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TRAINING BY THE AUTHORITY : COMPULSORY COMPETENCY MODULE : INTRODUCTION TO REGULATORY REQUIREMENTS FOR BIOMEDICAL TECHNICAL PERSONNEL APR 2020

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TRAINING BY THE AUTHORITY: -
COMPULSORY COMPETENCY MODULE:
INTRODUCTION TO REGULATORY REQUIREMENTS FOR BIOMEDICAL TECHNICAL PERSONNEL

Date              :    20 April 2020 (Monday)                    |   8.00 AM – 5.30 PM      (TRAINING)                    
                          
21 April 2020 (Tuesday)                    |   9.00 AM – 10.30 AM   (EXAMINATION)

Venue           :     MEDICAL DEVICE AUTHORITY, BILIK MERANTI, LEVEL6, PRIMA 9, PRIMA AVENUE II, BLOCK 3547, PERSIARAN APEC, 63000 CYBERJAYA

INTRODUCTION

This regulatory module is designed to provide participants with the knowledge on medical device regulatory requirements in Malaysia. Biomedical technical personnel, supervisors and managers responsible for maintenance, testing & commissioning and disposal of medical device in Healthcare Institution and related facilities will benefit from this course. Participants will gain an overview of the requirements of the Medical Device Regulation, Private Healthcare Act 586, Atomic Energy Licensing Act 304, Occupational Safety and Health Act 514, and Disposal.

OBJECTIVES

  • Obtain an overview of the Medical Devices Act 737, Act 586, Act 304, Act 514 and Disposal
  • Understand the medical device regulatory requirements in healthcare and related

TARGET AUDIENCE

  • Biomedical Service Provider
  • Biomedical Technical Personnel
  • Biomedical Engineering Trainers
  • Biomedical, Mechanical, Mechatronics, Electrical, Electronics Engineering graduates
  • Technical and Vocational Education and Training (TVET)
  • BEM and FEM Managers
  • Lecturers

TENTATIVE

TRAINING BY THE AUTHORITY: - COMPULSORY COMPETENCY MODULE: INTRODUCTION TO REGULATORY REQUIREMENTS FOR BIOMEDICAL TECHNICAL PERSONNEL

Date (Day)

20 April 2020 (Monday)

Time

8.00 AM – 5.30 PM

Venue

 

MEDICAL DEVICE AUTHORITY, BILIK MERANTI , LEVEL 6, PRIMA 9, PRIMA AVENUE II, BLOCK 3547, PERSIARAN APEC, 63000 CYBERJAYA 63000 CYBERJAYA

      TENTATIVE - DAY 1

8.00am   –   8.55am

Registration & Breakfast

9.00am   – 11.00am

Medical Device Act 2012, Act 737

11.00am – 11.15am

Refreshment

11.15am – 12.45pm

Private Healthcare Act, Act 586

12.45pm – 2.00pm

Lunch

2.00pm   – 3.00pm

Atomic Energy Licensing Act, Act 304

3.00pm   – 4.00pm

Occupational, Safety and Health Act, Act 514

4.00pm   – 5.00 pm

Disposal of Medical Device Requirements

5.00 pm  – 5.30 pm

Afternoon tea, End of Session

TENTATIVE -  DAY 2

Date (Day)

21 April 2020 (Tuesday)

Time

9.00 AM – 10.30 AM

9.00am - 10.30am

Examination

 

 

REGISTRATION AND TRAINING FEE

Training fee for per participant: RM 750

  • Inclusive of refreshments, lunch (20 April 2020), training materials, examination & certificate.
  • No meal will be provided on the examination day (21 April 2020)
  • Training fee does not include accommodation & travelling

Kindly complete the provided Registration Form and submit to trainingpackage@mda.gov.my. An invoice (for payment purpose) will be issued accordingly, upon the acceptance of the Registration Form. The closing date for registration is on 10th April 2020.

To register, please click HERE

Should you have any enquiries, please do not hesitate to email us at trainingpackage@mda.gov.my

Print

  Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb@mda.gov.my

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  • Last Modified: 28 March 2020.
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