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COMPULSORY COMPETENCY MODULE: INTRODUCTION TO REGULATORY REQUIREMENTS FOR BIOMEDICAL TECHNICAL PERSONNEL (BTP) DEC 2020

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ONLINE TRAINING BY THE AUTHORITY

COMPULSORY COMPETENCY MODULE:
INTRODUCTION TO REGULATORY REQUIREMENTS FOR BIOMEDICAL TECHNICAL PERSONNEL (BTP)

 

        Date              :    9 December 2020 (Wednesday)      |   9.00 AM –  5.00 PM     (TRAINING)                    
                                   10 December 2020 (Thursday)         | 10.00 AM – 11.30 AM (EXAMINATION)

 

INTRODUCTION

This regulatory module is designed to provide participants with the knowledge of medical device regulatory requirements in Malaysia. Biomedical technical personnel, supervisors, and managers who responsible for maintenance, testing & commissioning and disposal of medical device in healthcare institutions and related facilities will highly benefit from this course.

 

OBJECTIVES

  • To provide an overview of the Medical Devices Act 737, and Medical Device Regulation 2012
  • To provide the medical device regulatory requirements in a healthcare institute

 

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

 

PROGRAMME OUTLINE

 

ONLINE TRAINING BY THE AUTHORITY: - COMPULSORY COMPETENCY MODULE:

INTRODUCTION TO REGULATORY REQUIREMENTS FOR BIOMEDICAL TECHNICAL PERSONNEL

Date (Day)

9 December 2020 (Wednesday)

Time

9:00 AM – 5:00 PM (TRAINING)

DAY 1

09:00am – 10:00am

Medical Device Act, 737

10:10am – 11:30am

Medical Device Regulation 2012

11:30am – 12:15pm

Licensing of Establishment

12:15pm – 13:00pm

Medical Device Registration Requirement

13:00pm – 14:00pm

Lunch Break

14:00pm – 14:45pm

Atomic Energy Licensing Act 1984  (Act 304)

14:45pm – 15:30pm

Medical Device Disposal MS 2650:2015

15:30pm – 16:15pm

Overview of Medical Device Regulatory Requirement in Healthcare Institution

16:15pm – 17:00pm

Post Market Regulation

DAY 2

Date (Day)

10 December 2020 (Thursday)        

Time

10:00 AM –  11:30 PM (EXAMINATION)

10:00am – 11:30pm

Online Examination at MDA

 

REGISTRATION AND TRAINING FEE

Training fee for per participant: RM 750

The closing date for registration is on 4th December 2020.

To register, please click HERE

  • Upon acceptance of the Registration, An invoice (for payment purpose) together with details of payment method will be issued accordingly
  • Registration of participants will be on a first-come-first-served basis.
  • Upon payment confirmation, MDA will provide a link to join the training program.

 

 

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: 20 November 2020.
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