To apply for Class A medical device registration in Malaysia, you need to submit your application through the Medical Device Authority (MDA), specifically using the Medical Device Centralized Online Application System (MeDC@St). This is Malaysia's official online portal for medical device registration.

Steps for Applying through MeDC@St:

1. Create an Account:

   • Register an account on the MeDC@St portal: https://medcast.mda.gov.my.
   • Both local and foreign manufacturers can create accounts, but foreign manufacturers must appoint a licensed Authorized Representative (AR) in Malaysia to submit the application on their behalf.

2. Complete the Application:

   • Upload all necessary documentation, including the ISO 13485 certification, technical file, and Declaration of Conformity.
   • Fill in the device information, and provide labeling and intended use details as required by the MDA.

3. Pay the Registration Fee:

   • Submit the required fee online through the portal.

4. Await MDA Review and Approval:

   • After submission, the MDA will review the application. Once approved, you will receive a registration certificate through the MeDC@St system.

By following these steps on the MeDC@St portal, you can complete the application process for Class A medical devices in Malaysia. For questions or additional support, the MDA office in Malaysia can also provide guidance:

• MDA Contact Information:
  • Website: https://www.mda.gov.my
  • Address: Ministry of Health Malaysia, Medical Device Authority (MDA), Level 5, Menara Prisma, No. 26, Jalan Persiaran Perdana, Precinct 3, 62675 Putrajaya, Malaysia.
  • Phone: +603-8892 2400
  • Email: mdb@mda.gov.my

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn