementing additional safeguards for vulnerable… - 21 CFR Part 54 - Financial Disclosure by Clinical Investigators
21 CFR Part 54 requires an applicant who submits a marketing application for a human drug, biological product or device, relying on covered clinical studies, to disclose or certify certain financial interests and… - 21 CFR Part 58 - Good Laboratory Practice for Nonclinical Laboratory Studies
This regulation establishes the minimum standards for the conduct of nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the… - 21 CFR Part 606 - Current Good Manufacturing Practice for Blood and Blood Components
21 CFR Part 606 establishes the current good manufacturing practice (CGMP) requirements for the collection, processing, compatibility testing, storage and distribution of blood and blood components for transfusion or… - 21 CFR Part 7 - Enforcement Policy: Recalls (Product Corrections), Health Hazard Evaluation, Recall Classification, and Industry Responsibilities
21 CFR Part 7 sets the FDA enforcement policy framework for recalls of FDA-regulated products and codifies the recall guidance for industry, health-hazard evaluation, recall classification, recall strategy,… - 21 CFR Part 801 - Medical Device Labeling
21 CFR Part 801 sets out the FDA labeling requirements for medical devices. The label of a device in package form must conspicuously specify the name and place of business of the manufacturer, packer or distributor,… - 21 CFR Part 803 - Medical Device Reporting
This regulation establishes mandatory requirements for manufacturers, importers, and user facilities of medical devices to report certain device-related adverse events and product problems to the FDA. - 21 CFR Part 803 - Medical Device Reporting
This regulation establishes requirements for medical device user facilities, importers, and manufacturers to report adverse events and other device-related problems to the FDA. - 21 CFR Part 807 - Device Establishment Registration, Device Listing and 510(k) Premarket Notification
21 CFR Part 807 requires owners and operators of establishments engaged in the manufacture, preparation, propagation, compounding, assembly or processing of devices intended for human use to register their… - 21 CFR Part 808 - Exemptions from Federal Preemption of State and Local Medical Device Requirements (FDA Section 521 Petitions)
21 CFR Part 808 prescribes the procedures by which a State or political subdivision may apply to the U.S. Food and Drug Administration for an exemption from the Federal preemption of State and local requirements… - 21 CFR Part 812 - Investigational Device Exemptions (IDE)
21 CFR Part 812 sets out the FDA Investigational Device Exemption (IDE) requirements that permit a device that would otherwise require marketing clearance or approval to be shipped lawfully for the purpose of conducting… - 21 CFR Part 814 Subpart H - Humanitarian Use Devices (HUDs) and Humanitarian Device Exemption (HDE) Pathway for Rare Disease and Pediatric Subpopulation Medical Devices
21 CFR Part 814 Subpart H implements section 515A and section 520(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and creates the Humanitarian Device Exemption (HDE) marketing pathway for devices intended to… - 21 CFR Part 820 - Quality Management System Regulation
Manufacturers of medical devices must establish, document, and maintain a quality management system (QMS) that complies with ISO 13485 and specific FDA requirements for record control, labeling, and packaging. - 21 CFR Part 821 - Medical Device Tracking Requirements (FDA Tracking Orders for Class II and Class III Devices)
21 CFR Part 821 implements section 519(e) of the Federal Food, Drug, and Cosmetic Act and prescribes the FDA medical device tracking regime applicable to Class II or Class III devices where a failure of the device would… - 21 CFR Part 830 - FDA Unique Device Identification (UDI)
21 CFR Part 830 establishes the unique device identification (UDI) system administered by the U.S. Food and Drug Administration. A labeler of a medical device that is required to bear a unique device identifier must… - 21 CFR Part 99 - Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices (FDA Off-Label Information Regime)
21 CFR Part 99 governs the dissemination by a manufacturer of written information on a use of an approved or cleared drug, biologic, or device that is not included in the FDA-approved labeling or the cleared statement… - 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program (45 CFR Parts 170 and 171)
This regulation prohibits practices likely to interfere with, prevent, or materially discourage the access, exchange, or use of electronic health information (EHI) by healthcare providers, health IT developers, and… - 3D-Printed / Additively Manufactured Medical Devices - Regulatory & Quality Requirements (2026)
Additively manufactured (3D-printed) medical devices require specific regulatory controls covering design validation, material qualification, process validation, post-processing, sterility assurance, and… - 42 CFR Part 1001 - HHS OIG Exclusions from Federal Health Care Programs
42 CFR Part 1001 governs the exclusion of individuals and entities from participation in Medicare, Medicaid and other Federal health care programs by the U.S. Department of Health and Human Services Office of Inspector… - 42 CFR Part 2 - Confidentiality of Substance Use Disorder Patient Records (2024 Final Rule)
This regulation modifies the confidentiality rules for substance use disorder (SUD) patient records from federally assisted programs, primarily by permitting a single patient consent for all future uses and disclosures… - 42 CFR Part 2: Confidentiality of Substance Use Disorder Patient Records
This regulation establishes strict confidentiality requirements for patient records related to substance use disorder treatment from federally assisted programs, governing how and when patient-identifying information… - 42 CFR Part 411 - CMS Medicare Secondary Payer Rules and Recovery
42 CFR Part 411 implements the Medicare Secondary Payer (MSP) rules administered by the U.S. Centers for Medicare & Medicaid Services, and sets out certain exclusions from Medicare coverage. Where another payer is… - 42 CFR Part 431 - State Organization and General Administration
This regulation requires U.S. states to establish a single state agency to administer their Medicaid plan, ensuring statewide operation, beneficiary rights like free provider choice and fair hearings, and maintaining… - 42 CFR Part 482 - Conditions of Participation for Hospitals
Hospitals participating in Medicare and Medicaid must meet specific conditions related to administration, basic functions, patient rights, and emergency preparedness to ensure patient health and safety. - 42 CFR Part 485 - Conditions of Participation: Specialized Providers
Specialized providers, including Comprehensive Outpatient Rehabilitation Facilities and Rural Emergency Hospitals, must comply with specific conditions of participation covering governance, services, staffing, physical… - 42 CFR Part 488 - Survey, Certification, and Enforcement Procedures
This regulation establishes the procedures for survey, certification, and enforcement for healthcare providers and suppliers participating in Medicare and Medicaid, including requirements for state survey agencies and… - 42 CFR Part 493 - Laboratory Requirements
This regulation establishes federal quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results, regardless of where the test is performed. - 45 CFR 164.308 - Administrative safeguards
A covered entity or business associate must implement administrative safeguards, including policies, procedures, and risk management processes, to protect the confidentiality, integrity, and availability of electronic… - 45 CFR 164.310 - Physical safeguards.
