8th November, 2017
A new Circular Letter was released by Medical Device Authority (MDA) on October 2, 2017, in which MDA recognizes Institute of Medical Research (IMR) Malaysia as a credible source to provide clinical evaluation data for conformity assessment purposes conducted by a Conformity Assessment Bodies (CAB) in Malaysia. This Circular Letter comes into effect starting October 2, 2017.
Currently, Full Conformity Assessment service is not widely provided by CABs in Malaysia, especially on medical devices that detect infectious diseases (e.g. Malaria kits, Dengue detection kits, etc.). Local technical personnel conducting assessments on IVD medical devices are also inadequate and the assessments have to be sent abroad. Thus, to solve this issue, MDA has now started to recognize the local establishment, IMR, as one of the credible sources in Malaysia to provide clinical evaluation data for conformity assessment purposes (Full Evaluation route), conducted by a CAB in Malaysia.
When a medical device doesn’t have any approval from one of the GHTF countries, manufacturers can either start with applying for a CE marking with an EU based Notified Body and let the Malaysian CAB conduct just Verification Assessment on the device later or opt to have the device undergo Full Conformity Assessment route, from the start, with a CAB in Malaysia. For technical documents' assessment and to provide clinical evaluation data, these CABs can now collaborate with IMR, since it is cheaper and more time saving than sending it abroad for the assessments. This recognition will prove to be quite cost-saving henceforth, for CABs and manufacturers to opt for Full Conformity Assessments locally.
Circular Letter of the Medical Device Authority (No. 4 of Year 2017): Recognition of Institute for Medical Research (IMR) To Provide the Report or Data of Clinical Evidence or Performance Evaluation for the Purpose of Conformity Assessment by Conformity Assessment Body