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Table of Contents
National Health Act, 2003
Notice No. 869 of 2004
Act
Preamble
1. Definitions
Chapter 1 : Objects of Act, responsibility for health and eligibility for free health services
2. Objects of Act
3. Responsibility for health
4. Eligibility for free health services in public health establishments
Chapter 2 : Rights and Duties of Users and Health Care Personnel
5. Emergency treatment
6. User to have full knowledge
7. Consent of user
8. Participation in decisions
9. Health service without consent
10. Discharge reports
11. Health services for experimental or research purposes
12. Duty to disseminate information
13. Obligation to keep record
14. Confidentiality
15. Access to health records
16. Access to health records by health care provider
17 Protection of health records
18. Laying of complaints
19. Duties of users
20. Rights of health care personnel
Chapter 3 : National Health
21. General functions of national department
22. Establishment and composition of National Health Council
23. Functions of National Health Council
24. National Consultative Health Forum
Chapter 4 : Provincial Health
25. Provincial health services, and general functions of provincial departments
26. Establishment and composition of Provincial Health Council
27. Functions of Provincial Health Council
28. Provincial consultative bodies
Chapter 5 : District Health System
29. Establishment of district health system
30. Division of health districts into subdistricts
31. Establishment of district health councils
32. Health services to be provided by municipalities
33. Preparation of district health plans
34. Transitional arrangements concerning municipal health services
Chapter 6 : Health Establishments
35. Classification of health establishments
36. Certificate of need
37. Duration of certificate of need
38. Appeal to Minister against Director-General's decision
39. Regulations relating to certificates of need
40. Offences and penalties in respect of certificate of need
41. Provision of health services at public health establishments
42. Clinics and community health centre committees
43. Health services at non-health establishments and at public health establishments other
44. Referral from one public health establishment to another
45. Relationship between public and private health establishments
46. Obligations of private health establishments
47. Evaluating services of health establishments
Chapter 7 : Human Resources Planning and Academic Health Complexes
48. Development and provision of human resources in national health system
49. Maximising services of health care providers
50. Forum of Statutory Health Professional Councils
51. Establishment of academic health complexes
52. Regulations relating to human resources
Chapter 8 : Control of use of blood, blood products, tissue and gametes in humans
53. Establishment of national blood transfusion service
54. Designation of authorised institution
55. Removal of tissue, blood, blood products or gametes from living persons
56. Use of tissue, blood, blood products or gametes removed or withdrawn from living person
57. Prohibition of reproductive cloning of human beings
58. Removal and transplantation of human tissue in hospital or authorised institution
59. Removal, use or transplantation of tissue, and administering of blood and blood product
60. Payment in connection with the importation, acquisition or supply of tissue, blood, blo
61. Allocation and use of human organs
62. Donation of human bodies and tissue of deceased persons
63. Human bodies, tissue, blood, blood products or gametes may be donated to prescribed institution or person
64. Purposes of donation of body, tissue, blood or blood products of deceased persons
65. Revocation of donation
66. Post mortem examination of bodies
67. Removal of tissue at post-mortem examinations and obtaining of tissue by institutions a
68. Regulations relating to tissue, cells, organs, blood, blood products and gametes
Chapter 9 : National Health Research and Information
69. National Health Research Committee
70. Identification of health research priorities
71. Research on or experimentation with human subjects
72. National Health Research Ethics Council
73. Health research ethics committees
74. Co-ordination of national health information system
