MHRA (opens in a new tab)
Regulates medicines, medical devices, and blood components. Ensures safety, quality, and efficacy. Issues marketing authorisations.
Enforces 15 Acts this sector relies on.
Sector
Healthcare & Social Care
Hospitals, GP practices, care homes, health services and social care providers.
- Guides
- 53
- Regulators
- 18
- Legislation
- 46
- Journeys
- 14
Start here
See all 14Step-by-step routes through what healthcare & social care businesses must do.
Ranked by how thoroughly each journey maps this sector's guidance.
Journey
Run a healthcare business
Ongoing compliance for CQC-registered healthcare providers covering inspections, professional registration, safeguarding, clinical governance, medicines management, and staff obligations
JourneyMeet environmental compliance requirements
Navigate your environmental obligations including waste duty of care, pollution prevention, packaging responsibilities, and energy reporting
JourneyStart a healthcare business
Launch a healthcare or social care business with CQC registration
Who regulates you
See all 18The bodies that set rules and enforce compliance for healthcare & social care.
Ranked by how much of the legislation this sector's guides cite each one enforces.
CIW (opens in a new tab)
Registers and inspects social care and childcare services in Wales. Regulates care homes, domiciliary care, children's homes, and childminders.
Enforces 10 Acts this sector relies on.
CQC (opens in a new tab)
Independent regulator of health and social care in England. Registers, monitors, inspects and rates hospitals, care homes, GP practices, dental surgeries, and other care …
Enforces 9 Acts this sector relies on.
Care Inspectorate (opens in a new tab)
Registers and inspects care services in Scotland including care homes, childcare, and support services. Publishes inspection grades and can take enforcement action.
Enforces 5 Acts this sector relies on.
HSE (opens in a new tab)
Workplace health, safety, and welfare regulation across all industries. Enforces the Health and Safety at Work Act 1974 and related regulations. Investigates serious incidents …
Enforces 5 Acts this sector relies on.
ICO (opens in a new tab)
Data protection, freedom of information, privacy and electronic communications regulation. Enforces UK GDPR and Data Protection Act 2018. Issues fines for breaches. All businesses …
Enforces 4 Acts this sector relies on.
Key legislation
See all 46The Acts and statutory instruments that set duties for this sector.
Ranked by how many of this sector's guides cite each — the legislation most central to the sector appears first.
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Act
Health and Social Care Act 2008 (opens in a new tab) Cited by 13 of this sector's guides
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Act
RISCWA 2016 (opens in a new tab) Cited by 11 of this sector's guides
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SI
Medical Devices Regulations 2002 (opens in a new tab) Cited by 11 of this sector's guides
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Act
Public Services Reform (Scotland) Act 2010 (opens in a new tab) Cited by 9 of this sector's guides
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Act
Health and Personal Social Services (Quality, Improvement a… (opens in a new tab) Cited by 9 of this sector's guides
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SI
Health and Social Care Act 2008 (Regulated Activities) Regu… (opens in a new tab) Cited by 8 of this sector's guides
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SI
Regulated Services (Service Providers and Responsible Indiv… (opens in a new tab) Cited by 4 of this sector's guides
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SI
Human Medicines Regulations 2012 (opens in a new tab) Cited by 4 of this sector's guides
All guidance for healthcare & social care
53 guides for this sector.
Grouped by topic area, with the topic holding the most guidance first; within each, the most comprehensive guides lead.
Sector-Specific
53 guides
- Social care registration and regulators Guide to registering as a social care provider across all four UK nations. Covers CQC registration in England, Care Inspectorate …
- Start a clinical laboratory service How to set up and operate a clinical laboratory in the UK. Covers UKAS accreditation, CQC registration, HTA licensing, MHRA …
- Running clinical trials in the UK How to get MHRA authorisation for clinical trials of investigational medicinal products (CTIMPs). Covers combined review process, GCP requirements, safety …
- Healthcare professional registration requirements Registration requirements with GMC, NMC, GDC, GPhC, and HCPC for healthcare employers and professionals.
