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February 14, 2020
Earlier in January 2020, MDA had released a revised Circular Letter No. 2 Year 2018, which is pertaining to the control of orphaned, obsolete and discontinued medical device healthcare and related facilities. There have been some revisions introduced to the definition of types of medical devices covered in this circular letter.
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CL No. 2 Year 2018 (R.1)
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CL No. 2 Year 2018 (R.2)
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Orphaned medical device means an existing medical device in a hospital, healthcare facilities institution or any related facilities that is not registered under this Act as it no longer has the manufacturer or authorized representative to register the medical device.
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Orphaned medical device means an existing medical device in a hospital, healthcare facilities or any related facilities where the manufacturer or authorized representative has ceased operation.
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Obsolete medical device means outdated medical device, or no longer used due to design changes, evolution of new technologies and etc.
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Obsolete medical device means an existing medical device in a hospital, healthcare facilities, or anu related facilities which is outdated, or no longer being manufactured due to design changes, evolution or new technologies.
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Discontinued medical device means medical device that is no longer distributed in the market or no longer being produced.
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Discontinued medical device means an existing medical device in a hospital, healthcare facilities, or any related facilities that is no longer in the distribution.
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Apart from these changes, there have been no other revisions introduced. All stakeholders are required to take note of these changes.
References:
Circular Letter No. 2 Year 2018 (R.2): Control of Orphaned, Obsolete and Discontinued Medical Device Healthcare and Related Facilities
Tags:
Malaysia; MDA; Orphaned; Obsolete; Discontinued
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