This document provides information on regulatory requirements for medical devices and radiation services under the Atomic Energy Licensing Act 1984 in Malaysia. It begins with statistics on cancer in Malaysia and the percentage of patients requiring radiotherapy. It then outlines the legislative hierarchy for regulations in Malaysia and describes the Atomic Energy Licensing Act 1984 and its provisions. The document provides numerous guidelines, standards, and circulars issued over the years related to radiology, radiotherapy, and nuclear medicine. Checklists for license applications are also included.

1. 10/2/2020
1
Seksyen Perlesenan
Bahagian Kawalselia Radiasi Perubatan (BKRP)
Kementerian Kesihatan Malaysia
nurmazaina@moh.gov.my
perlesenan_bkrp@moh.gov.my
ATOMIC ENERGY LICENSING ACT 1984 (ACT 304)
RELATING WITH MEDICAL DEVICES
2
New cancer cases each year
New cancer cases per year in Malaysia by 2030
Leading cause of death in Malaysia
Malaysia Cancer Mortality Rate
Of patients with cancer require Radiotherapy
Treatment
37,000
>55,000
4th
61%
50-60%
Sources: Malaysian Study on Cancer Survival (MySCan), Malaysia National Cancer Registry (2007-2011), Malay
Mail (Dec 2018)
Radiation Therapy: The Malaysian Landscape
3
Sources: Globocan 2018, World Health Organization
Lung, 3426,
17%
Colorectum,
3342, 16%
Prostate,
1807, 9%
Nasopharynx,
1600, 8%
Liver,
1460, 7%
Others, 8984,
43%
New Cancer Cases 2018, Male
Breast, 7593,
33%
Colorectum,
2795, 12%
Cervix,
1682, 7%
Ovary, 1271
6%
Lung, 1260,
5%
Others, 8617,
37%
New Cancer Cases 2018, Female
4
5 6

2. 10/2/2020
2
Mandatory /
legally bound
Voluntary
Act
Regulations
Circulars/ Codes &
Standards/ Guidelines
Local Rules/ SOP/ Manual
Not regulatory by
itself but becomes
regulatory if linked
to Acts/ Regulations
Malaysian Legislative Hierarchy
Reg. 54 (1)
ATOMIC ENERGY LICENSING ACT 1984
(ACT 304)
Safeguard on the usage of ionizing radiation in
medicine
 Radioactive Substance Act 1968
• Based on the Radioactive Substance Act 1964; United
Kingdom.
 Atomic Energy Licensing Act 1984
• Repeals Radioactive Substance Act 1968
• Director General of Health continues to be the
appropriate authority for controlling the application of
radiation in medicine.
 Gazetted on 28 June 1984
 10 divisions
 71 section of written laws
Malaysian Legislative – the line-up 1968 - 2019 DESCRIPTON
Atomic Energy Licensing Board (AELB)
(Regulatory Authority)
YBRS. DR. MOHD NOR AZMAN
BIN HASSAN
Timbalan Ketua Setiausaha (S)
Kementerian Tenaga, Sains,
Teknologi, Alam Sekitar dan
Perubatan Iklim (MESTECC)
Private Government
Akta Perlesenan Tenaga Atom
1984 (Akta 304)
Sijil Lesen & Lampiran A
RADIA
Sijil Pendaftaran & Lampiran A
Registration (Pendaftaran)
License (Berlesen)
RADIA Kerajaan
Private vs Government
Hospital/ klinik swasta
IJN
Hospital Universiti
Hospital/ Klinik Kesihatan KKM
Hospital Angkatan Tentera

3. 10/2/2020
3
It covers:
(1) Facilities
(2) Equipment
(3) Personnel
(4) Practice
Regulatory Requirements – Act 304
Must follow all licensing requirements:
14
Akta 304 – S.12
15
Akta 304 – S.12
16
Akta 304 – S.13
17
Akta 304 – S.15
18
Akta 304 – S.16

