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ONLINE TRAINING BY THE AUTHORITY

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

 

Date  9 March 2022 (Wednesday) |   9.00 AM – 5.00 PM    (TRAINING
Date 10 March 2022 (Thursday)     | 10.00 AM – 12.00 PM (EXAMINATION)

 

TRAINING OVERVIEW

Medical Device Authority is pleased to announce the revised Compulsory Competency Module for Biomedical Technical Personnel on Introduction to Regulatory Requirements. This module is intended for participants who are responsible for maintenance, testing & commissioning, and disposal of a medical device in healthcare institutions and related facilities. It provides participants with essential information on medical device regulatory requirements and other relevant regulations besides covering the segmentation of standards pertaining to Medical Devices in Malaysia.

 

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

ONLINE TRAINING BY THE AUTHORITY: - COMPULSORY COMPETENCY MODULE:

INTRODUCTION TO REGULATORY REQUIREMENTS FOR BIOMEDICAL TECHNICAL PERSONNEL

Date (Day)

9 MARCH 2022 (Wednesday)

Time

9:00 AM – 5:00 PM (ONLINE TRAINING)

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

16.00 – 17:00pm

Medical Device and the Healthcare Institution

DAY 2

Date (Day)

10 MARCH 2022 (Thursday)

Time

10:00 AM – 12:00 PM (EXAMINATION)

10:00am – 12:00pm

Online Examination

 

REGISTRATION AND TRAINING FEE

Training fee for per participant: RM 800

The closing date for registration is on 28th February 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.