Organizations must implement policies, procedures, and physical safeguards to control facility access, secure workstations, and manage electronic devices and media containing protected health information. - 45 CFR 164.312 - Technical safeguards.
Organizations must implement technical policies and procedures, including access controls, audit controls, integrity measures, authentication, and transmission security, to protect electronic protected health… - 45 CFR 164.314 - Organizational requirements.
This regulation requires covered entities and group health plans to establish contracts or amend plan documents to ensure their business associates and plan sponsors appropriately safeguard electronic protected health… - 45 CFR 164.316 - Policies and procedures and documentation requirements.
Covered entities and business associates must implement and maintain written policies and procedures to comply with HIPAA Security Rule standards, and retain all required documentation for six years. - 45 CFR 164.404 - Notification to individuals.
This regulation requires covered entities to notify individuals whose unsecured protected health information has been breached without unreasonable delay and no later than 60 days after discovery, specifying the content… - 45 CFR 164.410 - Notification by a business associate.
This regulation requires a business associate to provide notification to a covered entity following the discovery of a breach of unsecured protected health information. - 45 CFR 164.502 -- Uses and disclosures of protected health information: General rules.
This regulation establishes the general principle that a covered entity or business associate may not use or disclose protected health information (PHI) except as explicitly permitted or required by law, and mandates… - 45 CFR 164.524 - Access of individuals to protected health information
This regulation establishes an individual's right to access, inspect, and obtain a copy of their protected health information (PHI) held by a covered entity, and sets requirements for the timely provision or denial of… - 45 CFR 164.530 - Administrative requirements
This regulation requires covered entities to implement a set of administrative measures to protect health information, including designating a privacy official, training staff, establishing safeguards, and maintaining… - 45 CFR Part 162 - Administrative Requirements
This regulation establishes requirements for covered entities to use standard unique identifiers, code sets, and transaction formats for administrative and financial healthcare transactions to simplify processes and… - 45 CFR Part 162 - HIPAA Administrative Simplification: Standard Unique Identifiers
HHS 45 CFR Part 162 implements the HIPAA Administrative Simplification standard unique identifiers and electronic transaction standards, requiring covered entities to obtain and use the National Provider Identifier for… - 45 CFR Part 164 - Security and Privacy
Organizations must implement administrative, physical, and technical safeguards to protect electronic protected health information (ePHI) and provide notifications to individuals, the media, and the Secretary in the… - 45 CFR Part 171 - ONC Information Blocking and Exceptions
45 CFR Part 171 implements the information blocking provisions of the 21st Century Cures Act administered by the Office of the National Coordinator for Health Information Technology. An actor (a health care provider,… - Adversarial Robustness & Cybersecurity for Health AI Systems (2026)
Specialized cybersecurity framework addressing vulnerabilities unique to AI in healthcare, such as adversarial attacks (pixel perturbations altering diagnoses), data poisoning, and model inversion. It mandates… - AI in Radiology & Medical Imaging - Governance, Validation & Clinical Use (2026)
Clinical governance framework for the deployment and ongoing use of Artificial Intelligence in radiology and medical imaging. It addresses algorithmic bias, continuous monitoring for model drift, physician-in-the-loop… - AI Signal Detection in Pharmacovigilance - FDA/EMA Best Practices 2026
Detailed framework for validation, qualification, and ongoing performance monitoring of AI/ML systems used for adverse event signal detection, case processing, and aggregate reporting. - AI-Enabled Pharmacovigilance Systems - Global Governance & Validation Requirements (2026)
AI systems used for signal detection, adverse event processing, literature monitoring, and risk assessment in pharmacovigilance must meet stringent validation, explainability, bias mitigation, human oversight, and… - AI/ML Model Lifecycle Management in Healthcare (2026)
Total Product Lifecycle (TPLC) management for AI/ML-based Medical Devices, incorporating Good Machine Learning Practice (GMLP). It covers requirements for continuous post-market surveillance, algorithmic bias… - Argentina ANMAT Medical Device Registration - Disposicion ANMAT 2318/2002 (Mercosur Technical Regulation) and amendments, with Authorized Local Representative requirement
ANMAT requires medical devices to be registered before commercialisation in Argentina under Disposicion ANMAT 2318/2002 (the Mercosur technical regulation for registration of medical products) and its amendments.… - Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan
This Action Plan outlines the U.S. Food and Drug Administration's (FDA) multi-pronged approach to advance its oversight of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD).… - Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan
This Action Plan from the U.S. Food & Drug Administration (FDA) outlines a five-part strategy to regulate Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD). Developed in response… - Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan
This action plan outlines the FDA's multi-pronged approach to regulating AI/ML-based Software as a Medical Device (SaMD), focusing on a total product lifecycle framework that includes a Predetermined Change Control Plan… - AU Therapeutic Goods Act 1989 (TGA) - Medical Device Conformity Assessment and ARTG Inclusion
The Therapeutic Goods Administration (TGA) regulates medical devices in Australia under the Therapeutic Goods Act 1989 and Therapeutic Goods (Medical Devices) Regulations 2002. Devices must be included in the Australian… - Australia My Health Records Act 2012 - National Digital Health Record System
The My Health Records Act 2012 (Commonwealth, Act No. 63 of 2012) establishes Australia's national digital health record system administered by the Australian Digital Health Agency as System Operator under the… - Australia TGA - Therapeutic Goods (Medical Devices) Regulations 2002 (2026 Reforms)
