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

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 4^th 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.