TRAINING (PHYSICAL)

        Date         :    7 September 2022 (Wednesday) |  9.00 AM – 5.00 PM

        Venue       :    Bilik Meranti, Level 6, Medical Device Authority

 

  EXAMINATION (ONLINE)
        Date         :    8 September 2022 (Thursday)      | 10.00 AM – 12.00 PM

        Platform   :    MDA Training Portal & Zoom

 

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TRAINING OVERVIEW

 

This module is designed in line with Section 43 of the Medical Device Act 737 for participants who are responsible for maintenance, testing & commissioning, and disposal of a medical device in healthcare institutions and related facilities.

In this training, participants will gain essential information on medical device regulatory requirements and other relevant regulations that are required to carry out medical device usage and operations safely.

 

 

TRAINING INSIGHTS

 

  • 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
  • To enlighten on the importance of compliance with standards.

 

 

TARGET AUDIENCE

 

Biomedical Technical Personnel

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

 

PROGRAMME OUTLINE

 

TRAINING BY THE AUTHORITY:

INTRODUCTION TO REGULATORY REQUIREMENTS FOR BIOMEDICAL TECHNICAL PERSONNEL

Date (Day)

7 SEPTEMBER 2022 (WEDNESDAY)

Time

9:00 AM – 5:00 PM

Venue

Bilik Meranti, Level 6, Medical Device Authority

DAY 1

08:50am – 09:00am

Briefing

09:00am – 09:10am

Welcoming Remarks

09:10am – 10:30am

Overview of Medical Device Regulatory System in Malaysia
(Pre-Market, Placement on Market & Post-Market)

10:30am – 10:40am

Short Break

10:40am – 12:30pm

Run-through on MS2058:2018 Good Engineering Maintenance Management of Active Medical Devices

12:30pm – 14:00pm

Lunch Break

14:00pm – 15:00pm

Requirements Atomic Energy Licensing Act 1984 (Act 304)

15:00pm – 16:00pm

Medical Device Disposal MS 2650:2015

16:00pm – 17:00pm

Medical Device and the Healthcare Institution

DAY 2

Date (Day)

8 SEPTEMBER 2022 (THURSDAY)

Time

10:00 AM – 12:00 PM (ONLINE EXAMINATION)

Platform  

MDA Training Portal & Zoom

10:00am – 12:00pm

Online Examination

 

REGISTRATION AND TRAINING FEE

 

Training fee: RM 800/Pax

The closing date for registration is on 30th August 2022.

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.

 

Updated: 26th July 2022