The Therapeutic Goods Administration (TGA) regulates medical devices and SaMD under the Therapeutic Goods Act 1989 and Regulations 2002. 2026 reforms introduce strengthened cybersecurity requirements, AI-specific… - Australia Therapeutic Goods Act 1989 -- TGA Registration, Medical Device Conformity, and Advertising
The Therapeutic Goods Act 1989 (TGA Act) establishes the Therapeutic Goods Administration (TGA) as Australia's regulator for medicines, medical devices, biologicals, and other therapeutic goods. No person may supply… - Ayushman Bharat Digital Mission (ABDM) 2021 - Health ID (ABHA Number), Health Facility Registry (HFR), Healthcare Professionals Registry (HPR), Unified Health Interface (UHI), Personal Health Records (PHR) Linked Consent Manager and ABDM Sandbox API Gateway
The ABDM 2021 framework establishes a national digital health ecosystem in India requiring all healthcare providers, facilities, and technology systems to register with designated ABDM registries and comply with data… - Blockchain for Health Data Interoperability & Patient-Controlled Records (2026)
Blockchain and distributed ledger technologies enable secure, patient-controlled health records with verifiable provenance, immutable audit trails, and selective disclosure. Governance must address data privacy… - CA Health Canada Medical Devices Regulations SOR/98-282 - Licence and Safety Requirements
Health Canada regulates medical devices in Canada under the Medical Devices Regulations (SOR/98-282) made under the Food and Drugs Act. Class II, III, and IV devices require a Medical Device Licence (MDL) from Health… - California Assembly Bill 3030 - Health Care Services: Artificial Intelligence (Approved 28 September 2024) - Mandatory Generative AI Disclaimer for Patient Clinical Communications by Health Facilities, Clinics, Physician Offices, and Group Practices; Codified as Health and Safety Code Section 1339.75
California Assembly Bill 3030, approved by Governor Newsom on 28 September 2024, adds Chapter 2.13 (commencing with Section 1339.75) to Division 2 of the California Health and Safety Code, requiring any health facility,… - California Confidentiality of Medical Information Act (CMIA) - Civil Code §§ 56-56.245 (2026)
The CMIA provides California-specific protections for medical information beyond HIPAA. It imposes strict consent requirements for disclosure, prohibits sale of medical information, requires breach notification within… - California Senate Bill 1120 (Becker) - Physicians Make Decisions Act, Health Care Coverage: Utilization Review (2024) - Restrictions on AI, Algorithm, and Software Tool Use in Utilization Review by Health Care Service Plans and Disability Insurers; Amendments to Health and Safety Code Section 1367.01 and Insurance Code Section 10123.135
California Senate Bill 1120 (Becker), the Physicians Make Decisions Act, amends Section 1367.01 of the California Health and Safety Code (governing health care service plans regulated by the Department of Managed Health… - Canada Controlled Drugs and Substances Act - Scheduling, Possession, Trafficking and Production Offences
Canada's Controlled Drugs and Substances Act (S.C. 1996, c. 19) controls substances listed in Schedules I to IX. Section 4(1) prohibits possession of a substance included in Schedule I, II or III; section 5(1) prohibits… - Canada Health Act 1984 (R.S.C. 1985, c. C-6) - National Health Insurance Criteria
The Canada Health Act (R.S.C. 1985, c. C-6) establishes the federal criteria and conditions that provincial and territorial health insurance plans must satisfy to receive full federal cash contributions under the Canada… - Canada PHIPA / PIPEDA - Health Information Protection (Ontario & Federal Alignment 2026)
Ontario’s Personal Health Information Protection Act (PHIPA) and federal PIPEDA govern health information. Key obligations include consent, safeguards, breach notification (to affected individuals and OPC within 30… - Canada Quarantine Act - Communicable Disease Controls at Points of Entry
Canada's Quarantine Act (S.C. 2005, c. 20) aims to prevent the introduction and spread of communicable diseases. Section 15(2) requires a traveller who has reasonable grounds to suspect they have a listed communicable… - Canada Tobacco and Vaping Products Act - Youth Access, Promotion, Labelling and Penalties
Canada's Tobacco and Vaping Products Act (S.C. 1997, c. 13) regulates the manufacture, sale, labelling and promotion of tobacco and vaping products. Section 8(1) prohibits furnishing a tobacco or vaping product to a… - Care Act 2014 Section 9: Needs assessment
Local authorities must conduct a needs assessment for any adult who appears to have needs for care and support, involving the adult and their carer, and considering specific factors like well-being, desired outcomes,… - China NMPA - Regulation on AI Medical Devices and SaMD (2026)
The National Medical Products Administration (NMPA) regulates AI-enabled medical devices and Software as a Medical Device under the Medical Device Regulation and specific AI guidelines. Requirements include… - Clinical Decision Support (CDS) AI Systems - Global Governance & Regulatory Obligations (2026)
AI-powered Clinical Decision Support systems are subject to stringent oversight when they influence diagnosis, treatment, or patient management. Requirements include rigorous clinical validation,… - CMS Advancing Interoperability and Improving Prior Authorization Processes Final Rule (CMS-0057-F)
This rule requires impacted payers (Medicare Advantage, Medicaid, CHIP, and QHP issuers) to implement and maintain specific FHIR-based APIs to improve patient data exchange and automate prior authorization processes.… - Combination Products (Drug-Device) - Regulatory Governance & Lifecycle Requirements (2026)
Combination products (e.g., drug-eluting stents, prefilled syringes, digital therapeutics with drug components) require coordinated regulatory oversight under primary mode of action (PMOA). Manufacturers must comply… - Commission Decision (EU) 2025/2371 of 26 November 2025 on the notice regarding the functionality and the fulfilment of the functional specifications of certain electronic systems included in the European Database on Medical Devices (EUDAMED) referred to in Article 34(1) of Regulation (EU) 2017/745
This Commission Decision confirms that four EUDAMED electronic systems (registration of economic operators, UDI/device registration, notified bodies and certificates, and market surveillance) have achieved functionality… - Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products
This regulation establishes the procedures and conditions for managing post-approval changes (variations) to marketing authorisations for medicinal products in the EU, classifying them as minor (Type IA/IB), major (Type… - Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council
