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ONLINE TRAINING BY THE AUTHORITY MEDICAL GAS SYSTEM REGULATORY REQUIREMENTS

 

 

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ONLINE TRAINING BY THE AUTHORITY

MEDICAL GAS SYSTEM REGULATORY REQUIREMENTS

 

 

Date                : 13th December 2021

Time               : 9.00 am – 5.00 pm

Venue             : Virtual platform (Zoom Meeting)

 

INTRODUCTION

Medical gas system (MGS) is an essential part of any healthcare facility, a failure of which can contribute to the morbidity and/or death of the patient. MGS has inherent multiple hazards and risks to the patients, operators and person at the healthcare facility that may be associated with these devices.

It is essential that all elements such as the design, manufacturing and installation of MGS intended to be placed in Malaysian market shall meet the standards of safety, quality and performance.

Section 5(1) of Medical Device Act 2012 (Act 737) requires that a medical device is registered under the Act before it can be imported, exported or placed in the market.

Therefore, this training aims to provide participants with the knowledge of medical gas system regulatory requirements for registration in Malaysia.

OBJECTIVE

  • To provide overview of Medical Device Act 2012 and its subsidiary legislations
  • To provide understanding about medical gas system regulatory requirements to industries and stakeholders.
  • To assist the industry and healthcare professionals in order to comply with the Medical Device Act (Act 737) and the regulations under it.

 

TARGET AUDIENCE

  • Medical Gas System Establishment (Manufacturers, Authorized Representative, Distributor, Importer)
  • Medical Gas System Technical Personnel
  • Medical Gas System Service Provider
  • Regulatory affairs personnel
  • Conformity Assessment Bodies (CABs);
  • Other Medical Device Industry players
  • Anyone involved with medical gas system
  • Healthcare professionals
  • Interested individuals

 

PROGRAMME OUTLINE

TIME

TOPIC

SPEAKER

 

08.30 AM

Registration

08.50 AM

Briefing

09:00 AM – 10.15 AM

Medical Device Act 2012 and Subsidiary Legislations

En. Luqman Hafifi bin Che Yussof

10:15 AM – 11.30 AM

Establishment Licensing

-       QMS requirements

-       Application / Amendment / Renewal

-       Change ownership

Pn. Norfazlin binti Rasidi

11.30 AM 1.00 PM

Medical Device Registration

-       Grouping

-       Risk Classification

-       EPSP

-       CSDT

-       Conformity Assessment

Pn. Nor Hasyimah binti Abdul Razak

1.00 PM – 2.00 PM

Lunch Break

2.00 PM – 3.00 PM

Post-market duties and obligations

En. Muhammad Ikhwan Hafiz Bin Zainuddin

3.00 PM – 4.00 PM

Overview of MS2675:1 2017 Medical Gas System Code of Practice

Ir. Al-Khairi Mohd Daud

4.00 PM – 5.00 PM

Medical Gas System Risk and Safety Management

Ir. Al-Khairi Mohd Daud

End of Training

 

REGISTRATION AND TRAINING FEE

  • The closing date for registration is on 6th DECEMBER 2021.
  • Training fee per participant: RM 700.00
  • 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.
  • Limited to 150 participants.
  • Upon payment confirmation, MDA will provide a link to join the training program.
  • Once paid, registration fee is non-refundable.

CONTACT

For enquiries, please contact trainingpackage@mda.gov.my or 03-8230 0240 / 0355 / 0211

 

Updated: 18 November 2021

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: 30 November 2021.
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