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Medical Devices Registration in Malaysia

  • Medical Devices Registration in Malaysia

  • The domestic Medical Devices Market in Malaysia is estimated US$2 Billion growing at CAGR of 7.5%

  • Malaysian Manufacturers supply 60% of world’s medical gloves and 80% of catheters

  • Malaysia currently imports 95% of its medical devices

  • Malaysia has moderately higher per capita income and GDP, therefore, there is a growing need for robust healthcare solutions.

Regulatory Authorities in Malaysia for Medical Devices

Medical Devices in Malaysia re regulated by Malaysian Medical Device Authority (MDA). The Medical Devices need to be registered in Malaysia before they can be sold. Since July 1, 2016, MDA has mandated foreign manufacturers to register their medical devices under the Medical Device Act. It is also mandatory for manufacturers to obtain certification from Conformity Assessment Body in order to receive approval from the MDA.

Classification of Medical Devices in Malaysia

Medical Devices are classified under four risk categories:


Process for Registration of Medical Devices in Malaysia

I. Appoint an Authorized Representative

  • The Authorized Representative will be the license holder in Malaysia for foreign manufacturers

  • Authorized Representative will be responsible for post approval maintenance of the licenses and post-market surveillance

  • Foreign Manufacturer can act as Authorized Representative if they have their subsidiary in Malaysia. Alternatively, their Distributor or Artixio can act as Authorized Representative on behalf of the manufacturer.

II. Preparation of Common Submission Dossier Template (CSDT)

  • The technical file in CSDT format is prepared and submitted to MDA by Authorized Representative

III. Certification from Conformity Assessment Body (CAB)

  • Manufacturer needs to obtain certificate from CAB to submit to MDA for review and approval of CSDT.

  • Reference Countries: Products approved in the USA, Canada, EU or Australia will advantage in faster review of application. Certificate from CAB is mandatoy

Documents Required for Registration of Medical Devices in Malaysia

  • Summary of Medical Device

  • Information related to the Manufacturer of Device

  • Device Classification

  • CSDT

  • Post Market Surveillance Data

  • Declaration of Conformity

  • Attestation of Medical Device

Medical Devices Registration Services in Malaysia

  • Marketing Authorization Holder (MAH) Services

  • Gap Analysis

  • Regulatory Intelligence and Strategy

  • Consultation and Meeting

  • Technical File Preparation and Submission

  • Quality Management System Implementation

  • Audit Support

  • Quality Training

  • Response to Queries

  • Clinical Evaluation and Post Marketing Evaluation

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