Home About Qualtech NEWS MALAYSIA: New Revision Introduced to Circular Letter No.2 Y 2018Control Of Orphaned, Obsolete And Discontinued Medical Device In Hospital Or Healthcare Facilities Institution - August, 2019
MALAYSIA: New Revision Introduced to Circular Letter No.2 Y 2018Control Of Orphaned, Obsolete And Discontinued Medical Device In Hospital Or Healthcare Facilities Institution - August, 2019

August 12, 2019

MDA has recently introduced revision of Circular Letter No.2 Year 2018: Control of Orphaned, Obsolete and Discontinued Medical Device in Hospital or Healthcare Facilities Institution. In this revision, MDA has emphasized that whichever establishment that still keeps around any orphaned, obsolete or discontinued medical device shall be solely responsible for all the post-market issues associated with these devices. This in accordance with the projected useful life of the medical device as determined by the manufacturer.

 

It was earlier established that orphaned, obsolete and discontinued medical devices do not have local representation anymore and due to that, MDA has found the need to re-instate the above statement in the CL revision. Furthermore, the establishments may have to be in compliance with any notification requirements with certain charges as may be specified by the Authority, from time to time.

This CL is effective from the date it is issued, i.e. 22 July 2019.

 

 

Reference:
Circular Letter No.2 Y 2018 (R.1) Control Of Orphaned, Obsolete And Discontinued Medical Device In Hospital Or Healthcare Facilities Institution

 


Tags:

Orphaned medical devices; Obsolete medical devices; Discontinued medical devices 

 

 

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Home About Qualtech NEWS MALAYSIA: New Revision Introduced to Circular Letter No.2 Y 2018Control Of Orphaned, Obsolete And Discontinued Medical Device In Hospital Or Healthcare Facilities Institution - August, 2019