75. Provincial duties in relation to health information
76. Duties of district health councils and municipalities
Chapter 10 : Office of Health Standards Compliance, Board, Inspections and Environmental Health Investigations, Health Officers and Inspectors, Complaints and Appeal Procedures
77. Establishment of Office of Health Standards Compliance
78. Objects of Office
79. Functions of Office
79A. Establishment of Board
79B. Composition of the Board
79C. Appointment of members of Board
79D. Chairperson and vice-chairperson of Board
79E. Disqualification from membership of Board and vacation of office
79F. Meetings of Board
79G. Committees of Board
79H. Appointment of Chief Executive Officer
79I. Functions of Chief Executive Officer
79J. Delegation of powers and assignment of duties by Chief Executive Officer
79K. Accountability of and reporting by Chief Executive Officer
80. Appointment of health officers
81. Appointment of Ombud
81A. Functions of Ombud
81B. Independence, impartiality and accountability of Ombud
82. Inspections
82A. Non-compliance with prescribed norms and standards
83. Environmental health investigations
84. Entry and search of premises with warrant
85. Identification prior to entry, and resistance against entry
86. Entry and search of premises without warrant
86A. Constitutional right to privacy
87. Disposal of items seized by health officer
88. Miscellaneous provisions relating to health officers, inspectors and compliance procedures
88A. Appeals against decisions of Office or Ombud
89. Offences and penalties
Chapter 11 : Regulations
90. Regulations
Chapter 12 : General Provisions
91. Minister may appoint committees
92. Assignment of duties and delegation of powers
93. Repeal of laws, and savings
94. Short title and commencement
Schedule
Laws Repealed
Regulations
Obtainance of information and processes of determination and publication of reference price lists
Notice No. R. 1214 of 2006
1. Definitions
2. Invitation for submissions
3. Infomation that may be submitted
4. Commissioning of costing surveys
5. Guidelines for submission of information
6. Principles underlying the submission of certain information
7. Verification of information
8. Determination of the Reference Price Lists
9. Publication of the Reference Price List
10. Reference Price List Review Cycle
11. Failure to make submissions
Human Stem Cells
Notice No. R. 376 of 2007
Chapter 1
1. Definitions
2. Use of stem cells
3. Application for authorisation
4. Suspension or withdrawal of authorisation
5. Keeping of records and reporting obligations
6. Database of stem cells
7. Stem cells for later therapeutic use
8. Additional powers and duties of an inspector of anatomy or investi
9. Inspection and control measures
10. Traceability
11. Data protection and confidentiality
12. Quality and safety of stem cells
13. Responsible person
14. Personnel
15. Stem cell reception
16. Stem cell processing
17. Stem cell storage conditions
18. Labelling, documentation and packaging
19. Distribution
20. Relationship between stem cell establishments and third parties
21. Offences and penalties
22. Commencement
Forensic Pathology Service, 2007
Notice No. R. 636 of 2007
Definition
Application
Forensic Pathology Service
Removal and transportation of body
Admission of body
Storage of body
Medicolegal Post Mortem Examination
Practitioners authorised to conduct post mortem examination
Additional evidence at post mortem examination
Practitioners authorised to observe post mortem examination
Protection of Records
Identification of body
Release of body
Unidentified body
Death of detained person
Medico Legal Investigation of Specific Categories of Unnatural Deaths
National Forensic Pathology Service Committee
Accounting and Reporting Requirements
Offences
Delegation
Obtainance of information and the processes of determination and publication of reference price lists
Notice No. R. 681 of 2007
1. Definitions
2. Invitation for submissions
3. Information that may be submitted
4. Guidelines for submission of information
5. Verification of information
6. Commissioning of costing surveys
7. Determination of the Reference Price Lists
8. Publication of the Reference Price List
9. Failure to make submissions
10. 2008 Reference Price List
National Health Reference Price List