- Run a care home or other residential care service Residential care is one of the most closely regulated activities in the UK. Adult care and nursing homes and domiciliary …
- Register with the Care Quality Commission (CQC) Complete step-by-step guide to CQC registration for healthcare providers in England, including what activities require registration, annual fees, fit and …
- Data protection for healthcare providers How healthcare providers must handle patient data under UK GDPR, including special category health data requirements, Caldicott Principles, the common …
- Operating care services across UK nations: cross-border registration and compliance Comprehensive guide for care providers operating in more than one UK nation. Covers separate registration requirements with each devolved inspectorate, …
- Healthcare and social care regulation (CQC) CQC registration requirements for health and social care providers in England, including detailed guidance on regulated activities, costs, and devolved …
- Healthcare premises and equipment requirements CQC Regulation 15 premises and equipment requirements, radiation protection under IRR 2017, healthcare ventilation, medical gas systems, decontamination of reusable …
- Infection prevention and control for healthcare providers How to meet infection prevention and control (IPC) requirements under the Health and Social Care Act 2008 Code of Practice …
- MHRA authorisation for medicines and medical devices How to obtain MHRA authorisation for medicines and medical devices in the UK. Covers Marketing Authorisations, wholesale dealer licences, manufacturer …
- MHRA licensing for medicines and medical devices MHRA licensing requirements for manufacturing, distributing, and importing medicines and medical devices in the UK.
- Healthcare regulation across the UK nations Comparison reference for healthcare regulation in England (CQC), Scotland (HIS and Care Inspectorate), Wales (HIW and CIW), and Northern Ireland …
- Healthcare provider annual compliance checklist Annual checklist of recurring compliance obligations for CQC-registered healthcare providers covering registration, workforce, clinical governance, premises, data protection, and policy …
- Set up and run a regulated health practice Opening a GP surgery, dental practice, clinic, pharmacy or optical practice means clearing two gateways — registering the service with …
- Clinical governance and quality improvement Clinical governance framework for healthcare providers covering patient safety culture, clinical audit, incident investigation, duty of candour, complaints handling, and …
- NHS Data Security and Protection Toolkit compliance How to complete the NHS Data Security and Protection Toolkit (DSPT) annual self-assessment if you handle NHS patient data. Covers …
- Medicines and controlled drugs compliance Legal requirements for handling, storing and administering medicines including controlled drugs in healthcare settings.
- UKCA and CE marking for medical devices How to choose between UKCA and CE marking for your medical device on the GB market. Covers UKCA marking via …
- Understanding care regulation in Wales: CIW and RISCA 2016 How Care Inspectorate Wales (CIW) regulates care services under RISCA 2016, the Responsible Individual model, Welsh Language Standards obligations, and …
- Understanding the Care Inspectorate Scotland Comprehensive explainer of how the Care Inspectorate Scotland operates, its regulatory model under the Public Services Reform (Scotland) Act 2010, …
- CIW inspection preparation checklist Verification checklist for CIW inspection readiness. Covers Statement of Purpose, Responsible Individual duties, staff qualifications and Social Care Wales registration, …
- Devolved care inspectorates: quick comparison reference Quick-lookup reference comparing the three devolved care inspectorates: Care Inspectorate (Scotland), CIW (Wales), and RQIA (Northern Ireland). Covers registration, fees, …
- Register a health or social care service with RQIA Step-by-step guide to registering a health or social care service with the Regulation and Quality Improvement Authority (RQIA) in Northern …
- Register with the Care Inspectorate Scotland Step-by-step guide to registering a care service with the Care Inspectorate Scotland under the Public Services Reform (Scotland) Act 2010, …
- Understanding RQIA: healthcare and social care regulation in Northern Ireland How healthcare and social care regulation works in Northern Ireland under the Regulation and Quality Improvement Authority (RQIA). Explains the …
- Medical devices and equipment compliance Regulatory requirements for medical devices including vigilance reporting and equipment maintenance.
- Safeguarding and mental capacity in healthcare Legal duties for safeguarding vulnerable adults and making decisions for people who lack mental capacity.
