MINISTRY OF HEALTH MALAYSIA

Dr. Afidah Ali, MMC: 31597

MD (USM) 1994, MPH (USM) 2002, No. NSR 127830
Deputy Director (CKAPS)
Medical Practice Division

Islamic Dental Association of Malaysia (IDAM)

2020 Annual Conference & AGM

19 JANUARY 2020
Credit Guarantee Corporation (CGC) Petaling
Jaya, Selangor DE
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 OBJECTIVES
 To understand the legal requirements under Act 586 and its
regulations in relation to private dental facilities and services
in Malaysia
 To understand the concepts and regulations for private
dental clinics setting in Malaysia.
 To recognise the differences between Act 586 versus Act 51/
804
 CONTENTS

INTRODUCTION
LAW REGULATING PRIVATE SECTOR
MOH & CKAPS
CLOSURE
CLASSIFICATION OF PRIVATE
HEALTHCARE
LAWS IN MALAYSIA FACILITIES & CONCLUSION
LAWS REGULATING SERVICES ACT 1998 Q&A
[ACT 586]
HEALTHCARE
ACT 586 VS
ACT 51/ ACT 804
 MINISTER OF HEALTH
Deputy Minister
SECRETARY GENERAL

DIRECTOR GENERAL OF HEALTH

Deputy Secretary Deputy Director DEPUTY DIRECTOR Deputy Director Principal Principal Principal Deputy
General General (Public GENERAL General (Research Director (Oral Director Director (Food Secretary
(Management) Health) (MEDICAL) & Technical Health) (Pharmaceutical Safety & General
Support) Services) Quality) (Finance)

INSTITUTIONS Medical MEDICAL TCM Division Nursing Allied STATE HEALTH

RESEARCH CENTRE Development PRACTICE DEPARTMENTS
AUTHORITIES
Division Health
Division DIVISION Division ADMINISTRATIVE
ROLES

MALAYSIAN MEDICAL MEDICO-LEGAL LEGISLATION

TECHNICAL
PRIVATE MEDICAL PRACTICE ROLES
OPTIC COUNCIL ASSISTANTS SECTION (CML) SECTION (CGA)
CONTROL SECTION (CKAPS HQ)
CKAPS JKN/WP
(MOM) BOARD (LPP)
Note: HEALTHCARE IN MALAYSIA ~ DUAL SYSTEMS: PUBLIC AND PRIVATE
Sektor Polisi, Sektor Sektor
 PUBLIC UNDER MINISTRY (GENERAL ORDER & TREASURY ORDER) Pendaftaran & Aduan &
Sumber & Teknikal & Penilaian
 PRIVATE UNDER ACT 586 Pelesenan Penguatkuasaan
Piawaian Operasi Perkhidmatan
INTRODUCTION:

LAWS GOVERNING
HEALTHCARE

 HEALTHCARE
PROFESSIONAL

 MEDICAL
PRACTICE

 HEALTHCARE
FACILITIES &
SERVICES
 CIVIL VERSUS CRIMINAL LAWS
CRIMINAL LAW
CIVIL LAW
 Law deals with crime and the legal punishment
 Law deals with the disputes between individuals, of criminal offences, using criminal laws,
organizations, or between the two, using private between individuals and the Government.
laws, in which compensation is awarded to the
victim.
 Action taken by the Government (individuals
 Case filed by private party/individual have no power).

 Standard of proof: “Preponderance of evidence”.  Standard of proof: beyond reasonable doubt

Claimant must produce evidence beyond (tanpa keraguan munasabah)
balance of probabilities (pertimbangan
kebarangkalian).
 Burden of proof: “Innocent until proven quilty”
 Burden of proof, Claimant must give proof The prosecution must prove defendant quilty.
however the burden may shift to the defendant
in situations of Res Ipsa Loquitur (The thing
speaks for itself).  A guilty defendant is subject to non-custodial
punishment (fines or community service) or
 Type of punishment: Compensation (usually custodial (imprisonment) or in certain cases,
financial) for injuries or damages, or an cane strokes, and death penalty.
injunction in nuisance.
 LAWS GOVERNING HEALTHCARE PROFESSIONAL & PARA
PROFESSIONAL
Medical Act 1971
[Act 50]
Malaysian Medical Controlled by its own
Council
Council or Board
Dental Act 1971 Malaysian Dental
[Act 51] Council
Registration of
Malaysian Pharmacy
Optical Act 1991 Malaysian Optic Pharmacists Act 1951
[Act 469] Council Board
[Act 371]