[Repealed] Withdrawal of Blood from a Living Person for Testing
[Repealed] Notice No. R. 401 of 2010
Cancer Registration
Notice No. R. 380 of 2011
1. Definitions
2. Establishment of the National Cancer Registry
3. Objectives of the National Cancer Registry
4. Reporting by health establishments
5. Reporting by laboratories
6. Norms and standards
7. Confidentiality
8. Protection of data or information
9. Duty to release the data or information
10. Transmission of information from source to data system and registries or visa versa
11. Offences and penalties
12. Transitional Arrangements & Savings
Registration Form
Categories of Hospitals
Notice No. R. 655 of 2011
1. Definitions
2. Categories of public hospitals
3. District hospitals
4. Regional hospitals
5. Tertiary hospitals
6. Central Hospitals
7. Specialized hospitals
8. List of public hospitals
9. Categories of private hospitals
10. Management of public hospitals
11. National Policy
12. Transitional measures
Taking of buccal sample or withdrawal of blood from a living person for testing
Notice No. R. 944 of 2011
Definitions
Taking of buccal sample or withdrawal of blood
Training
Repeal and commencement
Research with Human Participants
Notice No. R. 719 of 2014
1. Definitions
2. Principles guiding research with human participants
3. Obligations of researchers who conduct research with human particpants
4. Research with human participants who are vulnerable
5. Informed consent for research with human participants
6. Review of proposals for research with human participants
7. Ministerial consent for non-therapeutic research with minors
8. Commencement of Regulations
Annexures
Form A : Application for Ministerial Consent for Non-Therapeutic Research with Minors
Functioning of the Office of Health Standards Compliance and Handling of Complaints by the Ombud
Notice No. 1365 of 2016
Chapter 1 : Definitions, Purpose and Application
1. Definitions and interpretation
2. Purpose of regulation
3. Scope and application
Chapter 2 : Collection of Information and Designation of Person in Charge
4. Collection of or request for information
5. Indicators of risk
6. Designation of person in charge
7. Duties of person in charge
Chapter 3 : Inspectors and Inspections
8. Appointment of inspectors
9. Skills and experience for inspectors
10. Code of conduct for inspectors
11. Formal credentials for person rendering assistance
12. Inspection strategy, procedures and plan
13. Notice of inspection to health establishments
14. Inspection process
15. Additional inspection
Chapter 4 : Inspection of Health Establishment
16. Information on approach to carrying out inspections
17. Entry, inspection and search warrant
Chapter 5 : Certification
18. Certification of health establishments
19. Renewal and extension of certification
20. Suspension of certificate
Chapter 6 : Compliance Notice, Enforcement and Appeal
21. Compliance notice to health establishment
22. Compliance enforcement
23. Written warning
24. Request for response
25. Monitoring of recommendations to relevant authority
26. Formal hearing
27. Revocation of certification and recommendation to Minister
28. Fine
29. Referral to National Prosecuting Authority
30. Appeal against decisions of Office or Ombud
31. Publication of reports and tribunal decisions
Chapter 7 : Complaints Handling and Investigation
32. Who may lay complaint
33. How to lay complaint
34. Acknowledgement of complaint and request for additonal information
35. Screening of complaints
36. Submissions regarding complaints
37. Period for completing screening
38. Decision following screening
39. Cooperation with other entities
40. Referral from other entities and the public
41. Decision to take no further action on complaint
42. Complaint investigations
43. Notice to health establishment being investigated
44. Progress reports
45. Period for completing investigation
46. Investigations register
47. Report to Minister
48. Notice of decision after investigating complaint and investigation report
49. Referral to and reports from other statutory authority or other appropriate and suitable body or entity
50. Confidentiality of information
Chapter 8 : General Provisions
51. Prescribed forms
52. Short title and commencement
Annexure
Prescribed Forms
OHSC 1 : Health establishment information
OHSC 2 : Certificate of appointment as an inspector
