The Malaysian Medical Device Authority (MDA) has revoked Circular Letter No. 1/2014 that contains two components, namely establishments acting as authorized representatives (AR) and establishments carrying out different activities, in September 2021. This is in accordance with MDA Meeting No. 2/2021’s outcome and has a few implications for those looking to register medical devices in Malaysia.
The first component is regarding the establishments acting as authorized representatives. Previously, each imported medical device had to be handled by one authorized representative only. MDA has decided to no longer limit the number of authorized representatives that are able to import and place medical devices on the Malaysian market and has given the green light for multiple authorized representatives to register a medical device. This is effective from 17 June 2021.
As for the second component, which is about establishments carrying out different activities, there is a major update after the rescindment of the circular. MDA has implemented the rule that one license can only be used for one activity, whereas previously, one license can be used as a combination for all the different activities.
More details can be found in:
- “PEMBATALAN SURAT PEKELILING PIHAK BERKUASA PERANTI PERUBATAN (PBPP) BIL 1/2014, September 2021” (in Malay): https://www.mda.gov.my/announcement/663-pembatalan-surat-pekeliling-pihak-berkuasa-peranti-perubatan-pbpp-bil-1-2015.html