4. 10/2/2020
4
19
Akta 304 – S.16
POLISI KKM
NO PEKELILING / GARIS PANDUAN / KRITERIA / MANUAL TAHUN
1. Minimum Power Requirements For Diagnostic X-ray Machine 1985
2. Acceptable Method Of Decommissioning Of X-ray Machine 1993
3. Circular on Employment of Trained X-Ray Operators By Private General Practitioners 1993
4. Guidelines To Obtain Class C License Under the Atomic Energy Licensing Act 1984 1994
5. Garis Panduan Bagi Menjalankan Prosedur Diagnosis Perubatan Menggunakan X-ray Bagi
Wanita Yang Disyaki Mengandung
1998
6. Keperluan Tambahan QAP Di Bawah Akta Perlesenan Tenaga Atom 1984 Bagi Institusi-Institusi
Perubatan Swasta – Pengamal Perubatan Swasta, GP’s
1999
Code & Standard/Guidelines/Circulars
NO PEKELILING / GARIS PANDUAN / KRITERIA / MANUAL TAHUN
7. Pekeliling Keperluan Tambahan Perlesenan Di Bawah Akta 304 Bagi Perkhidmatan Radiologi
Diagnostik Disediakan Oleh Institusi-Institusi Perubatan Swasta
1999
8. Kriteria Permohonan Lesen Kelas H (Persijilan) di bawah Akta 304 2000
9. Surat Pekeliling Kepada TKPK (Perubatan) & TKPK (Kesihatan Awam) Mengenai Keperluan
Tambahan Perlesenan Di Bawah Akta 304 Bagi Perkhidmatan RADIOLOGI DIAGNOSTIK Yang
Diberikan Oleh Institusi Perubatan Di Bawah Kementerian Kesihatan Malaysia
2001
10. Surat Pekeliling Kepada Pengarah (Perancangan & Pembangunan) Mengenai Keperluan
Tambahan Perlesenan Di Bawah Akta 304 Bagi Perkhidmatan RADIOLOGI DIAGNOSTIK Yang
Diberikan Oleh Institusi Perubatan Di Bawah Kementerian Kesihatan Malaysia
2001
11. Garis Panduan Bagi Menggunakan Radas Penyinaran Mobile X-ray 2005
12. Pekeliling Keperluan Pakar Perubatan Nuklear Bagi Perkhidmatan Perubatan Nuklear Di Bawah
Akta 304
2010
13. Pekeliling Keperluan Mendapatkan Khidmat Personel Berkelayakan Sebagai Pengendali Radas
Penyinaran Bagi Perkhidmatan Pergigian Di Bawah Akta 304.
2010
Code & Standard/Guidelines/Circulars
NO PEKELILING / GARIS PANDUAN / KRITERIA / MANUAL TAHUN
14. Guidelines for Management of Brachytherapy for Prostate Cancer Using Permanently Implanted Radioactive Sources. 2011
15. Keperluan Mendapatkan Khidmat Juru X-Ray Berkelayakan Sebagai Pengendali Radas Penyinaran Bagi Klinik Pengamal
Perubatan dan Institusi Perubatan Swasta Di Bawah Akta 304
2010
16. Penamatan Perkhidmatan Operator X-ray Terlatih Sedia Ada di Klinik Pengamal Perubatan dan Institusi Perubatan
Swasta di Bawah Akta 304 Bagi Maksud Perubatan.
2012
17. Penangguhan Tarikh Pelaksanaan Arahan Penamatan Perkhidmatan Operator X-ray Terlatih Sedia Ada di Klinik
Pengamal Perubatan dan Institusi Perubatan Swasta di Bawah Akta 304 Bagi Maksud Perubatan.
2013
18. Manual Pelaksanaan Program Penjaminan Mutu Perkhidmatan Radioterapi di Bawah Akta 304 Bagi Maksud Perubatan 2013
19. Manual Pelaksanaan Program Penjaminan Mutu Perkhidmatan Perubatan Nuklear di Bawah Akta 304 Bagi Maksud
Perubatan
2013
20. Garis panduan Malaysian Diagnostic Reference Levels In Medical Imaging (Radiology) 2013
21. Garis panduan Malaysian Diagnostic Reference Levels In Medical Imaging (Nuclear Medicine) 2013
Code & Standard/Guidelines/Circulars
NO PEKELILING / GARIS PANDUAN / KRITERIA / MANUAL TAHUN
22. Deraf Peraturan-Peraturan Perlesenan Tenaga Atom (Penggunaan Sinaran dalam Perubatan,
Pergigian dan Veterinar) 201_
- telah dimuktamadkan di peringkat Lembaga.
2013
23. Peringatan Bagi Penamatan Perkhidmatan Operator X-ray Terlatih Sedia Ada di Klinik Pengamal
Perubatan dan Institusi Perubatan Swasta di Bawah Akta 304 Bagi Maksud Perubatan.
2014
24. Standard Operating Procedures For Patients Undergoing Treatment of Iodine-131 In Nuclear Medicine
Department Under Ministry of Health Malaysia
2015
25. Pengekalan Perkhidmatan Operator X-ray Terlatih di Klinik Pengamal Perubatan dan Institusi
Perubatan Swasta Sedia Ada Sebagai Pengendali Radas Penyinaran di Bawah Akta 304 Bagi Maksud
Perubatan.
2015
Code & Standard/Guidelines/Circulars