OHSC 3 : Notice of inspection
OHSC 4 : Certificate of compliance
OHSC 5 : Application for renewal and extension of certification
OHSC 6 : Compliance Notice
OHSC 7 : Written Warning
OHSC 8 : Notice of Formal Hearing
OHSC 9 : Notice of Appeal
Emergency Care at Mass Gathering Events Regulations, 2017
Notice No. 566 of 2017
1. Definitions
2. Scope of application
3. Responsibilities of event organiser
4. Responsibilities of event medical service provider
5. Medical facility criteria
6. Provision of emergency medical services at event
7. Responsibilities of provincial EMS manager
8. Application for approval
9. Processing of application
10. Composition and responsibilities of Inspectorate
11. Recommendation by Inspectorate
12. Decision of provincial EMS manager
13. Appeal
14. Offences and penalties
15. Amendment of specific requirements
16. Short title
Annexures
Annexure A : Application for Approval of an Event
Annexure B
Table 1 : Allocation of score based on nature of event
Table 2 : Event Intelligence
Table 3 : Additional Considerations
Table 4 : Final Score
Annexure C
Table 5 : Minimum Resource Requirement
Emergency Medical Services Regulations, 2017
Notice No. 1320 of 2017
Part 1 : Regulatory Framework
1. Definitions
2. Scope of Application
Part 2 : EMS Advisory Committee
3. Emergency Medical Services Advisory Committee
4. Exclusion of Members of Committee
5. Declaration by Committee members
6. Termination of membership
Part 3 : Licensing of Emergency Medical Services
7. Licensing
8. Application for licence
9. Processing of application
10. Consideration of application for licence
11. Recommendations of Committee
12. Decision of Head of Department
13. Issuing of licence and licence tokens
14. Annual renewal of licence and licence token
15. Suspension or cancellation of licence
16. Reinstatement of licence and lifting of suspension
17. Amendment of licence
18. Change of ownership
19. Fees
20. Exemptions
21. Appeal
Part 4 : Inspection of Emergency Medical Services
22. Inspection for new applications
23. Inspection of registered Emergency Medical Services
Part 5 : EMS Operational Affairs
24. Display of licence and licence token
25. Name of Emergency Medical Service
26. Management of Emergency Medical Service
27. Information concerning Emergency Medical Service
28. Powers of Emergency Care Personnel
Part 6 : Miscellaneous Provisions
29. Delegations
30. Offences and penalties
31. Transitional provisions
32. Repeal
33. Short title
Annexures
Annexure A : Requirements for Emergency Medical Services
Annexure B
Airway Equipment
Endotracheal Intubation Equipment
Breathing/Ventilation Equipment
Oxygen Supply
Ventilator
Diagnostic/Therapeutic Equipment
Miscellaneous Disposable Equipment
Intravenous Therapy Equipment
Medicines Therapy Sundries
Transport and Immobilization Equipment
Other
Requirements for MICU transfers
Requirements for MICU neonatal transfers
Rescue equipment requirements
Annexure C : Emergency Medical Service Licence Application
Annexure D : Emergency Medical Services Fees
Surveillance and the Control of Notifiable Medical Conditions, 2017
Notice No. 1434 of 2017
1. Definitions
Chapter 1 : Implementation Principles and Responsibilities in relation to Notifiable Medical Conditions
2. Implementation principles
3. Responsibilities at national level
4. Responsibilities at provincial level
5. Responsibilities at health district level
6. Responsibilities at health sub-district level
7. Responsibilities at health establishment level
8. Responsibilities of health care providers
9. Responsibilities of laboratories
10. Responsibilities of pathologists and laboratory personnel
11. Responsibilities of Medical Schemes
Chapter 2 : Declaration of notifiable Medical Conditions
12. Declaration of notifiable medical conditions
13. Notification and reporting process
Chapter 3 : Prevention and Control of Notifiable Medical Conditions
14. Voluntary medical examination, prophylaxis, treatment, isolation and quarantine
15. Mandatory medical examination, prohylaxis, treatment, isolation and quarantine
16. Control of spread of notifiable medical conditions
Chapter 4 : General Matters
17. Representation
18. Confidentiality
19. Protection of health records
20. Offences and penalties
21. Repeal
22. Short title
Annexures
Annexure A
Table 1 : List of category 1 notifiable medical conditions
