Introduction:

This exemption is eligible for the medical device that intend to used for the purpose of;

1. Demonstration for marketing

a) An activity to introduce a medical device to the vast market e.g. in trade fairs or exhibition or scientific or technical gatherings which is not to be used on human for a purpose to gather marketing information in a specific period of time before the device being registered. In the period of marketing demonstration, all marketing activities such as promoting and information distribution such as posters, notices, brochures, pamphlets, banners, buntings, photographs, video clips with limited information specifically on device’s specification and features are allowed.

b) For IVD device, it also includes reliability or quality testing activity(ies), where the result obtained are solely used for the purpose of enhancing trust and confidence towards the device(s). In this instance, the result cannot be used to support or reject patient’s diagnosis / treatment.

 

2. Educational purposed;

An activity that is purely for teaching, training or educating people without having any kind of intention related to promoting or marketing and not to be used on human or for the purpose of diagnosis/treatment.

Note:

  1. The applicant is responsible to confirm that the products are medical devices. Such products which do not meet the medical device definition are not eligible for this medical device notification.
  2. The applicants who require confirmation if their product is a medical device may refer to guidance document MDA/GD/0006 Definition of Medical Device.

 

ANNOUNCEMENT:

GUIDANCE DOCUMENT:

Import And/or Supply of Unregistered Medical Devices for The Purpose of Demonstration for Marketing or Education

 

HOW TO APPLY:

  1. Create  MeDC@St> Account for Notification 
  2. Submit Notification through   MeDC@St system

 

ADMINISTRATIVE CHARGE: RM300 per application

 

PROCESS FLOW:

  1. Import for  The Purpose of Demonstration of Marketing 
  2. Import for  The Purpose of Education 

 

For any inquiries please email to demo.edu@mda.gov.my

Officer In charge: Sharifah Nur Ilani (Pn Ilani) +603 - 8230 0363

 

 

Prepared by:  International & Industry Relations Division 

Uploaded by: Corporate Communication Division

Date of upload: 24th November 2025