April 9th, 2018
The Medical Device Authority (MDA) has issued a new Circular Letter on March 5th 2018 bearing new requirements for the licensing and medical device registration for Original Equipment Manufacturer (OEM) in Malaysia. This circular letter identifies who construes as an OEM and the reason why OEMs are not regulated under the Medical Devices Act 2012 (Act 737) till far.
Thus, this circular letter serves as a predecessor for an appropriate policy being developed to facilitate OEMs for obtain License and registering products in order to apply for CFS to market their products globally.
According to the regulation, it has been set that a local manufacturer who also perform activities as an OEM must
i) Be licensed as a registered Manufacturer with MDA
ii) Register the medical devices under its own brand, with them being the legal manufacturer
iii) Declare that the listed brand is the same as the registered medical device brand (in terms of manufacturing processes, specifications and etc.)
As for OEM who don’t own the medical device brands in question, they must
i) Be licensed as Authorised Representative (AR)
ii) Apply for product registration using a brand name or medical device name but this application is exempted from undergoing a conformity assessment by a Conformity Assessment Body (CAB), according to MDA Circular Letter No. 1 of Year 2017 whereby export only medical devices comply under this exemptions.
This regulation has been implemented since March 5th 2018 and it can be consulted at this link.
Circular Letter of MDA No.1 Year 2018: Licensing and Medical Device Registration for Original Equipment Manufacturer (OEM)