COMPULSORY COMPETENCY MODULE: INTRODUCTION TO REGULATORY REQUIREMENTS FOR BIOMEDICAL TECHNICAL PERSONNEL (BTP) MARCH 2021

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

        Date              :    17 March 2021 (Wednesday)    |   9.00 AM – 5.00 PM     (TRAINING)                    
                                   18 March 2021 (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

 

TENTATIVE

ONLINE TRAINING BY THE AUTHORITY: - COMPULSORY COMPETENCY MODULE: INTRODUCTION TO REGULATORY REQUIREMENTS FOR BIOMEDICAL TECHNICAL PERSONNEL
Date (Day)	17 March 2021 (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)	18 March 2021 (Thursday)
Time	10:00 AM –  11:30 AM (EXAMINATION)
10:00am – 11:30pm	Online Examination

 

REGISTRATION AND TRAINING FEE

Training fee for per participant: RM 750

The closing date for registration is on 10^th March 2021.

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.