5. 10/2/2020
5
NO PEKELILING / GARIS PANDUAN / KRITERIA / MANUAL TAHUN
26. Guidance Document on Radiological Emergency Preparedness for Medical Physicists 2015
27. Standard Operating Procedures for Patients Undergoing Treatment of Iodine 131 (I-131) in Nuclear
Medicine Department Under Ministry of Health di Bawah Akta Perlesenan Tenaga Atom 1984 (Akta
304) Bagi Maksud Perubatan
2015
28. Manual Pelaksanaan Program Penjaminan Mutu Perkhidmatan Radioterapi di Bawah Akta 304 Bagi
Maksud Perubatan – Pindaan Tahun 2016
2016
29. Guidance Document on the Safe Use of Medical Lasers 2016
30. Guideline for Occupational Radiation Protection in Medical Interventional Procedures 2016
31. Guidance Document for Occupational Radiation Protection 2016
Code & Standard/Guidelines/Circulars
NO PEKELILING / GARIS PANDUAN / KRITERIA / MANUAL TAHUN
32. Technical Quality Control Protocol Handbook for Computed Tomography System 2015
33. Technical Quality Control Protocol Handbook for Dental System 2015
34. Technical Quality Control Protocol Handbook for Fluoroscopy System 2015
35. Technical Quality Control Protocol Handbook for Radiography System 2015
36. Guidance Document on Radiological Emergency Preparedness for Medical Physicist 2016
37. Guidance Document for Occupational Radiation Protection Radiological Practice 2016
38. Guideline for Occupational Radiation Protection in Medical Interventional Procedures 2016
39. Manual Pelaksanaan Program Jaminan Kualiti (QAP) Dalam Perkhidmatan Radiologi 2017
Code & Standard/Guidelines/Circulars
NO PEKELILING / GARIS PANDUAN / KRITERIA / MANUAL TAHUN
40. Manual Pelaksanaan Program Jaminan Kualiti (QAP) Dalam Perkhidmatan Perubatan Nuklear Edisi 2 2017
41. Pekeliling Keperluan Latihan Untuk Personel Dalam Perkhidatan Perubatan Nuklear di Bawah Akta
Perlesenan Tenaga Atom 1984 (Akta 304)
2017
42. Garis Panduan Penganjuran Latihan Khas Operator X-ray Terlatih Sedia Ada Kategori 2 di Bawah Akta
Perlesenan Tenaga Atom 1984 (Akta 304) Bagi Maksud Perubatan
2017
43. Garispanduan Penyediaan Manual Program Perlindungan Sinaran (PPS) Bagi Fasiliti Perubatan 2017
44. Standard Operating Procedures Fro Radioactive Material Inventory Management in Nuclear Medicine
Department
2017
45. Technical Quality Control Protocol Handbook for SPECT, PET and Non Imaging 2017
46. Kriteria Bagi Permohonan Rayuan Untuk Pengambilan Semula Perkhidmatan Operator X-Ray Terlatih
Sebagai Pengendali Radas Penyinaran Di Institusi Perubatan Dan Klinik Pengamal Perubatan Swasta
Sedia Ada Di Bawah Akta Perlesenan Tenaga Atom 1984
2017
Code & Standard/Guidelines/Circulars
NO PEKELILING / GARIS PANDUAN / KRITERIA / MANUAL TAHUN
47. Garis Panduan Pengurusan Pesakit Yang Menjalankan Rawatan Permanent Seed Implant
Brachytherapy Bagi Institut Perubatan di Malaysia di Bawah Akta Perlesenan Tenaga Atom 1984 (Akta
304) Bagi Maksud Perubatan
2018
48. Pindaan Garis Panduan Permohonan Pendaftaran Kemudahan Sinaran Mengion Bagi
PerkhidmatanRadiologi Diagnostik di Fasiliti Perubatan Kerajaan
2018
49. Tatacara Pelupusan Radas Penyinaran dan Peranti Yang Menggunakan Bahan Radioaktif Selaras
Dengan Ketetapan di Bawah Akta Perlesenan Tenaga Atom 1984 (Akta 304)
2018
50. Manual Pelaksanaan Program Jaminan Kualiti (QAP) Dalam Perkhidmatan Radiologi – Pindaan
Januari 2019
2019
Code & Standard/Guidelines/Circulars
Class A Bahan radioaktif
Class B Bahan Nuklear
Class C Radas Penyinaran
Class D Mengangkut
Class E Import & eksport
Class F Pemasangan Nuklear
Class G Stor & lupus Bubarkan
Class H Aktiviti2 tidak diliputi A-G
DESCRIPTION
Reg. 3 of Licensing Regulations 1986
30
Akta 304 – S.17

