Overview of Malaysian medical device regulations
The Medical Device Authority (MDA) regulates medical and in vitro diagnostic (IVD) devices in Malaysia. All devices require pre-market authorization, and manufacturers entering the Malaysian market will be able to leverage their existing approvals in recognized reference markets for an abridged review process.
The Malaysian MDA medical device regulation process
The chart illustrates the MDA approval process per device classification in Malaysia and is available for download in the Regulatory Affairs Management Suite (RAMS). Only a simplified overview of the main steps for registration is provided here.
Determine the classification of your device according to the MDA’s classification rules.
Appoint a local Authorized Representative (AR) to manage your medical device registration and interact with the MDA on your behalf.
Prepare an ASEAN common submission dossier template (CSDT) and engage an accredited conformity assessment body (CAB) to review your documentation. Devices in the lowest risk class are exempt from CAB review.
The CAB reviews your documentation and, upon positive evaluation, issues a conformity assessment report and certificate.
Compile all required documentation, forms and the CAB certificate (if applicable) for submission to the MDA.
Your AR submits the application electronically via the MDA’s online system and pays the application fee.
The MDA reviews the application and may request additional information.
Upon approval, a registration fee is due. Once paid, the MDA issues the registration certificate with the assigned registration number.
Log in to RAMS to view the chart
This is a condensed version of the steps outlined in the chart and only addresses the primary registration pathway in the market. You can obtain a detailed process chart and market reports for Malaysia when you create your complementary Regulatory Affairs Management Suite (RAMS) account. Get your first chart for free when you create a RAMS account.