Malaysia regulates devices under the Medical Device Act 2012 which was made effective on July 1, 2013 and provided a 2 year grace period for compliance.
Recent guidance has provided for registration exemption for Class A devices (non measuring, non sterile) and a fast track provisional registration process for all other devices that have refernce country approval that effectively extends the grace period for full registration for another 5 years.
According to the Act, medical devices require registration with the Medical Device Authority (MDA) of the Ministry of Health Malaysia (MoHM) before being imported and placed on the market. Applications must be submitted via an on-line MEDCAST system by a licensed, local entity that also acts as license holder, or Malaysia Authorized Representative.
The application requires a Certificate of Conformity from a local, authorized conformity assessment body (CAB). Under the fast track system, devices with reference country approval have up to 5 years to submit the locally issued Certificate of Conformity and will be issued provision registration in the meantime.
The cost of registration application and assessment varies by device classification as below:
Official application processing times are not yet available.
Quality systems confirmity assessment must be documented with ISO 13485 or an audit report from the FDA (e.g., Establishment Inspection Report) or Japanese PMDA.
Contact Asia Actual for assistance to confirm the cost and time lines that apply to your medical devices. Asia Actual also has experienced, top level consultants in Malaysia to manage the application process.