September 17, 2018
In Malaysia, medical devices procurement by local healthcare institutions are heavily controlled in order to make sure the supplied medical devices are safe and efficient. For starters, there are many procurement methods, depending on the product’s market value.
However, for all procurement procedures, MDA has set strict requirements for the healthcare institution’s procurement department to request for certain administrative documents from the relevant establishments. For the non-aware, relevant establishment here also refers to tendering agents who also conduct manufacturing, importation and distribution activities of any medical devices in the market.
In the original version of Circular Letter No.2 Year 2016, MDA has established requirements for healthcare institutes intending to make direct medical device procurements to request for the following documents from the relevant establishments:
a) Valid copy of Establishment License (as in Attachment A of the relevant C.L)
b) Valid copy of the medical device’s MDA registration certificate (as in Attachment B of the relevant C.L) or Letter of Acknowledgement Receipt of Application for Medical Device Registration under Medical Device Act 2012 (Act 737) (as in Attachment C of the relevant C.L)
Furthermore, for any healthcare institutions which conduct medical device procurement activities through a tendering agent (including procurement via direct business, not limited to quotation/tender issuance only), the healthcare institution has to request for the following documents from the relevant tendering agent:
a) Valid copy of Establishment License (as in Attachment A of the relevant C.L)
b) Valid copy of the medical device’s MDA registration certificate (as in Attachment B of the relevant C.L) or Letter of Acknowledgement Receipt of Application for Medical Device Registration under Medical Device Act 2012 (Act 737) (as in Attachment C of the relevant C.L)
c) Letter of Appointment as Tendering Agent from the relevant establishment.
In the recently issued revised version of Circular Letter No.2 Year 2016, there has been a slight change in the documentary requirement set by MDA to be requested from the relevant establishments involved in the procurement procedure. For direct procurement, the following change is to be noted:
a) Valid copy of Establishment License (as in Attachment A of the relevant C.L)
b) Valid copy of the medical device’s MDA registration certificate (as in Attachment B of the relevant C.L) or Notification of Low Risk Medical Device (as in Attachment C of the relevant C.L)
For procurement process involving a tendering agent, the following change in documentary requirement is to be noted:
a) Valid copy of Establishment License (as in Attachment A of the relevant C.L)
b) Valid copy of the medical device’s MDA registration certificate (as in Attachment B of the relevant C.L) or Notification of Low Risk Medical Device (as in Attachment C of the relevant C.L)
c) Letter of Appointment as Tendering Agent from the relevant establishment.
Reference:
Circular Letter No.2 Year 2016 (Rev.1) –Medical Devices Procurement for Healthcare Institutions