Malaysia FDA Registration

Malaysia offers one of Southeast Asia’s most robust and dynamic markets for foreign medical device manufacturers. To obtain market authorization in Malaysia, you must first register your product with the Malaysian Medical Device Authority (MDA). Registration with the MDA is done electronically through the web-based Medical Device Centralised Online Application System ,and can only be done by the local Authorized Representative.

The Malaysian medical device registration process

If your device is approved in one of the recognized reference markets (US, European Union, Australia, Japan or Canada), you can leverage this approval and follow a simplified registration process as outlined below. Download our registration process chart on Malaysia to better understand this process. Here are the basic steps:
USFDA Corp can help register your medical device or IVD in Malaysia

With an office in Kuala Lumpur, USFDA Corp can assist with your registration and interact with the Medical Device Authority on your behalf. Here’s how we can help: Other Countries FDA Services USFDA


  1. USFDA Corp Registration. It's Free
  2. Fill the application Form
  3. USFDA Corp Account Manager contacts you
  4. All relevant documents are collected from your team required by FDA
  5. USFDA Corp services & FDA charges financial quote is provided
  6. On financial quote approval your FDA Registration is completed as per the schedule provided by USFDA Corp
  7. 24x7 x 365 Free Support by USFDA Corp

Have a question or need a custom quote?

Our consultants are waiting for your call for your company FDA registration requirements.
+1 (909) 280 0838