This regulation establishes a framework for granting conditional marketing authorisation (CMA) to medicinal products that address an unmet medical need, based on a positive risk-benefit balance with less than… - Companion Diagnostics (CDx) - IVDR & Global Regulatory Requirements (2026)
Regulatory framework governing Companion Diagnostics (CDx) under the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746. It addresses the co-development of drugs and CDx, requiring Notified Body… - Connected Health Ecosystems & IoMT Security Framework (2026)
Comprehensive cybersecurity architecture for the Internet of Medical Things (IoMT) and connected health ecosystems. It addresses the vulnerabilities introduced when legacy medical devices, consumer wearables, and cloud… - Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) - Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases
This guidance document describes one part of FDA’s efforts to create a flexible and adaptive regulatory approach to the oversight of next generation sequencing (NGS)-based tests. As a step toward this vision, FDA is… - Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products
Mandated by the 21st Century Cures Act, Section 505F, this FDA framework outlines requirements for sponsors using Real-World Data (RWD) and Real-World Evidence (RWE) in regulatory submissions, demanding that data be… - Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions
With the increasing integration of wireless, Internet- and network-connected capabilities, the need for robust cybersecurity controls to ensure medical device safety and effectiveness has become more important.… - Cybersecurity of Genomic Data
This report describes current practices in cybersecurity and privacy risk management for protecting genomic data. Genomic data's unique characteristics, such as being immutable and containing information about kinship… - DICOM Imaging Standard
DICOM (Digital Imaging and Communications in Medicine) is the international standard for medical imaging and related information. It specifies the network protocols for image exchange (PACS/RIS integration), the media… - Digital Therapeutics (DTx) - Regulatory Classification & Market Access (2026)
Digital Therapeutics are software-driven interventions that deliver evidence-based therapeutic treatments for medical conditions. They are regulated as medical devices (often SaMD) in most jurisdictions, requiring… - Digital Therapeutics (DTx) - US FDA Software as a Medical Device (SaMD) Regulatory Pathway, Quality System and Post-Market Surveillance
There is no single binding instrument titled the 'Digital Therapeutics (DTx) Regulatory Framework - FDA, EMA and Global Convergence 2026'. Prescription digital therapeutics are regulated in the United States as Software… - Directive (EU) 2022/2555 (NIS2) - Cybersecurity Requirements for Health Sector Entities (2026)
NIS2 Directive classifies hospitals, clinics, manufacturers of critical medical devices, and other health entities as essential or important entities. It mandates comprehensive cybersecurity risk management, incident… - Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (Consolidated)
This directive establishes the comprehensive EU regulatory framework for medicinal products for human use, mandating that no product can be placed on the market without a valid Marketing Authorisation (Article 6). It… - Directive 2011/62/EU amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products - Article 54a
Organizations must place safety features, including a unique identifier and an anti-tampering device, on the packaging of most prescription medicinal products and certain high-risk non-prescription medicinal products to… - Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products
Directive 2011/62/EU mandates that prescription medicines bear safety features, specifically a unique identifier (UI) in a 2D barcode and an anti-tampering device (ATD), to prevent falsified products from entering the… - Drug Supply Chain Security Act (DSCSA) - Enhanced Drug Distribution Security Requirements for Interoperable, Electronic Tracing of Products at the Package Level
The DSCSA requires all pharmaceutical trading partners to implement a fully electronic, interoperable system to trace and verify prescription drugs at the individual package level throughout the U.S. supply chain. As… - Ethics and Governance of Artificial Intelligence for Health
This World Health Organization guidance establishes six core principles for the ethical design, deployment, and governance of AI in the health sector, applicable to developers, regulators, and healthcare providers. It… - EU AI Act - High-Risk AI Systems in Medical Devices & Healthcare (2026)
Under the EU AI Act, most AI systems used in medical devices, clinical decision support, patient risk assessment, and biometric categorization are classified as high-risk. Providers must comply with strict obligations… - EU Clinical Trials Information System (CTIS) Under CTR 536/2014 - Centralised Submission Portal, Transparency Publication Rules and Multi-Member State Trial Coordination and Assessment
The Clinical Trials Information System (CTIS) is the mandatory single entry point for sponsors and regulators to submit, assess, and supervise clinical trials in the European Economic Area (EEA) under Regulation (EU) No… - EU In Vitro Diagnostics Regulation 2017/746 -- IVD Classification, Performance Evaluation, and Market Authorisation
Regulation (EU) 2017/746 (IVDR) replaces Directive 98/79/EC and establishes a stricter classification and conformity assessment framework for in vitro diagnostic medical devices placed on the EU market. IVDR applied… - EU IVDR 2017/746 (Diagnostics)
EU Regulation 2017/746 (In-Vitro Diagnostic Medical Device Regulation - IVDR) is the primary framework for diagnostic devices in the European Union. It replaces the previous 98/79/EC directive and dramatically increases… - EU MDR 2017/745 (Devices)
EU Regulation 2017/745 (Medical Device Regulation - MDR) is the primary framework for medical device compliance in the European Union. It replaces the previous MDD/AIMDD directives, introducing more rigorous… - EU MDR Annex II & III - Technical Documentation Requirements (2026)
Comprehensive requirements for compiling the Technical Documentation (TD) file required to demonstrate a medical device conforms to the General Safety and Performance Requirements (GSPR) under the EU MDR. Annex II… - EU MDR Annex IX - Conformity Assessment Procedures for High-Risk Devices
