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.
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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