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TRAINING BY THE AUTHORITY: - MEDICAL GAS SYSTEM TRAINING : INTRODUCTION TO REGULATORY REQUIREMENTS

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TRAINING BY THE AUTHORITY: -
MEDICAL GAS SYSTEM TRAINING : INTRODUCTION TO REGULATORY REQUIREMENTS

 

INTRODUCTION

This regulatory module is designed to provide participants with the knowledge of medical device regulatory requirements in Malaysia. This traning specifies the needs for industries especially those in medical gas system field on how to submit the registration application.

 

OBJECTIVES

To provide an overview of the Medical Devices Act 737, and Medical Device Regulation 2012. To provide the medical device regulatory requirements for submitting registration’s application of medical gas system

 

TARGET AUDIENCE

Industries involve in manufacturing, distributing and installing medical gas system in the Malaysia market.

 

TENTATIVE

TRAINING BY THE AUTHORITY: - MEDICAL GAS SYSTEM

Date (Day)

 

26 June 2020 (Friday)

Time

 

8.00 AM – 5.00 PM

Venue

 

ONLINE MEETING PLATFORM

      TENTATIVE                  

8.15 am   -   8.30 am

Registration

8.30 am   –   9.30 am

Medical Device Act 2012, Act 737 & Medical Device Regulation 2012

9.30 am   –   9.45 am

Opening Remark by Chief Executive

9.45 am   –  10.45 am

Licensing Establishment & GDPMD

10.45 am – 11.30 am

Overview Of GD-Medical Gas System

11.30 am – 12.15 pm

Medical Device Classification

2.45 pm   –  3.15 pm

Medical Device Registration Requirement

3.15 pm   –  4.00 pm

CSDT & EPSP

4.15 pm   –  4.45 pm

Post Market Regulation

4.45 pm   –  5.00 pm

QnA

 

End

 

The closing date for registration is on 24 June 2020.

Should you have any enquiries, please do not hesitate to email us or contact Mr Luqman at 603 8230 0212 (luqmanhafifi@mda.gov.my) / Mr Talha at 603 8230 0383 (muhammadtalha@mda.gov.my)

 

REGISTRATION AND TRAINING FEE

Training fee for per participant: RM 700

Kindly complete the provided Registration Form and submit to trainingpackage@mda.gov.my. Upon acceptance of the Registration Form, An invoice (for payment purpose) together with details of payment method will be issued accordingly. The closing date for registration is on 24th June 2020.

To register, please click HERE

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.

Print

  Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb@mda.gov.my

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  • Last Modified: 08 October 2020.
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