COMPULSORY COMPETENCY MODULE: INTRODUCTION TO REGULATORY REQUIREMENTS FOR BIOMEDICAL TECHNICAL PERSONNEL (BTP)
ONLINE TRAINING BY THE AUTHORITY
COMPULSORY COMPETENCY MODULE:
INTRODUCTION TO REGULATORY REQUIREMENTS FOR BIOMEDICAL TECHNICAL PERSONNEL (BTP)
| Date: | 1 December 2021 (Wednesday) | 9.00 AM – 5.00 PM (TRAINING) |
| Date: | 2 December 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 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
PROGRAMME OUTLINE
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ONLINE TRAINING BY THE AUTHORITY: - COMPULSORY COMPETENCY MODULE: INTRODUCTION TO REGULATORY REQUIREMENTS FOR BIOMEDICAL TECHNICAL PERSONNEL |
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Date (Day) |
1 December 2021 (Wednesday) |
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Time |
9:00 AM – 5:00 PM (ONLINE TRAINING) |
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DAY 1 |
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09:00am – 09:10am |
Briefing |
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09:10am - 10:10am |
Medical Device Act, 737 |
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10:10am – 11:10am |
Medical Device Regulation 2012 |
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11:15am – 12:15pm |
Licensing of Establishment |
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12:15pm – 13:00pm |
Medical Device Registration Requirement |
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13:00pm – 14:00pm |
Lunch Break |
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14:00pm – 14:45pm |
Atomic Energy Licensing Act 1984 (Act 304) |
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14:45pm – 15:30pm |
Medical Device Disposal MS 2650:2015 |
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15:30pm – 16:15pm |
Overview of Medical Device Regulatory Requirement in Healthcare Institution |
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16:15pm – 17:00pm |
Post Market Regulation |
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DAY 2 |
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Date (Day) |
2 December 2021 (Thursday) |
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Time |
10:00 AM – 11:30 AM (EXAMINATION) |
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10:00am – 11:30pm |
Online Examination |
REGISTRATION AND TRAINING FEE
Training fee for per participant: RM 750
The closing date for registration is on 12th NOVEMBER 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.
