MDA Malaysia Medical Device Registration

Medical device and IVD registration in Malaysia is overseen by the Medical Device Authority (MDA) under the Ministry of Health.

The system is based on the Medical Device Act 2012, Medical Device Authority Act 2012, and Medical Device Regulations 2012. Most devices require a conformity assessment by a Malaysian Conformity Assessment Body (CAB) before registration. Class A devices are exempt from CAB assessment.

Registration applications are submitted through Malaysia’s MeDC@St system, and all devices must comply with labeling and postmarket surveillance obligations to maintain market authorization.

Malaysia medical device classification:

Devices are classified into Class A, B, C, and D based on risk. IVDs follow a parallel scheme from Class A through D. Classification determines registration and conformity assessment requirements.

Malaysia MDA device registration process

• Determine class and grouping: Apply the Malaysian classification rules. Decide how the device will be grouped (single, family, system, etc.). Class A devices are exempt from CAB review; Class B-D devices and IVDs require verification or full conformity assessment depending on reference country approval.

• Compile the technical documentation (CSDT): Prepare the Common Submission Dossier Template with all required technical, clinical, and labeling information.

• Undergo conformity assessment with a CAB (Class B/C/D)

• Submit the registration application to MDA: The local manufacturer or Authorized Representative submits through MeDC@St and pays the application fee.

• MDA reviews the submission: Target review time is 30 days for class A devices and 60 days for Class B/C/D devices.

• MDA feedback: Reply to MDA feedback within 30 days

• Pay registration fee and obtain certificate: On approval, MDA issues the registration certificate.

Other MDA registration requirements:

• Authorized Representative: Foreign manufacturers must appoint a Malaysia-based Authorized Representative to hold the registration, manage submissions and renewals, maintain documentation, and coordinate postmarket surveillance activities.

• Translation: English is generally required for both labeling and IFU. Bahasa Malaysia is mandatory for home-use devices, and MDA encourages the use of internationally recognized symbols where appropriate.

• Renewals: Device registrations are valid for five years. Renewals must be submitted through MeDC@St up to one year before expiration.

• Post-market surveillance: Manufacturers must maintain distribution records, complaint handling, adverse event reporting, field corrective actions, and recalls.

• Adverse event reporting: Mandatory reporting timelines depend on event severity. Manufacturers must investigate incidents, implement field corrective actions as needed, and submit findings and outcomes to MDA for review.

What regulatory pathways exist for registering medical devices and IVDs in Malaysia?

All devices except Class A require conformity assessment by a CAB. There are two regulatory pathways:

Verification (abridged) review: For devices already approved in the EU, UK, Australia, Canada, Japan, Singapore, Thailand, or the US. These devices undergo a shorter review, provided reference-country evidence is supplied.

Full conformity assessment: Required for devices without reference market approval. This process mirrors an EU notified body assessment and includes technical documentation review, QMS verification, and audit.

Once CAB certification is complete, manufacturers apply for registration through MeDC@St.

Who can act as the Authorized Representative in Malaysia and what do they do?

Foreign manufacturers must appoint a Malaysian Authorized Representative (AR). The AR holds the registration, interacts with MDA, submits applications and modifications, maintains device records, and ensures postmarket surveillance compliance. The AR is also responsible for submitting renewals, reporting adverse events, and coordinating recalls or field corrective actions when necessary.

What is an establishment license and do I need one as a medical device manufacturer?

An establishment license is the MDA’s required operating license for any entity that places medical devices on the Malaysian market. Under the Medical Device Act 2012, only a licensed “establishment” can import, export, manufacture, or distribute a registered device. Establishments include manufacturers, authorized representatives, importers, and distributors.

If you’re a foreign manufacturer, you don’t hold this license yourself unless you have a Malaysian legal entity. You must appoint a local authorized representative that is licensed as an establishment.