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IMPORT AND/OR SUPPLY OF UNREGISTERED MEDICAL DEVICES FOR THE PURPOSE OF DEMONSTRATION FOR MARKETING PDF Print E-mail

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IMPORT AND/OR SUPPLY OF UNREGISTERED MEDICAL DEVICES FOR THE PURPOSE OF DEMONSTRATION FOR MARKETING OR EDUCATION

This Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their quest to comply with the Medical Device Act (Act 737) and the regulations under it.

This Guidance Document shall be read in conjunction with the current laws and regulations used in Malaysia, which include but not limited to the following-

a) Medical Device Act 2012 (Act 737); and

b) Medical Device Regulations 2012.

In this Guidance Document, the following verbal forms are used:

— “shall” indicates a requirement;

— “should” indicates a recommendation;

— “may” indicates a permission; and

— “can” indicates a possibility or a capability.

Irrespective of the requirements of this Guidance Document, MDA has the right to request for information or material, or define conditions not specifically described in this document that is deemed necessary for the purpose of regulatory control.

MDA has put much effort to ensure the accuracy and completeness of this guidance document. In the incident of any contradiction between the contents of this document and any written law, the latter should take precedence.

MDA reserves the right to amend any part of the guidance document from time to time.

This draft document is open for comment and feedback.

Please CLICK HERE  to download the guidance document.

Please CLICK HERE to download the form to give comment and feedback.

Please submit your feedback form to This e-mail address is being protected from spam bots, you need JavaScript enabled to view it before 16th November 2017

Last Updated ( Wednesday, 01 November 2017 )
 
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