Allied Health Professional Malaysian Allied Health Nurses Act 1950 Malaysian
Traditional & Complementary Malaysian TCM
Medicine Act 2016 [Act 775] Council Act 2016 [Act 774] professionals Council [Act 14] Nursing Board

Midwives Act 1966 Malaysian Midwife

Estate Hospital Assistants
Estate Hospital [Act 436] Board
(Registration) Act 1965
Assistant Board
(Revised 1990) [Act 435]

Medical Assistants
Medical Assistant
Technical staff/ Personnel care (Registration) Act 1977
Act 586 Board
aides etc [Act 180]
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 LAWS RELATED TO Healthcare PRACTICE (EXAMPLES)
Regulation and Control of Practise
Consent and Causing miscarriage
telemedicine
Telemedicine Act 1997 [Act 564] Penal Code [Act 574]

Drugs & Medicines Therapeutic, Medical Education &

Poisons Act 1952 (Revised 1989) [Act 366] Research
Dangerous Drugs Act 1952 (Revised 1980) [Act 234]
Human Tissues Act 1974 [Act 130]
Sale of Drugs Act 1952 (Revised 1989) [Act 368]

Health & Welfare of Children Food safety

Health Promotion Programmes and Activities
Food Act 1983 [Act
Malaysian Health Promotion Board Act 2006 Child Act 2001 [ Act 611] 281]
[Act 651]
Infectious Diseases Control
Advertisements
Destruction of Disease-Bearing Insects Act 1975 [Act 154]
Medicines (Advertisements and Sale) Act 1956 (Revised
1983) [Act 290] Prevention and Control of Infectious Diseases Act 1988
[Act 342]
Fumigation of premises
Psychiatric Services
Hydrogen Cyanide (Fumigation) Act 1953 (Revised 1981) [Act 260]
Mental Health Act 2001 [Act 615]
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 LAWS GOVERNING
HEALTHCARE FACILITIES & SERVICES
PRIVATE HEALTHCARE FACILITIES & SERVICES ACT 1998

Medical Device Act 2012

THE ATOMIC ENERGY

LICENSING ACT 1984

FACTORIES AND MACHINERY ACT, 1967 Pathology Laboratory Act 2007

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 Act 586
Private Healthcare Facilities &
Services Act 1998 & its subsidiaries
legislation

3 IMPORTANT WORDS
1. Healthcare Facilities (Including
equipment)
2. Healthcare Services
3. Personnel – all healthcare &
healthcare related professional,
para-professional & technical etc.

control: REGISTRATION & LICENSING

REGULATE: ENFORCEMENT
 DEFINITION: SECTION 2, ACT 586
 “Healthcare facility” means any “Healthcare services “includes-
premises in which one or more  Medical, Dental, Nursing, Midwifery, Allied Health,
members of the public receive Pharmacy and Ambulance Services and any Other
Service Provided by a Healthcare Professional;
healthcare services;  Accommodation for the purpose of any services
provided under this Act;
 Any service for screening, diagnosis, or treatment of
person suffering from, or believed to be suffering from,
 “Government healthcare facility” any disease, injury or disability of mind or body;
means any facility used of intended to  Any service for preventive or promotive health
purposes;
be used for the provision of healthcare  Any service provided by any healthcare para-
professional;
services established, maintained,  Any service for curing or alleviating any abnormal
operated or provided by the condition of the human body the application of any
apparatus, equipment, instrument or device or any
Government but excludes privatised other medical technology; or
or corporatized Government  Any health- related services;

healthcare facilities
Quality of being honest & having strong
moral principle or unity or togetherness Act 586
OBJECTIVES BASIC PRINCIPLES ACT 586
1. Impose and ensure minimum standards in 3 IMPORTANT WORDS
the private healthcare facilities and services.
1. Healthcare Facilities (Including
2. Ensure integrity among healthcare
professionals. equipments)
3. Ensure professionalism among all healthcare 2. Healthcare Services
professions. 3. Healthcare Personnel – all healthcare
4. Ensure quality of healthcare facilities and & healthcare related professional,
services e.g. Quality Assurance, Mortality para-professional & technical etc.
Review etc.
5. Address social and national interest. The competence or skilled expected
MAIN FOCUS: of a professional
TO SAFEGUARD PATIENTS’ INTEREST & ENSURE
PATIENTS RECEIVE SAFE TREATMENT
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 ACT 586 & SUBSIDIARY LEGISLATIONS
Private Healthcare Facilities & Services 3. Private Healthcare Facilities & Services
Act 1998 [Act 586] (1 May 2006) (Official Identification Card) Order, 2006 [P.U.
(A) 139/2006] (1 May 2006)
1. Private Healthcare Facilities & Services
(Private Medical Clinics or Private Dental 4. Private Healthcare Facilities & Services
Clinics) Regulations, 2006 [P.U. (A) 137/2006] (Private Hospitals and Other Private
Healthcare Facilities) (Amendment) Order,
– 14 Parts with 109 Regulations 2013 [P.U. (A) 358/2013] (17 December 2013)
& 7 Schedules (1 May 2006) & 2016 [P.U. (A) 260/2016] (15 Oktober 2016)

