Facilitating Compliance with Malaysia's Medical Device Regulations

Malaysia, with a population exceeding 34 million, is a significant and growing medical device market in Southeast Asia. The country's healthcare sector expansion and government initiatives to promote medical tourism are key drivers for this growth. The Medical Device Act 2012 (737) underscores the regulatory framework, mandating registration for all medical devices manufactured, imported, or sold in Malaysia.

Device Classification and Regulatory Pathways

Complying with the Medical Device Authority (MDA)

Regulatory Authority

The Medical Device Authority (MDA), under the Ministry of Health, oversees the medical device industry in Malaysia. It ensures that medical devices entering the market meet the necessary safety and performance requirements. Devices are classified from Class A (low risk) to Class D (high risk), with the classification influencing the registration process and the level of scrutiny applied.

Classification

Understanding the risk-based classification system is critical for aligning with Malaysia's regulatory requirements. The classification dictates the complexity of the technical documentation and the necessity for a Conformity Assessment Body (CAB) review.

Key Requirements

To market in Malaysia, foreign manufacturers without a local entity must:

  • Appoint a local Authorized Representative (AR) who is responsible for liaising with the MDA and managing regulatory submissions.
  • Ensure the AR holds an establishment license and Good Distribution Practice for Medical Devices (GDPMD) certification.
  • Undergo a CAB review of the technical documentation before submission to the MDA.
How We Can Help

Tailored Support for Market Entry

Our expertise is designed to streamline your market entry into Malaysia:

  • Assistance with product classification and determination of the regulatory pathway.

  • Compilation of the technical dossier and coordination of the CAB review.

  • Acting as your Authorized Representative, managing the registration with the MDA and ensuring compliance with post-market regulations.

We Provide Access To 28+ Markets Worldwide

Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.

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