February 14, 2020

MDA has issued a new revision to the Guidance Document MDAGD0018 Import And Or Supply of Unregistered Medical Devices for The Purpose of Demonstration for Marketing or Education. They have introduced some changes to the description of category of exemptions allowed, as below:

 

MDAGD0018 (1st Edition)

MDAGD0018 (2nd Edition)

Category of exemption

Description

Medical device for the purpose of demonstration for marketing

The importation and/or supplying of medical devices for an activity purely intend for :

1. Direct presentation or explanation to medical officer;

2. Exhibits or display in trade shows, fairs, and exhibitions.

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.

Medical device for the purpose of education.

The importation and/or supplying of medical devices for an activity purely intend for teaching, training or educating people.

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.

  • Minimum notification submission period has been reduced from 30 days to 14 days, prior to importation or supplying the medical device.
  • All applications shall be made through the [email protected], making previously used email address ( [email protected]) obsolete in this case.
  • For importation of unregistered medical devices for purpose of education, applicants shall also make sure there is no similar medical device available in Malaysia market. They shall state reason on why it has to be the specific medical device and list make comparison with medical devices already available in the Malaysian market.
  • Distribution of free samples is prohibited.
  • The name of notice for post handling of medical devices for the purpose of demonstration has been changed from “Dispose or Exported Out of Malaysia” Notice Form to “Post handling” Notice Form, which has to be submitted via [email protected]

All stakeholders are advised to take of these changes while making an application for the Notification of Medical Device for Demonstration purposes, to ensure a smooth process.

References:
MDAGD0018: Guidance Document on Import And Or Supply of Unregistered Medical Devices for The Purpose of Demonstration for Marketing or Education 2nd Edition


Tags:

Malaysia; MDA; Orphaned; Obsolete; Discontinued

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