2. Private Healthcare Facilities & Services 5. Private Healthcare Facilities & Services
(Private Hospitals and Other Private (Compoundable Offences) Regulations, 2011
Healthcare Facilities) Regulations, 2006 [P.U. [P.U. (A) 170/2011] (1 August 2011)
(A) 138/2006] REPLACED BY Private Healthcare Facilities &
Services (Compoundable Offences)
– 29 Parts with 434 Regulations Regulations, 2017 [P.U. (A) 227/2017] (1
& 13 Schedules (1 May 2006) August 2017)

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 REGULATORY FRAMEWORK UNDER ACT 586
TIME BEFORE OPERATION CERTIFICATE ON OPERATION AFTER CLOSURE

Requirement Comply with Section 3 and 4, Act 586 Comply with Act 586 and its subsidiary legislations

Form B/C; Form Amendment Form D (to Duplication Form E (to

Registration Form A Inspection NA Preserve Patient
F/G Form B/C; F/G transfer) (From B, F, C, G) dispose)
Clinics Medical Record
Approval
/Patient Care Data
Procedure
Zoning (No Form 5 Amendment Duplication (Limitation Act
Form 1 Licence Renewal Form 8 (to Form 9 (to 1953 [Act 254])
Licensing Objection Form 3 Inspection Form 4/7 Inspection (Extension - Form (Form 2, 10, 4,
letter)
(Form 2) (every 2 years) transfer) dispose)
Form 6) 4/7/6/2/10 7, 6)
PHFS

Private dental clinic Written policies,

stds, procedures Statistical/
Surveillance/ Private hospital G/lines & Data/
Grievance
Incident
Assessable Social or
NA Mechanism Death Committees Welfare NA
Monitoring
Private ambulatory care centre Quality
Assurance
Information
Submission
(Complaint Mx)
Reporting
Notification Contribution

Private Mixed HC facilities Programme

Approval Procedure
Regulate/
Approval Procedure Show Cause YB MK's Board of Register
Control Section 112 Written Notice DG's Directive MDAC
Notice Directive Visitors

Undercover, Raid (with/without warrant); Investigation; Prosecution

Enforcement & Compound
Action
NA Warning/Direction/Temporary Closure; NA
Suspend or Revoke the Approval, Licence or Registration

Liable Certificate Holder / Licensee; or Person in Charge Certificate Holder /

Any person Licensee/Any person
person (unless specified)
 Approvals needed for the HEALTHCARE FACILITIES &
SERVICES from different agencies
ACT REGULATE

Private Healthcare Facilities & Services Act 1998 [Act 586] - MOH Healthcare Facilities & Services & its related matters

The Atomic Energy Licensing Act 1984 [Act 304] - MOH Radioactive material, nuclear material/ prescribed substance

Factories and Machinery Act, 1967 [64/1967] By Steam Boiler, Unfired Pressure Vessel + machinery
Department of Occupational Safety and Health equipments e.g. Autoclave, lift

Land, Certificate of Completion and Compliance of buildings

Uniform Building By-Laws 1984 By Local Authorities
or equivalent & signboard approval

Fire Services Act 1988 [Act 341] By Fire Department Safety for fire exit
Environmental Quality Act 1974 [Act 127] By Department
Environment safety & Clinical Waste Management
of Environment
Workers’ Minimum Standards of Housing and Amenities
Healthcare Facilities For estate workers
Act 1990 [Act 446] – Human Resource Ministry

Medical Device Act 2012 [Act 737]-MDA Medical devices

Pathology Laboratory Act 2007 [Act 674] - MOH Pathology Laboratory (yet to be enforced)
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REFERENCES: APPLICATIONS’
PROCEDURES
 All procedures are based on Act 586
and its Regulations including
applications procedures.