6. 10/2/2020
6
Conditions of the license (Section 17 of Act 304)
 One piece of document
produced after a license has
been issued by the appropriate
authority (DG of Health
Malaysia).
 Bind to law.
 All itemized specify by this
document is direct orders to the
licensed holder.
1) New license
2) Renewal of a license
3) Amendment of a license
3 categories of license application
(Radiology, Radiotherapy, Nuclear Medicine)
CATEGORY 1:
Peraturan Perlindungan Sinaran (Perlesenan) 1986

7. 10/2/2020
7
1. Contoh-contoh pelan hospital yang telah diluluskan
2. Contoh laporan pengiraan perisaian bilik X-ray yang
disahkan oleh Juruperunding Fizik Perubatan
3. Contoh laporan Lead Equivalent Test bagi bilik OT
4. Contoh pelan bilik MRI
39 40
41 42
1) Pemohon perlu menunjukkan
kedudukan fixed metal detector.
2) Kedudukan bilik MRI tidak
bersebelahan dengan bilik CT
Scan/bilik radas penyinaran yang lain
yang boleh menyebabkan interferens
dan bagi memastikan keselamatan
peralatan.
3) Laluan pesakit ke bilik MRI tidak
boleh berkongsi dengan laluan
pesakit ke bilik lain.

8. 10/2/2020
8
1) Keperluan Am
2) Personnel
3) Perihal radas yang akan dipasang
4) Perihal processing image
5) Perihal pelan premis (Layout plan)
6) Perihal bilik X-ray (Detailed plan)
7) Program perlindungan sinaran
8) SOP
9) Quality Assurance Program (QAP)
10)Ulasan keseluruhan
Senarai Semak Radiologi
1) Keperluan Am
2) Personnel
3) Perihal radas yang akan dipasang
4) Perihal bahan radioaktif (termasuk site security plan, jika berkenaan)
5) Perihal pelan premis (Layout plan)
6) Perihal bilik X-ray (Detailed plan)
7) Program perlindungan sinaran
8) SOP
9) Quality Assurance Program (QAP)
10)Ulasan keseluruhan
Senarai Semak Radioterapi dan Perubatan Nuklear
• Using application form (LPTA/BP/3) or pink form,
(shall be completed, signed & returned to Bahagian
Kawalselia Radiasi Perubatan, MOH, Putrajaya)
• 3 basic documents : 1) (LPTA/BP/3) ; 2) license fee
with RM15 application/ process fee; and 3) copy of
current APC to process the document
Step
1
• When the requirements are:
• Fulfilled : “S/G” license issued by DG of Health
• Partly Fulfilled: “S” license only will be issued by
DG of Health
Step
2
CATEGORY 2: Application for renewal of a license