Detailed procedures for Class IIb and III devices including QMS audits, technical documentation review, and clinical evaluation consultation. 2026 amendments strengthen scrutiny for AI/ML components under Rule 11. - EU MDR Annex XIV - Clinical Evaluation and Post-Market Clinical Follow-up
Requirements for clinical evaluation plans, clinical investigations, and continuous post-market clinical follow-up (PMCF). 2026 updates strengthen requirements for AI/ML devices and real-world evidence usage. - EU MDR Annex XIV - Clinical Investigation Requirements for Medical Devices (2026)
Legal framework under Annex XIV of the EU Medical Device Regulation (MDR) governing how clinical investigations must be designed, authorized, and conducted to demonstrate the safety and clinical performance of medical… - EU MDR Annex XVI - Products Without Intended Medical Purpose
Requirements for aesthetic devices, wellness products, and other non-medical purpose items that fall under MDR scope. 2026 clarifications address AI-enabled wellness tools and common specifications. - EU MDR Article 61 - Clinical Evaluation Requirements (2026)
Under the EU Medical Device Regulation (MDR) 2017/745, Article 61 dictates that clinical evaluation must be a continuous process throughout the lifecycle of a medical device. It mandates that manufacturers… - EU MDR Clinical Evaluation & Clinical Investigation Requirements (2026)
Strict requirements under the EU Medical Device Regulation (MDR) for conducting clinical evaluations. It mandates a continuous, methodologically sound process to collect, appraise, and analyze clinical data to verify… - EU MDR Post-Market Clinical Follow-up (PMCF) - Detailed Requirements (2026)
PMCF under the EU MDR is a continuous, proactive process to collect and evaluate clinical data from the use of a CE-marked device. It confirms the safety and performance throughout the device's expected lifetime,… - EU Medical Device Regulation 2017/745 - Conformity Assessment and Post-Market Surveillance
Regulation (EU) 2017/745 (MDR) replaces the Medical Devices Directive 93/42/EEC and imposes stricter requirements for medical device conformity assessment, clinical evaluation, unique device identification (UDI), and… - EU Medical Devices Regulation (MDR) 2017/745 -- CE Marking and Market Surveillance for Medical Devices
Regulation (EU) 2017/745 (MDR) governs the placing on the EU market of medical devices and accessories. It replaced MDD 93/42/EEC and AIMD 90/385/EEC and applied fully from 26 May 2021 (with extended transition periods… - EU Medical Devices Regulation 2017/745 - CE Marking, Clinical Evaluation & Post-Market Surveillance
EU MDR 2017/745 (fully applicable May 2021) replaces MDD/AIMDD with a risk-based classification system (Class I-III), mandatory clinical evaluation, post-market clinical follow-up, and EUDAMED registration for all… - EU Medical Devices Regulation 2017/745 (MDR) - Conformity Assessment and CE Marking
Regulation (EU) 2017/745 (MDR) replaced Directive 93/42/EEC from May 2021, establishing enhanced conformity assessment requirements for medical devices placed on the EU market. Higher-risk devices (Class IIa, IIb, Class… - FDA 21 CFR Part 11 - Electronic Records and Electronic Signatures
21 CFR Part 11 establishes criteria under which the FDA considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and equivalent to paper… - FDA 21 CFR Part 11 (Records)
FDA 21 CFR Part 11 establishes the U.S. requirements for electronic records and electronic signatures. It defines the criteria under which the FDA considers electronic records, electronic signatures, and handwritten… - FDA 21 CFR Part 820 (QSR)
FDA 21 CFR Part 820 is the Quality System Regulation (QSR) governing the manufacture and design of medical devices in the United States. It requires medical device manufacturers to establish a quality system to ensure… - FDA Breakthrough Devices Program - Expedited Pathways & Requirements (2026)
The FDA Breakthrough Devices Program provides expedited development, assessment, and review for devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases.… - FDA Clinical Decision Software
The FDA Guidance on Clinical Decision Support (CDS) Software (2022) provides the criteria under which software functions are NOT considered medical devices under Section 520(o)(1)(E) of the FD&C Act. It focus on… - FDA Clinical Decision Support (CDS) Software Guidance Update - January 2026 Final
The FDA issued the final Clinical Decision Support Software guidance in January 2026, refining the 21st Century Cures Act criteria for when CDS functions are excluded from the definition of a medical device. Key updates… - FDA De Novo Classification Process for Novel Medical Devices (2026)
The FDA De Novo classification process provides a pathway to classify novel medical devices for which there is no legally marketed predicate device, but whose risk profile is low to moderate (Class I or II). Successful… - FDA Final Rule on Laboratory Developed Tests (LDTs) - 21 CFR 809.3 Amendment and 4-Year Phaseout (May 2024)
FDA's Final Rule on Medical Devices - Laboratory Developed Tests (89 FR 37286, published 6 May 2024, effective 5 July 2024) amends 21 CFR Section 809.3 to make explicit that in vitro diagnostic products (IVDs) are… - FDA Quality Management System Regulation (QMSR) - 21 CFR Part 820 incorporating ISO 13485:2016, with 2025 Technical Amendments
21 CFR Part 820, the Quality Management System Regulation (QMSR), sets out current good manufacturing practice (CGMP) requirements and requires manufacturers to document a quality management system that complies with… - FDA Section 524B - Cybersecurity in Medical Devices (2026 Enforcement)
Section 524B of the FD&C Act requires manufacturers of cyber devices to design, develop, and maintain processes to ensure cybersecurity throughout the device lifecycle. Key obligations include cybersecurity risk… - FDA Software as a Medical Device (SaMD) Action Plan and AI/ML-Based SaMD Guidance 2022 - Predetermined Change Control Plan (PCCP) and Algorithmic Transparency Requirements
This guidance establishes principles for the regulation of Software as a Medical Device (SaMD), including risk categorization, quality management, and clinical evaluation, as developed by the International Medical… - FDA Software as a Medical Device (SaMD) Premarket Review Framework (2026 Update)
The FDA regulates Software as a Medical Device (SaMD), including AI/ML-enabled software, using a risk-based approach for premarket submissions (510(k), De Novo, or PMA). Manufacturers must provide comprehensive… - FDA Software as a Medical Device (SaMD) Risk Matrix
A risk-based framework for classifying software intended for medical purposes independently of hardware, based on IMDRF categorizations and FDA safety standards. - FDA-EMA-CIOMS AI in Pharmacovigilance Principles 2026
