July 13, 2018
The number of registered medical devices which become obsolete and get discontinued and become orphaned are increasing in Malaysia with no policy in place to control them to meet requirements in accordance with the purposes of this Act.
Thus, a new policy has been officialy issued to manage these obsolete, discontinued & orphaned medical devices in healthcare institutions around the country, in the form of Circular Letter No.2 Year 2018, on 22 May 2018. This CL which is, effective from the issuance date, has set the implementation and enforcement control of orphaned, obsolete and discontinued medical device in hospital or healthcare facilities institution as follows:
a) Healthcare facilities institution which have orphaned medical devices shall identify and provide the notification/ listing to the Medical Device Authority.
b) The risk of using orphaned, obsolete and discontinue medical device prior to the effective date of Act 737 is under the liability of users and healthcare facilities institution.
c) Any medical device placed in the market after the effective date of Act 737 and continues to be marketed is required to be registered under the Act.
Circular Letter No 2 Year 2018: Control of Orphaned, Obsolete and Discontinued Medical Device in Hospital or Healthcare Facilities Institution