9. 10/2/2020
9
Store/
Use
license
QC and summary
report by H Class
license
(Consultant
Medical Physicist)
Medical
report
Using
LPTA/BM/5
(Section A)
Audit
radiograph
Training /CME
(license holder&
supervisor, etc)
FRRA
To get “S/G” license…..
(Radiology)
Medical report
LPTA/BM/5 (Section A)
Price: RM10 per worker
For dental &
veterinary use; the
calibration report is
acceptable
With qualified personnel
Store/
Use
license
QC and summary
report by H Class
license/ in-house
with vendor as
approved by KKM
Medical
report
Using
LPTA/BM/5
(Section A)
Training/CME
(license holder&
supervisor, etc)
Indicator
Other
documents
To get “S/G” license…..
(Radiotherapy/ nuclear medicine)
Medical report
LPTA/BM/5 (Section A)
Price: RM10 per worker
With qualified personnel
RT: The rate of discrepancies of
treatment verification images
NM: 1. Rate of repeat studies
2. Rate of repeat CT exposure
for hybrid imaging
1) Change of address which involve the
transfer of the location of the apparatus
2) Purchase of new/additional apparatus
3) Selling of apparatus already licensed
Category 3: Application for Amendment
of a License
• Refer Checklist
1. Change
of address
Category of amendment

10. 10/2/2020
10
• Refer Checklist
2.
Purchase of
new/
additional
apparatus
Category of amendment
• Refer Checklist
3.
Selling of
apparatus
Category of amendment

11. 10/2/2020
11
• Rujuk Surat Pekeliling Ketua
Pengarah Kesihatan
Disposal or
Change X-
ray Tube??
Category of amendment
PROSES ALIRAN
KERJA
• Regulation 14 of Licensing
Regulations 1986
• Refer Checklist
Change of
license
holder??
Category of amendment

12. 10/2/2020
12
• Section 22(1) (c) of Act 304
• Regulation 78 of BSRP 2010
• Inform in written to appropriate authority –
intention letter from license holder
• Borang A and Borang B (Pelupusan)
• Borang E from CKAPS (if close clinic)
• Original license and Lampiran A
Cessation of
operations??
Category of amendment
Keperluan Tambahan Khusus Keperluan Tambahan Khusus
Keperluan Tambahan Khusus Keperluan Tambahan Khusus
Permohonan radas mobile
c-arm bagi tujuan klinikal
untuk tempoh singkat
(demo)

13. 10/2/2020
13
1. PERMOHONAN LESEN BARU BAGI RADAS PENYINARAN
2. PERMOHONAN PEMBAHARUAN LESEN RADAS PENYINARAN
3. PERMOHONAN MENGGUNA RADAS PENYINARAN
4. PERMOHONAN PENGGANTIAN ATAU PENAMBAHAN RADAS
PENYINARAN SEDIA ADA
5. PERMOHONAN PEMINDAHAN RADAS PENYINARAN SEDIA ADA/
PREMIS
6. PERMOHONAN PENJUALAN RADAS PENYINARAN SEDIA ADA
7. PERMOHONAN PELUPUSAN RADAS PENYINARAN/ TIUB X-RAY
SEDIA ADA
8. PERMOHONAN PENUKARAN NAMA PEMEGANG LESEN
SENARAI SEMAK RADIOLOGI KEPADA PEMOHON
74
Thank You
For your attention
NURMAZAINA MD ARIFFIN
Ketua Penolong Pengarah Kanan
Seksyen Perlesenan
Bahagian Kawalselia Radiasi Perubatan (BKRP)
Kementerian Kesihatan Malaysia
nurmazaina@moh.gov.my
perlesenan_bkrp@moh.gov.my