Table 2 : List of category 2 notifiable medical conditions
Table 3 : List of category 3 notifiable medical conditions
Table 4 : List of category 4 notifiable medical conditions
Annexure B
Table 1 : Data elements to be reported by health care providers
Table 2 : Data elements to be reported by private and public health laboratories
Table 3 : Data elements to be reported by medical schemes
Norms and Standards Regulations Applicable to Different Categories of Health Establishments, 2017
Notice No. 67 of 2018
Definitions, Purpose and Application
1. Definitions
2. Scope and application
3. Purpose of Regulations
User Rights
4. User information
5. Access to care
Clinical Governance and Clinical Care
6. User health records and management
7. Clinical management
8. Infection prevention and control programmes
9. Waste Management
Clinical Support Services
10. Medicines and Medical supplies
11. Diagnostic services
12. Blood services
13. Medical equipment
Facilities and Infrastructure
14. Management of buildings and grounds
15. Engineering services
16. Transport management
17. Security services
Governance and Human Resources
18. Governance
19. Human resources management
20. Occupational health and safety
General Provisions
21. Adverse events
22. Waiting times
23. Short title and commencement
Regulations Regarding the Rendering of Forensic Pathology Service, 2018
Notice No. R. 359 of 2018
1. Definitions
2. Application
3. Forensic Pathology Service
4. Referral of unnatural cases
5. Attending to death scene
6. Unnatural deaths in health establishments
7. Removal and transportation of body
8. Admission of body
9. Storage of body
10. Medico-legal post mortem examination
11. Practitioners authorised to conduct or assist with post mortem examination
12. Additional evidence at post mortem examination
13. Practitioners authorised to observe post mortem examinations other than those contemplated in these Regulations
14. Protection of records
15. Identification of body
16. Release of body
17. Unidentified body
18. Medico legal investigation of specific categories of unnatural deaths
19. National forensic pathology service committee
20. Accounting and reporting requirements
21. Offences
22. Delegation
23. Short title
Notices
Advisory Committee on Reference Price Lists: Appointments
Notice No. 398 of 2008
Establishment of Ministerial Advisory Committee on e-Health
Notice No. 595 of 2015
1. Definitions
2. Establishment of Ministerial Advisory Committee on e-Health
3. Composition of Committee
4. Appointment of members of Committee
5. Chairperson and vice-chairperson of Committee
6. Disqualification from membership of Committee and vacation of office
7. Working procedure
8. Appointment of ad hoc sub-committee
9. Functions of Committee
10. Conflict of interest
11. Declaration by Committee member
12. Remuneration and allowances of Committee members
13. Termination of membership
National Health Insurance Policy toward Universal Health Coverage
Notice No. 627 of 2017
Glossary of Terms
Executive Summary
Chapter 1 : Introduction and Background
1.1 Introduction
1.2 Background and Historical Context of Health Care Financing Reforms
1.3 International Context
Chapter 2 : Definition, Features and Principles of NHI
2.1 Definition
2.2 Feature of NHI
2.3 Principles
Chapter 3 : Problem Statement
3.1 Social Determinants of Health (SDH)
3.2 Burden of Disease
3.3 Structural problems in the health system
3.3.1 Leadership and Governance
3.3.2 Service delivery challenges
3.3.3 Health workforce challenges
3.3.4 Availability of Medical Products and Technologies
3.3.5 Health care financing challenges
3.3.5.1 Costly private health sector
3.3.5.2 Inequitable Health Care Financing
3.3.5.3 Fragmentation in funding pools
3.3.5.4 Out-of Pocket Payments
3.3.5.5 Weak Purchasing and Financing systems that punish the poor
3.4 Conclusion
Chapter 4 : Rationale and Benefits of NHI
Chapter 5 : National Health Insurance Coverage
5.1 The Three Dimensions of Universal Health Health Coverage (UHC)
5.2 Population coverage
5.3 Service coverage
5.3.1 Expanding access to Hospital Services
5.3.2 Expanding access to pharmaceutical services
5.3.3 Expanding access to laboratory services
5.3.4 Expanding access to radiology services
5.4 Cost coverage
Chapter 6 : Reorganisation of the Health Care System and Services under NHI