- Which education and childcare rules apply to your business Education and childcare businesses are regulated by what they do and who they serve. Early years and out-of-school childcare register …
- Medical devices: placing on the GB market How to comply with the UK Medical Devices Regulations 2002 when placing medical devices on the Great Britain market. Covers …
- Register a care service with Care Inspectorate Wales (CIW) Step-by-step guide to registering a regulated care service with Care Inspectorate Wales (CIW) under the Regulation and Inspection of Social …
- Meet RISCA 2016 compliance requirements for care services in Wales How to meet the ongoing compliance requirements under the Regulation and Inspection of Social Care (Wales) Act 2016 and the …
- Social care workforce qualifications and staffing Workforce requirements for social care providers across the UK. Covers the Care Certificate and qualifications in England, mandatory SSSC registration …
- Respond to CIW enforcement action in Wales What to do when Care Inspectorate Wales imposes conditions, issues improvement notices or restriction notices, or initiates cancellation of registration. …
- SSSC workforce registration for care providers in Scotland How to ensure your care staff register with the Scottish Social Services Council (SSSC), including registration categories, qualification requirements, timescales, …
- Prepare for an RQIA inspection Inspection readiness checklist for RQIA-registered services in Northern Ireland. Covers documentation, staffing records, care plans, premises environment, complaints handling, safeguarding, …
- Post-market surveillance for medical devices How to establish and maintain a post-market surveillance system for medical devices on the GB market under the enhanced requirements …
- Register your care staff with Social Care Wales How to ensure your care staff register with Social Care Wales, including mandatory registration categories, qualification requirements, the Code of …
- Report a medical device safety incident to MHRA Step-by-step guide to reporting serious medical device incidents to MHRA via the MORE portal. Covers incident identification, timeline classification (2, …
- Which health and care rules apply to your business Health and care businesses are regulated twice over: the service registers with a care regulator (CQC in England, with separate …
- Care Inspectorate Scotland inspection preparation checklist Checklist for Care Inspectorate inspection readiness covering documentation, staff training records, care plans, Health and Social Care Standards evidence, premises, …
- Placing medical devices on the Northern Ireland market How to comply with the Northern Ireland medical device regime under the Windsor Framework. Covers EU MDR/IVDR requirements, CE marking, …
- Social care business planning and insurance Business planning essentials for social care providers. Covers insurance requirements, Care Act 2014 obligations in England, financial viability and fee …
- Software and AI as medical devices (SaMD/AIaMD) How MHRA regulates software and AI-powered medical devices. Covers the SaMD definition and boundary guidance, current classification under UK MDR …
- Respond to RQIA enforcement action What to do if RQIA takes enforcement action against your health or social care service in Northern Ireland. Covers failure …
- Classify your medical device for the GB market How to classify your medical device under the UK Medical Devices Regulations 2002. Covers Class I through III for general …
- AI medical device compliance MHRA requirements for AI as a Medical Device (AIaMD) and Software as a Medical Device (SaMD). Covers classification, registration, technical …
- Medical device compliance checklist Verification checklist for medical device manufacturers and UK Responsible Persons. Covers device classification, conformity assessment, technical documentation, UKCA/CE marking, MHRA …
- Meet RQIA Minimum Care Standards How to meet the Minimum Care Standards that RQIA uses to assess your health or social care service in Northern …
- Meet Scotland's Health and Social Care Standards How to meet Scotland's Health and Social Care Standards (My support, my life), covering the five headline standards, self-assessment approaches, …
- Responding to Care Inspectorate enforcement action in Scotland What to do when the Care Inspectorate imposes conditions, issues improvement notices, or initiates cancellation of your registration, including your …
- Choosing a UK Approved Body for medical devices How to select and engage a UK Approved Body for conformity assessment of your medical device. Covers the 7 designated …
All journeys
- Run a healthcare business Ongoing compliance for CQC-registered healthcare providers covering inspections, professional registration, safeguarding, clinical governance, medicines management, and staff obligations
- Meet environmental compliance requirements Navigate your environmental obligations including waste duty of care, pollution prevention, packaging responsibilities, and energy reporting
- Start a healthcare business Launch a healthcare or social care business with CQC registration
- Healthcare compliance quick check Quick compliance check for experienced healthcare providers. Covers CQC registration, professional registrations, DBS checks, medicines audit, controlled drugs …
- Start a social care provider business End-to-end learning path for starting a social care business. Covers which regulator applies, CQC registration, registered manager requirements, …
- Start a childcare business Launch a childcare business with Ofsted registration, safeguarding, and EYFS compliance
- Wales care compliance quick check Quick checklist for Wales care providers to verify CIW registration, Responsible Individual appointment, Social Care Wales workforce registration, …
- RQIA registration quick check Quick checklist for Northern Ireland care providers to check whether their service needs RQIA registration, fit person requirements, …
- Respond to a CQC investigation or enforcement action What to do if your healthcare or social care service faces CQC enforcement action. Covers understanding the type …
- Scotland care compliance quick check Quick compliance check for Scotland care providers covering Care Inspectorate registration, SSSC workforce registration, Health and Social Care …
- Expanding your childcare business Grow your childcare business through multi-site expansion, franchising, acquisitions, or building strong Ofsted inspection outcomes
- Respond to a medicines or controlled drugs incident What to do when a medicines incident occurs: medication error, controlled drug discrepancy, or CD theft/loss. Covers securing …
- Starting a social care provider business Step-by-step guide to starting a social care business — from choosing your regulator through workforce requirements to financial …
- Running a childcare setting Ongoing compliance for childcare providers covering inspections, safeguarding, SEND, food safety, and staff management
Subsectors
SIC 2007 divisions covered by this sector.