 Guidelines and checklists of all types

of applications on different type of
healthcare facilities can be
downloaded at Medical Practice
Division’s website
http://medicalprac.moh.gov.my

 Guidelines and checklists available in

accordance to the type of healthcare
facilities.
 DIFFERENCES: ACT 586 VS ACT 51/ 804
ACT 586 ACT51/ACT 804
Preamble An Act to provide for the regulation and An Act to provide for the establishment of the
control of private healthcare facilities Malaysian Dental Council and the Malaysian
and services and other health-related Dental Therapists Board, to provide the
facilities and services and for matters registration of dental surgeon and dental
related hereto. therapist, to regulate the practice of dentistry
and for the related matters
Scope Private Healthcare Facilities & Services Healthcare Professional (both public & private)
Agency Ministry of Health (CKAPS) Council or Board
Reference Law Ethic and professionalism
Regulatory DG and/or court Disciplinary Proceeding
Mechanism In court: Lawyer and judges Peer review

Others
IMPLEMENTATION AND ENFORCEMENT UNDER ACT 586: CROSS-REFER
NUMBER OF PRIVATE DENTAL CLINICS REGISTERED UNDER
ACT 586 BY STATES (AS OF 31 DEC 2019)
2000
1800
1600
32.6% 816
1400
1200
1000 521 DISPOSED
800 17.5% 439 2506 REGISTER
600 11.1%
3027 TOTAL
400 279 182 141
200 129 99
88 64 59 79 68 52
0 8 3
NUMBER OF LICENSED PHFS WITH DENTAL SERVICES IN MALAYSIA
(AS OF 31 DEC 2019)
PHFS + Dental Services

45
40
35
30
25 42 PHFS + Dental Services
20
15
10
5 4 1
0
Hospital ACC Mixed HCF
NUMBER OF COMPLAINTS RECEIVED TOWARD PHFS & PDC
(AS OF 31 DEC 2019)

100%
99% 9
3% 4%
22
98% 21
5%
20 5%
97% PDC
96% TOTAL
95% 337
516
94% 407 386
93%
92%
2016 2017 2018 2019
NUMBER OF COMPLAINTS BY CATEGORY (AS OF 31 DEC 2019)
25
0 0
20 3 2 2
2
15
FACILITY
10 19
0 PERSONEL
19 22
5 SERVICES
9
0
2016
2017
2018
2019
 NUMBER OF CASES: PHFS WITH DENTAL SERVICES (AS OF 31 DEC 2019)
**YEAR PROVISION NUMBER OF CASE *FOREIGNER TYPE OF CASE PENALTY/STATUS
Subsection 4(1) 9 1 Fake braces RM6K-250K
2016
Para 31(1)(c) 2 1 Bogus dentists + others RM30K – RM325K

Subsection 4(1) 13 3 Fake braces + Service RM200 – RM300K

2017
Para 31(1)(c) 1 1 Bogus dentists RM30K

Subsection 4(1) 13 3 Fake braces RM40K-70k

2018 Para 31(1)(c) 2 - Bogus dentists RM20K- RM30K

Subsection 39(1) 2 - Scope of services RM20K

2019 Subsection 4(1) 3 - Fake braces IN PROCESS

*OFFENCES BY UNREGISTERED (DENTAL PRACTITIONER) FOREIGNERS

** YEAR OF ENFORCEMENT ACTIVITY
 CONCLUSION
1. Private Healthcare Sector is governed by Act 586 and its Regulations to provide
minimum standards for the private healthcare facilities including private dental
clinics. It allows innovation and creativity (ethical and professional).

2. Healthcare is complex and it is governed by many laws under different authorities.

Involving many categories of professionals. The main purpose of governing laws for
healthcare sector is to ensure the patients’ safety and quality of healthcare.

3. All healthcare providers including the dental practitioners and all personnel involved
have no excuse to be ignorant of the laws and its consequences. It is now, the time to
make it compulsory for all healthcare providers including the dental practitioners to
understand the relevant laws.
THANK YOU Telephone: 03-8883 1039/1307
Fax: 03-8883 1040/8881 0901
E-mail: ckaps@moh.gov.my; ckaps.aduan@moh.gov.my
Online applications: http://medpcs.moh.gov.my
Website: http://medicalprac.moh.gov.my
Incident Reporting & Assessable Death: irad@moh.gov.my
FB: CKAPS_KKM
TWITTER: ckaps_kkm
INSTAGRAM: ckaps_kkm

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