MEDICAL DEVICE AUTHORITY INDUSTRY DIALOGUE 2022

Day/Date: Thursday, 6th October 2022

Venue: Conference Hall 3, Level 3, West Wing Kuala Lumpur Convention Centre (KLCC), Malaysia

 

 

MDA Industry Dialogue 2022

 

 

Following the gazettement of Medical Device Authority Act (Act 738), MDA was formed as a statutory body that is responsible for the implementation and enforcement of Act 737. Implementation of regulatory control under the medical device law is of great benefit to the Malaysian public as all medical devices to be placed in our market must demonstrate compliance with safety and performance requirements as stipulated under Medical Device Act 2012 (Act 737). The regulatory control provides an appropriate framework for ensuring public health and safety by ensuring access to safe and effective medical devices while preventing sub-standard, unsafe and ineffective devices from reaching the market. 

MDA and Invest Selangor (ISB) agreed for collaboration to encourage, strengthen, promote, develop and facilitate cooperation in the field of medical devices and related technology and towards a successful organization of the Selangor International Expo (MEDIC), and the MoU signing took place on 2 September 2022.

This MDA Industry Dialogue 2022 is held in conjunction with the Selangor International Expo (SIE MEDIC) 2022. It will serve as a strategic platform for medical device industry to convey any issues/problems/suggestions/opinions to MDA, relating to implementation of medical device regulatory system in Malaysia.

 

Venue

Conference Hall 3, Level 3, West Wing Kuala Lumpur Convention Centre (KLCC) Malaysia

Who Should Attend?

Stakeholders that involved in the medical device industry who are comprised of the following are welcomed to join the MDA Industry Dialogue 2022:

  • Manufacturers
  • Authorized Representative
  • Importers
  • Distributors
  • Conformity Assessment Body (CAB)
  • Healthcare Facility, Medical Device User (professional/home-use)
  • Parties involved in medical supply chain (Tendering Agent, Freight Forwarder, etc.)

Registration

  • This event has reached maximum capacity and registration NOW CLOSED
  • Only registered participants are allowed to attend the event


Regulatory Feedback Form

  • Kindly provide issues/problems/suggestions/opinions that are to be discussed during the MDA Industry Dialogue 2022 by filling out the form via the following link and send to email.
  • Closing date for submitting the Regulatory Feedback Form is on 26 September 2022 (Monday)

MDA Industry Dialogue 2022 managed by :

Industry Facilitation Branch

Policy, International Affairs & Industry Facilitation Division (DASAR), MDA

Email : [email protected]

Hotline : 03-82300392 (Mr Shahrezza); 03-82300395 (Mr Fezri); 03-82300253 (Madam Aisyah)

Tentative

PROGRAMME

8:30 – 9:30 am

Registration & Refreshment

9:45 am

Welcome Address

Mr Ahmad Shariff Hambali

Chief Executive, Medical Device Authority

10:00 am        

Medical Device Regulatory Update

Mdm. Salbiah Yaakop,

Director of Policy, International Affair and Industry Facilitation Division (DASAR)

 

11:30 am        

Requirements for Labelling of Medical Devices

Mdm. Norhafizah Mohd Salleh,

Head of Policy and International Affairs Branch, DASAR

1:00 pm

Lunch Break (Lunch not provided)

2.00 pm

MDA Industry Dialogue 2022

Moderator : Mr. Ahmad Farhan Mohd Yunus,

Head of Corporate Communication Unit

Panelists:

·         Mr Ahmad Shariff Hambali, MDA  Chief Executive

·         Mdm Salbiah Yaakop, Director of DASAR

·         Mdm Aidahwaty M.Olaybal, Director of Pre-Market Control Division

·         Mdm Idamazura Idris @ Harun, Director of Post-Market & Enforcement Division

·         Mdm Norlela Hatta @ Antah, Head of Industry Facilitation Branch, DASAR

4:00 pm

Discussion and Q & A

4:30 pm

End of  MDA Industry Dialogue 2022 & Tea Session

 

Updated: 23th September 2022