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Malaysia Medical Device Regulation

Malaysia Medical Device Regulation

Medical Device Registration in Malaysia: Navigating MDA Regulations

Updated on 26/01/24

Regulatory Authority: Medical Device Authority (MDA)

MDA is the government agency entrusted to serve the Malaysia medical device’s industry. It is a federal statutory agency under the Ministry of Health Malaysia to implement and enforce the Medical Device Act 2012 (Act 737). The main objectives of the Act are to address public health and safety issues related to medical devices and to facilitate medical device trade and industry.

In February 2005, the Cabinet approved the proposal for the development and implementation of medical device regulatory program. Subsequent to the Cabinet decision, Medical Device Authority Act 2012 (Act 738) and Medical Device Act (Act 737) have been published in the Gazzete on 9th February 2012.

 MDA was established under Act 738 on 15 March 2012 and has been officially and fully in operation since 16 June 2012.

Link for Regulatory Authority: https://portal.mda.gov.my/

Local Regulation: Medical Device Act 2012 (Act 737)

Classification: Class A, B, C and D

Listing or Registration Requirements:

  • Appoint a local authorized representative (LAR)
  • Ensure products conform to the Essential Principle of Safety & Performance (EPSP).
  • Engage an accredited Conformity Assessment Body (CAB). CAB must be different from CAB in foreign countries.
  • Complete application on MeDC@St system including general information, Common Submission Dossier Template (CSDT), Declaration of conformity (DoC), and a certificate of Conformity of the quality management system (QMS)
    • Quality management system (QMS)
    • System post-market surveillance (PMS)
  • CSDT
    • Class B/C: clinical evidence, if required
    • Class C/D: clinical evaluation
  • MDA verifies classification and upon approval issues a certificate and assigns a registration number.

Documents Required:

  • General information on the medical device
  • Information on manufacturer of medical device
  • Grouping of medical devices
  • Common Submission Dossier Template (CSDT)
  • Post-market vigilance history
  • Declaration of conformity
  • Attestation for medical device registration

Registration Timeline:

  • Class A – 6 to 8 weeks
  • Class B, C and D – 3 to 6months

Application fee:

  • RM100 for Class A
  • RM250 for Class B
  • RM500 for Class C
  • RM750 for Class D

Registration fee: Fees Structure

CAB report fee: Varies depending on the Conformity Assessment Body (CAB)

License Validity: 5 years

Additional Comments: Local testing is not required for medical device registration in Malaysia. Clinical studies are generally not required for registration in Malaysia.

Who should make this communication:

  • Manufacturer
  • Authorized Representative

When to make this communication: Before placing a medical device into the market.

Market overview:

The anticipated revenue in the Medical Devices market in Malaysia is expected to reach US$3,342.00 million in 2024.

The medical device market in Malaysia is experiencing rapid growth, driven by favorable government policies and an expanding aging population.

Requirements for importing medical devices into Malaysia:

An Establishment License for importers from the Medical Device Authority (MDA) through the Medcast system is exclusively open to local Malaysian companies. To qualify, the importer needs a valid Importer’s License and is permitted to import only those medical devices that have been duly authorized by the Local Authorized Representative (LAR). The LAR is required to issue a Letter of Authorization for Importer on their letterhead, covering all products and models of the devices intended for importation. The flexibility of market access allows the LAR to authorize more than one importer for your device.

Additionally, the appointed importer must possess a valid Good Distribution Practice for Medical Devices (GDPMD) certification, aligning with the scope relevant to your specific medical device.

How OMC Medical can assist you with the process

  • Act as your Authorized representative

Why Choose Us

  • Working towards client satisfaction
  • Cost effective solutions
  • Project completion before deadline
  • Quality Regulatory affairs solutions

Contact us for free consultation: [email protected]