6.1 Service Delivery
6.1.1 Primary Health Care (PHC) Services
6.1.2 Implementation of Quality Improvement Initiatives
6.1.3 Improving access to Emergency Medical Services
6.2 Improving Leadership and Governance
6.2.1 Improving management and governance at PHC level
6.2.2 District Health Management Offices (DHMOs)
6.2.3 Health Promotion and the National Health Commission
6.2.4 Role, functions, management and governance of Central Hospitals
6.2.5 Role and management of other levels of public hospitals
6.2.6 Governance of other levels of public hospitals
6.3 Enhancing the Health Workforce
6.4 Medical products and technologies
6.4.1 Improving access to pharmaceutical services
6.4.2 Improving the efficiency of National Health Laboratory Services (NHLS)
6.5 Information and Research for Monitoring of progress to UHC
Chapter 7 : Finance of NHI
7.1 Aims of Health Financing Reform
7.2 Economic Environment
7.3 NHI Expenditure Projections: and Cost Estimates
7.3.1 NHI Expenditure Scenarios
7.3.2 Estimates of Public and Private Health Expenditure
7.4 Raising Revenue to Finance NHI
7.4.1 Economic growth and financing public health expenditure
7.4.2 Principles of tax design
7.4.2.1 Efficiency and Equity
7.4.2.2 Tax Mix
7.4.2.3 Progressivity
7.5 Options for public funding of NHI
7.5.1 Payroll taxes
7.5.2 Surcharge on taxable income
7.5.3 Value-Added Tax
7.5.4 Other possible tax instruments
7.5.5 Tax rate scenarios
7.6 Changing landscape of Intergovernmental Arrangements
7.7 Proofing of Revenue
7.8 Organisation of the NHI Fund
7.9 Governance of the NHI Fund
7.10 Containing costs and improving management
7.10.1 Supply-side measures
7.10.2 Demand-side measures
7.10.3 Public management and financing reforms
7.11 Linkages to Broader Social Security Reforms
Chapter 8 : Purchasing of Health Services
8.1 Purchaser-Provider Split
8.2 Accreditation of Providers by NHI Fund
8.3 Treatment Guidelines
8.4 Provider Payment Mechanisms
8.4.1 Provider Payment at Primary Health Care Level
8.4.2 Provider Payment for ambulatory private specialist services
8.4.3 Provider payment at hospital level
8.4.4 Payment for Emergency medical services (EMS)
8.5 NHI Information systems
8.6 Health Technology Assessment
8.7 The future role of Medical Schemes
Chapter 9 : Phased Implementation
Chapter 10 : Conclusion
References
Policy Guidelines for the Licensing of Residential and/or Day Care Facilities for Persons with Mental Illness and/or Severe or Profound Intellectual Disability
Notice No. 218 of 2018
Definitions
1. Introduction
2. Context
3. Purpose of Guidelines
4. Application of Guidelines
5. Legislative Framework
6. Guiding Principles
7. Licensing and Designation
8. Application Procedure
9. Handling of Applications
10. Granting or Refusal of License
11. Appeal Procedure
12. Cancellation of License
13. Renewal of License
14. Compliance and Monitoring
15. Rights of Mental Health Care Users
16. Facilities and Infrastructure Norms and Standards
17. Clinical Governance and Clinical Care
18. Clincal Support Services
19. Governance and Human Resources
Annexures
Annexure A : Application Form for Licensing of Residential and/or Day Care Facilities for Persons with Mental Illness and/or Severe or Profound Intellectual Disability
Annexure B : Norms and Standards for Licensing of Residential and/or Day Care Facilities for Persons with Mental Illness and/or Severe or Profound Intellectual Disability
Annexure C : Types of Services and Levels of Care for Residential and/or Day Care Facilities for Persons with Mental Illness and/or Severe or Profound Intellectual Disability
Annexure D : Assessment and Compliance Report for Residential and Day Care Facilities Providing Care, Treatment and Rehabilitation Services for Persons with Mental Illnesses and/or Severe or Profound Intellectual Disability
Proclamations
Commencement of section 53
Notice No. 22 of 2008
Commencement of Certain Sections of the National Health Act, 2003 (Act No. 61 of 2003)
Notice No. R. 20 of 2010
Commencement of the National Health Amendment Act, 2013 (Act No. 12 of 2013)
Notice No. 37 of 2013
Regulations relating to Human Stem Cells
Purchase
Notice No. R. 376 of 2007
Chapter 1
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R 385
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R 385
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