April 9th, 2018
Following a list new regulations and requirements released in March 2018, MDA has issued a new guidance document which specifies requirement on notification for importation and/or supply of medical devices intended solely for the purpose of demonstration for marketing or for the purpose of education.
According to this guidance document, medical devices for the purpose of demonstration for marketing and for the purpose of education has been exempted from registration with the Authority and are eligible for notification of exemption. An applicant who wishes to import and/or supply of a medical device for the purpose of demonstration for marketing or education shall notify the Authority by following the steps as summarized in Annex A of this Guidance Document.
First, the manufacturer has to identify the requirements to obtain an exemption, which are categorised into two, in this documents and confirm if the product is a medical device.
Then, they can proceed to submit necessary documents for the Notification of Exemption from MDA. There is the new application and renewal application procedure and relevant information provided, regarding the submission.
This guidance documents also lists out the duties and responsibilities which have to be adhered to by the applicant while handling the unregistered medical device during the period of the demonstration for marketing or for the purpose of education and after the demonstration activity is over.
Guidance Document: Import and/or Supply of Unregistered Medical Devices for the Purpose of Demonstration for Marketing or Education
- MALAYSIA: New Guidance Document Issued on Import and/or Supply of Unregistered Medical Devices For The Purpose Of Demonstration for Marketing or Education – April 2018