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

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

 

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

 

PROGRAMME OUTLINE

TRAINING BY THE AUTHORITY: - COMPULSORY COMPETENCY MODULE:

INTRODUCTION TO REGULATORY REQUIREMENTS FOR BIOMEDICAL TECHNICAL PERSONNEL

Date (Day)

12 August 2020 ( Wednesday )

Time

8:00 AM – 5:00PM

Venue

MEDICAL DEVICE AUTHORITY, LEVEL G, PRIMA 9, PRIMA AVENUE II, BLOCK 3547, PERSIARAN APEC, 63000 CYBERJAYA 63000 CYBERJAYA

DAY 1

08:00am –  08:55am

Registration & Breakfast

09:00am –  10:15am

Medical Device Act, 737

10:15am – 11:30am

Medical Device Regulation 2012

11:30am – 12:00pm

Atomic Energy Licensing Act 1984  (Act 304)

12:00pm – 12:30pm

Medical Device Disposal MS 2650:2015

12:30pm – 13:00pm

Medical Device Classification

13:00pm – 14:00pm

Lunch Break

14:00pm – 15:00pm

Medical Device Registration Requirement

15:00pm – 15:30pm

Licensing of Establishment

15:30pm – 16:00pm

Overview of Medical Device Regulatory Requirement in Healthcare Institution

16:00pm – 17:00pm

Post Market Regulation

DAY 2

Date (Day)

13 August 2020 (Thursday)

9:00am – 10:30am

Examination

 

REGISTRATION AND TRAINING FEE

Training fee for per participant: RM 750

  • Inclusive of breakfast, lunch and refreshments (12 August 2020)
  • No meal will be provided on the examination day (13 August 2020)
  • Training fee does not include accommodation & travelling

Kindly complete the provided Registration Form and submit to trainingpackage@mda.gov.my. Upon acceptance of the Registration Form, An invoice (for payment purpose) together with details of payment method will be issued accordingly. The closing date for registration is on 3rd August 2020.

To register, please click HERE

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: 22 October 2020.
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