Malaysia Issues Guidelines for Medical Device Registration

Malaysia’s Medical Device Authority (MDA) has released final guidelines for the registration of medical devices under the country’s 2012 Medical Device Act. According to the guidelines, all registrations should take place through MeDC@St, the MDA’s Medical Device Centralized Online Application System.

An authorized representative or the manufacturer of a medical device sold or manufactured in Malaysia must use MeDC@St to submit the following documentation:

  • General information (including the type and class of the medical device)
  • Information of manufacturer (including manufacturer’s address and website)
  • Grouping of medical device (including outsourced components)
  • Common Submission Dossier Template (CSDT)
  • Supporting documents for CSDT
  • Post-market vigilance history (including adverse event reports)
  • Declaration of Conformity
  • Attestation for medical device registration application

Conformity assessments must be conducted by an approved Conformity Assessment Body (CAB). So far, the MDA has authorized three of the ten companies that have applied for CAB status: BSI Services Malaysia, SGS (Malaysia) and SIRIM QAS International.