Malaysia: Control of Orphaned, Obsolete and Discontinued Medical Devices in Hospitals, Healthcare Institutions or Any Related Facilities

On 28th July 2019, the Medical Device Authority (MDA) in Malaysia released a revision of the circular letter, dated 22nd May 2018, on the control of orphaned, obsolete and discontinued medical devices in hospitals, healthcare institutions or any related facilities. According to the circular letter, an orphaned, obsolete and discontinued medical device is exempt from medical device registration and establishment license requirements; however, healthcare facilities that are in possession of orphaned, obsolete or discontinued medical devices must provide a notification/listing to the Medical Device Authority.
On 28th July 2019, the Medical Device Authority (MDA) in Malaysia released a revision of the circular letter, dated 22nd May 2018, on the control of orphaned, obsolete and discontinued medical device in hospitals, healthcare institutions or any related facilities.
An orphaned medical device is an existing medical device in a hospital, healthcare institution or any related facility that is not registered under Act 737 as it no longer has the manufacturer or authorized representative to register the medical device. Obsolete medical devices are outdated medical devices that are no longer used due to design changes or the evolution of new technologies etc. Discontinued medical devices are medical devices that are no longer distributed in the market or are no longer being produced.
According to the circular letter,
a) An orphaned, obsolete and discontinued medical device is exempt from medical device registration and establishment license requirements
b) Establishments or healthcare institutions in possession of orphaned, obsolete or discontinued medical devices must provide a notification/listing to the Medical Device Authority
c) The risk of using orphaned, obsolete and discontinued medical devices the responsibility of the establishment, users and healthcare institution
d) Establishments shall be responsible for post-market issues associated with any obsolete or discontinued medical device for the projected useful life of the medical device as determined by the manufacturer
e) Compliance is required with notification requirements as specified by the Authority
This circular letter shall be used as part of requirements under Act 737 and shall be effective from the date it is issued. The revised circular letter can be referred to here and the original circular letter released in 2018 can be referred to here.