Joint principles and CIOMS WG XIV guidance emphasize human oversight, bias mitigation, and validation of AI for signal detection and adverse event processing. - FRAMEWORK FOR FDA’S REAL WORLD EVIDENCE PROGRAM
Pursuant to the 21st Century Cures Act, which added section 505F to the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Food and Drug Administration (FDA) has created a framework for evaluating the potential use of… - France HDS Certification - Hebergement de Donnees de Sante (Health Data Hosting, CSP Art. L1111-8)
HDS (Hebergeur de Donnees de Sante) certification is the mandatory French certification for hosting personal health data, established by Article L.1111-8 of the Code de la sante publique as modified by loi numero… - GCC Health Data Harmonization Framework & Cross-Border Sharing (2026)
The Gulf Cooperation Council (GCC) Health Data Harmonization Framework promotes interoperability, unified standards for electronic health records, and secure cross-border data sharing while respecting national… - Germany Digital Act (DigiG) & DiGA Framework - Digital Health Applications (2026)
The Digital Act (DigiG) and Digital Healthcare Act (DVG) expand reimbursement for Digital Health Applications (DiGA) under statutory health insurance. Manufacturers must demonstrate safety, performance, and quality;… - Global Clinical Trial Data Sharing & Transparency Obligations (2026)
Sponsors must comply with increasing requirements for clinical trial data transparency, including registration, summary results posting (ClinicalTrials.gov, EudraCT, etc.), individual participant data (IPD) sharing… - Global Pharmacovigilance Database Interoperability & Data Sharing (2026)
Regulatory requirements for the electronic exchange of pharmacovigilance information, specifically Individual Case Safety Reports (ICSRs), between pharmaceutical companies, national regulators, and global databases… - Good Clinical Practice (GCP)
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. Based on the ICH E6(R2) guideline,… - Good Machine Learning Practice for Medical Device Development: Guiding Principles
The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) have jointly identified 10 guiding principles that can inform the… - Good Mfg Practice (GMP)
Good Manufacturing Practice (GMP) (21 CFR Parts 210 and 211) is the primary U.S. and global standard for ensuring that pharmaceutical and medical device products are consistently produced and controlled according to… - Guidance for Industry Electronic Source Data in Clinical Investigations
This guidance provides recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated… - Guidance on Digital Health Technologies - Software as a Medical Device (SaMD) Classification, Advertising Rules and Post-Market Monitoring
This guidance outlines the Therapeutic Goods Administration's (TGA) regulatory framework for Software as a Medical Device (SaMD) in Australia, including classification rules based on risk, advertising requirements under… - Guideline on good pharmacovigilance practices (GVP) Module VI - Management and reporting of suspected adverse reactions to medicinal products (Rev 3)
This regulation requires Marketing Authorisation Holders (MAHs) in the EU to record all suspected adverse reactions and report them electronically to the EudraVigilance database. As per section VI.C., serious suspected… - Health AI Bias Detection, Mitigation & Fairness Assurance (2026)
Regulatory expectations and technical standards for detecting and mitigating algorithmic bias in medical AI. Prevents discriminatory health outcomes by mandating representative training datasets, continuous equity… - Health AI Transparency & Explainability Requirements (2026)
AI systems in healthcare must provide appropriate transparency and explainability to clinicians, patients, and regulators. This includes model cards, technical documentation, local and global interpretability methods,… - Health and Social Care Act 2008, Section 20: Regulation of regulated activities
Organizations carrying on regulated activities must comply with regulations established by the Secretary of State concerning service quality, safety, personnel fitness, premises, record-keeping, and transparency to… - Health Data Anonymisation, Pseudonymisation & De-identification Techniques (2026)
Technical and legal standards for stripping health data of identifiable markers to enable secondary research and AI training without violating patient privacy. Distinguishes between pseudonymisation (reversible, still… - Health Data Breach Notification - Global Timelines & Obligations (2026)
Regulatory requirements for managing, investigating, and reporting breaches of Protected Health Information (PHI). Dictates strict reporting timelines to authorities (e.g., 72 hours under GDPR, 60 days under HIPAA) and… - Health Data Ethics Committees & Oversight Governance (2026)
Governance framework for Institutional Review Boards (IRBs) and specialized Health Data Access Committees (DACs) overseeing the secondary use of clinical data. Ensures that research and AI model training using patient… - Health Data Quality Framework & Governance (2026)
A comprehensive framework ensuring that health data utilized for clinical care, secondary research, and AI model training meets strict quality dimensions including completeness, consistency, accuracy, and timeliness.… - Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009
The HITECH Act strengthens HIPAA privacy and security rules by requiring public notification for breaches of unsecured Protected Health Information (PHI), increasing penalties for non-compliance, and promoting the… - Health Information Technology for Economic and Clinical Health (HITECH) Act, Title XIII of the American Recovery and Reinvestment Act of 2009
The HITECH Act strengthens HIPAA's privacy and security rules by introducing mandatory breach notification requirements for unsecured Protected Health Information (PHI) and establishing increased, tiered civil monetary… - HIPAA Breach Notification Rule
A breach of unsecured protected health information, as defined under 45 CFR § 164.402, has been confirmed following a risk assessment that did not demonstrate a low probability of compromise. Given this event affects… - HIPAA Breach Notification Rule (45 CFR Parts 164.400-414) - Unsecured Protected Health Information Breach Response
This rule requires HIPAA-covered entities and their business associates to provide notification to affected individuals, the Secretary of Health and Human Services (HHS), and, in some cases, the media following a breach… - HIPAA Security Rule
The HIPAA Security Rule (45 CFR Part 160 and Part 164) establishes U.S. national standards for the protection of Electronic Protected Health Information (ePHI). It focuses on ensure the confidentiality, integrity, and… - HL7 FHIR Interoperability (Release 4)
