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Medical Devices Registration with Medical Device Authority (MDA) in Malaysia

Updated: May 24

The Medical Devices market in Malaysia is poised for significant growth, with projected revenue expected to reach MYR US$3,342.00m in 2024. Among the various segments, Cardiology Devices are anticipated to dominate, with a projected market volume of MYR US$539.20m in the same year. This growth trajectory is forecasted to continue steadily, with an annual growth rate (CAGR 2024-2028) of 7.81%, leading to a market volume of MYR US$4,515.00m by 2028. Malaysia's medical device market is propelled by increasing investments in healthcare infrastructure and the expanding aging population, indicating promising prospects for continued expansion.

Malaysian manufacturers contribute to 60% of the global medical gloves supply and 80% of catheters. Currently, Malaysia relies on imports for 95% of its medical devices. With a moderately higher per capita income and GDP, Malaysia experiences an increasing demand for advanced healthcare solutions.


Medical Devices Registration with Medical Device Authority (MDA) in Malaysia

Regulatory Authorities in Malaysia for Medical Devices

Medical Devices in Malaysia is 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.

Medical Device Authority (MDA) Risk Classification of Medical Devices in Malaysia

Medical Devices are classified into four risk categories:

Class

Risk

Examples

Class A

Minimal Risk

Blood Pressure Cuffs, scissors

Class B

Low to Moderate Risk


Class C

Moderate to High Risk


Class D

Highest Risk

Implantable Devices

Process for Medical Device Registration with Medical Device Authority (MDA) in Malaysia

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.

Preparation of Common Submission Dossier Template (CSDT)

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

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 mandatory

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

Navigating the process of medical device registration with the Medical Device Authority (MDA) in Malaysia requires careful attention to regulatory requirements and thorough documentation. At Artixio, we understand the complexities involved and offer comprehensive services to streamline the registration process. Our team of experts possesses the knowledge and experience needed to guide you through every step, ensuring compliance with MDA regulations and facilitating smooth market entry for your medical devices.

With Artixio by your side, you can confidently navigate the regulatory landscape and accelerate your path to market access in Malaysia. Contact us today to learn more about how we can assist you in achieving your regulatory goals and expanding your presence in the dynamic Malaysian healthcare market.

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