Last year, MDA had issued a Circular Letter on the control of orphaned, obsolete and discontinued medical device in healthcare institutions. They specified definition of orphaned, obsolete and discontinued medical devices. On top of that, it has been decided that these medical devices are exempted from registrations and their risks would fall upon the establishment, users and healthcare facilities institution.
Now, all orphaned, obsolete and discontinued medical device still in active use must be notified with MDA, so that both the device and user safety can be regulated. MDA has come up with a detailed guidance document to assist these institutions and end users while working with these group of medical devices.
- Firstly, criteria for medical devices which can be categorised as obsolete ad discontinued have been drawn.
- Secondly, MDA has specified who can be appointed as person responsible for these group pf medical devices, as they pose high safety and performance risks
- Next up, responsibilities for establishments which continue to utilise these group of medical devices have been pin-pointed.
Establishment which still actively use these orphaned, obsolete and discontinued medical devices shall submit the afore-mentioned Notification by email to MDA. Each notification submitted shall be for one medical device / medical device grouping only, with a fee of RM 300 per application. There are a number of conditions to be met for a successful notification, which can be consulted in the guidance document.