Malaysia Reinforces Control on Influenza Test Kits: Professional Use Only

31 October 2025 – Cyberjaya, Malaysia

The Medical Device Authority (MDA), under the Ministry of Health (MOH), has issued a media statement to reinforce regulatory control and monitoring of influenza test kits currently available in the Malaysian market. The announcement clarifies that all influenza test kits are classified as In Vitro Diagnostic (IVD) Medical Devices intended strictly for use by trained healthcare professionals.

This means these test kits are not approved for self-testing and must not be used by the general public without professional supervision.

Why the Restriction Matters

Incorrect use of influenza test kits outside healthcare settings can lead to:

• Inaccurate test results

• Misinterpretation of health status

• Inappropriate treatment decisions

• Unnecessary health risks to individuals and communities

The MDA advises individuals experiencing symptoms such as fever, sore throat, coughing, or respiratory discomfort to seek evaluation at licensed healthcare facilities for proper diagnosis and care.

Compliance Requirements for Healthcare Facilities

Healthcare facilities, both public and private, must ensure the following:

Requirement Details

Source of Supply Kits must be purchased only from manufacturers, Authorised

Representatives, licensed importers, or distributors.

Registration Status Kits must be registered with MDA under the Medical Device Act 2012 (Act 737). Registration status can be verified through the public search portal: https://mdar.mda.gov.my/

No E-Commerce Purchase: Online sales or purchases of these kits via e-commerce platforms are strictly prohibited.

Advertising and Promotion Restrictions

Any medical device designated for professional use only cannot be marketed, displayed, or promoted publicly without prior approval from the MDA.

Promotion of such devices to the general public is a violation under:

• Section 44, Medical Device Act 2012 (Act 737)

• Medical Device (Advertising) Regulations 2019

• Consequences of Non-Compliance

  
  

The sale or distribution of unregistered influenza test kits is an offence under Section 5(1) of Act 737.

MDA has stated that strict enforcement actions will be taken against violators, including surprise inspections across private and public healthcare facilities.

Key Takeaway

This announcement reinforces Malaysia’s commitment to:

✔ Safeguarding public health

✔ Ensuring the reliability of diagnostic testing

✔ Maintaining regulatory compliance and oversight

✔ Preventing misuse and misinterpretation of IVD medical results

Healthcare providers, distributors, and industry players should review their procurement, advertising, and supply practices to ensure full alignment with this directive.