Standardized RESTful API architecture for electronic health information exchange, using modular Resources to enable computable healthcare data across disparate systems. - HL7 FHIR R4 (4.0.1) Implementation Guide - RESTful API Specification for Health Data Exchange and Resource Types
This standard requires healthcare systems to implement a RESTful API for exchanging electronic health information using a defined set of data structures called 'Resources'. Conformance, as defined in Section 2.1,… - HL7 FHIR Release 5 (R5) - Governance, Interoperability, and Compliance Obligations
HL7 FHIR R5 is the global standard for exchanging healthcare information electronically. Organisations implementing FHIR must ensure semantic interoperability, security (OAuth2, SMART-on-FHIR), privacy (Consent… - HL7 FHIR v4 (Interoperability)
HL7 FHIR (Fast Healthcare Interoperability Resources) Release 4 is the global standard for electronic healthcare data exchange. It defines a set of 'Resources' that represent granular clinical and administrative data,… - ICH E2E Pharmacovigilance Planning & Global Pharmacovigilance Obligations (2026)
ICH E2E and related guidelines establish international standards for pharmacovigilance planning, risk management plans (RMPs), signal detection, periodic benefit-risk evaluation reports (PBRERs), and post-authorisation… - ICH E6(R3) Good Clinical Practice Guideline (2026)
ICH E6(R3) provides the international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human participants. It emphasises quality-by-design, risk-based… - ICH E8(R1) General Considerations for Clinical Studies
This guideline requires sponsors of clinical studies to proactively build quality into study design and conduct using a risk-based approach, focusing on factors critical to ensuring patient safety and the reliability of… - ICH E9(R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials
This addendum requires clinical trial sponsors to precisely define the 'estimand' (the treatment effect to be estimated) using a structured framework and conduct sensitivity analyses to assess the robustness of results.… - ICH Harmonised Guideline Good Clinical Practice (GCP) E6(R3)
This guideline establishes unified standards for clinical trials to protect human subjects and ensure data integrity, applying to sponsors, investigators, and institutions. It mandates a quality-by-design and… - ICH Harmonised Guideline Good Clinical Practice (GCP) E6(R3)
This guideline provides a unified standard for the European Union, Japan, USA, and other regions on the conduct of clinical trials, emphasizing a quality-by-design and risk-based approach to protect human subjects and… - ICH Harmonised Guideline Q9(R1) Quality Risk Management
This guideline requires pharmaceutical manufacturers to implement a systematic, science-based Quality Risk Management (QRM) process throughout the product lifecycle to ensure patient safety and product quality. As… - ICH Harmonised Tripartite Guideline Q8(R2) Pharmaceutical Development
This guideline requires pharmaceutical manufacturers to implement a systematic, science- and risk-based approach to product development, known as Quality by Design (QbD). This involves defining a Quality Target Product… - ICH Q10 Pharmaceutical Quality System
This guideline provides a model for a pharmaceutical quality system (PQS) that applies throughout the product lifecycle, complementing regional GMPs by enhancing product quality and availability. It requires companies… - ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
This guideline provides a framework for managing post-approval Chemistry, Manufacturing, and Controls (CMC) changes for pharmaceutical products, enabling a more predictable and efficient regulatory process. It… - ICH Q1A(R2) Stability Testing of New Drug Substances and Drug Products
This guideline defines the core stability data package required for a new drug substance or drug product registration application within the ICH regions, specifying storage conditions, study durations, and data… - ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
This guide provides Good Manufacturing Practice (GMP) principles for manufacturing Active Pharmaceutical Ingredients (APIs), requiring a comprehensive quality management system to ensure APIs meet purity and quality… - ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
This guideline provides recommendations on the necessary nonclinical studies to support the development of anticancer pharmaceuticals in patients with advanced disease and limited therapeutic options. It outlines a… - IEC 62304 - Medical Device Software Lifecycle Processes (2026)
The globally recognized foundational standard defining the lifecycle processes required for developing medical device software. It mandates a rigorous, risk-based approach to software architecture, detailed requirement… - IEC 62304 (Medical Software)
IEC 62304 is the international standard for medical device software lifecycle processes. It defines the framework of processes, activities, and tasks for the safe design and maintenance of medical software, regardless… - IEC 62304:2006+AMD1:2015 Medical Device Software - Software Life Cycle Processes for Safety Classification
This international standard defines the life cycle requirements for medical device software, mandating a risk-based approach where all software is assigned a safety class (A, B, or C) based on its potential to cause… - IEC 82304-1 (Health Software)
IEC 82304-1:2016 is the international standard for general health software product safety. It is designed for software products that do not have dedicated hardware and are used in health environments (e.g., lifestyle,… - Illinois BIPA Biometric & Health AI Compliance 2026
BIPA requires explicit consent for biometric data collection in health AI tools (facial recognition, voice analysis). 2026 enforcement focuses on telehealth and digital therapeutics. - IMDRF SaMD Risk Framework
The IMDRF Software as a Medical Device (SaMD) Risk Categorization Framework provides a globally harmonized method for classifying the risk of independent medical software. It categorizes SaMD into four levels (I, II,… - India Ayushman Bharat Digital Mission (ABDM) - Health Data Management and Governance Policy
ABDM creates a federated digital health ecosystem with ABHA (Ayushman Bharat Health Account), consent managers, and standardised data exchange. The Health Data Management Policy enforces patient consent, data… - India CDSCO - Medical Devices Rules 2017 (2026 Amendments) & Risk-Based Regulation
The Central Drugs Standard Control Organisation (CDSCO) regulates medical devices under the Medical Devices Rules 2017 (amended 2026). Devices are classified into Classes A-D with increasing regulatory controls,… - Information Blocking (45 CFR Part 171) under the 21st Century Cures Act
This rule, under 45 CFR § 171.103, prohibits practices by healthcare providers, health IT developers, and health information networks/exchanges that are likely to interfere with, prevent, or materially discourage the… - Informed Consent in Digital Health & AI-Driven Care (2026 Standards)
Informed consent in digital health environments must be specific, granular, freely given, and easily revocable. It requires clear disclosure of AI involvement, data uses (including secondary and international… - International Medical Device Regulatory Harmonization - IMDRF & Global Alignment (2026)
Strategic framework detailing the guidelines and standards set forth by the International Medical Device Regulators Forum (IMDRF) to accelerate international medical device harmonization. Key initiatives include the… - ISMP Medication Safety
The ISMP (Institute for Safe Medication Practices) Best Practices provide a set of consensus-based national standards for reducing medication errors in hospitals and healthcare settings. They focus on high-alert… - ISO 13485 (Medical QMS)
ISO 13485:2016 is the global standard for Medical Device Quality Management Systems (QMS). It specifies requirements for a QMS where an organization needs to demonstrate its ability to provide medical devices and… - ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 13485:2016 specifies requirements for a quality management system (QMS) for organizations involved in the lifecycle of a medical device. It requires organizations to demonstrate their ability to provide medical… - ISO 14971 (Medical Risk)
ISO 14971:2019 is the international standard for the application of risk management to medical devices. It provides a framework for manufacturers to identify hazards, estimate and evaluate risks, control these risks,… - ISO 15189 (Medical Labs)
ISO 15189:2022 is the international standard for medical laboratories, specifying requirements for quality and competence. It addresses both the technical competence of the laboratory and its ability to deliver… - ISO 15378:2017 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to Good Manufacturing Practice (GMP)
This standard specifies Good Manufacturing Practice (GMP) requirements for the quality management system (QMS) of manufacturers of primary packaging materials for medicinal products. It integrates ISO 9001:2015 with GMP… - ISO 27799 (Health InfoSec)
ISO 27799:2016 (Health informatics - Information security management in health using ISO/IEC 27002) is the primary standard for implementing ISO 27001 in healthcare. It provides specific guidance on the additional… - ISO 27799:2025 - Health Informatics - Information Security Management in Health
ISO 27799 provides healthcare-specific guidance on implementing ISO/IEC 27002 controls within an Information Security Management System (ISMS). It addresses unique risks in health informatics including patient safety,… - Japan PMDA - Software as a Medical Device (SaMD) and AI Medical Device Guidelines (2026)
The Pharmaceuticals and Medical Devices Agency (PMDA) regulates Software as a Medical Device (SaMD) and AI/ML-based medical devices under the Pharmaceutical and Medical Device Act. Requirements include risk… - Kenya Digital Health Act 2024 & Data Protection (Health Data) Regulations (2026)
The Kenya Digital Health Act 2024 establishes the legal framework for digital health services, electronic health records, telemedicine, and the Kenya Health Information Exchange (KHIE). It mandates interoperability… - Laboratory Developed Tests (LDTs) - FDA Oversight & Global Alignment (2026)
The FDA’s final rule on Laboratory Developed Tests brings most LDTs under medical device regulation with phased enforcement. Requirements include registration, listing, adverse event reporting, quality systems (QMSR),… - Malaysia Medical Device Authority (MDA) SaMD & Digital Health Framework 2026
MDA aligns SaMD classification with IMDRF while requiring local registration and cybersecurity testing. 2026 guidance introduces fast-track for AI-enabled devices with reference approvals from FDA, CE, or HSA. - Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions
This FDA guidance enables manufacturers of AI/ML-based medical devices to pre-authorize a set of planned modifications within a Predetermined Change Control Plan (PCCP) as part of a premarket submission (510(k), De… - MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 - MDR and Regulation (EU) 2017/746 - IVDR
This guidance provides criteria for qualifying software as a Medical Device (MDSW) or In Vitro Diagnostic (IVD) Medical Device and outlines the risk-based classification rules under EU MDR and IVDR. Manufacturers must… - Medical Device ESG & Sustainability Requirements (2026)
Medical device manufacturers face growing ESG obligations including carbon footprint reporting, sustainable design, conflict minerals due diligence, plastic reduction, circular economy principles (remanufacturing,… - Medical Device Post-Market Surveillance (PMS) & Vigilance Systems - Global Requirements (2026)
Manufacturers must maintain proactive, systematic post-market surveillance systems to monitor device performance, detect trends, and take corrective actions. This includes Periodic Safety Update Reports (PSUR),… - Medical Device Remanufacturing, Refurbishment & Reprocessing - Regulatory Requirements (2026)
Remanufacturing and refurbishment of single-use and reusable medical devices are strictly regulated. Entities must meet original manufacturer standards for safety and performance, including full reprocessing validation,… - Medical Device Software Validation & Lifecycle Processes - IEC 62304 (2026)
IEC 62304 specifies lifecycle requirements for the development of medical software and software within medical devices. It mandates a risk-based software safety classification (Class A, B, C) which determines the… - Medical Device Supply Chain Due Diligence & Resilience Requirements (2026)
Manufacturers must conduct robust supply chain due diligence covering cybersecurity, forced labour, conflict minerals, environmental compliance, and single points of failure. NIS2, DORA, EU MDR, FDA, and other… - Medical Device Usability Engineering & Human Factors Validation (2026)
Regulatory framework governing the application of usability engineering (human factors) to medical devices to minimize use errors and use-associated risks. Mandated by FDA and EU MDR, it requires manufacturers to…
+ 148 more nodes in this pillar — see the full registry at /intelligence or the discovery index at /api/v1/nodes/index.json.