Medical device manufacturers, importers and distributors should take note:
On June 26, 2026, the Malaysian Medical Device Authority (MDA) issued a new announcement introducing significant changes to the registration and compliance requirements for COVID-19 test kits.
This marks a major shift in the regulatory approach to COVID-19 test kits in Malaysia. The conformity assessment exemption that previously provided a fast-track route for market access has now been officially withdrawn.
For medical device companies planning to enter or expand their presence in Malaysia, the regulatory approach has changed and corresponding compliance strategies should be adjusted accordingly.
1. Key Change: The Exemption Has Officially Been Withdrawn
During the COVID-19 pandemic, MDA allowed certain COVID-19 self-test kits to enter the Malaysian market through simplified self-declaration or Emergency Use Authorization (EUA) mechanisms in response to urgent public health needs.
As the global pandemic has transitioned into routine management, Malaysian regulators are bringing these products back under the regular regulatory framework established under the Medical Device Regulations.
Following the withdrawal of the notification issued on February 23, 2024, MDA has officially revoked the previous exemption from the conformity assessment process for COVID-19 self-test kits.
The exemption certification procedure previously conducted through Conformity Assessment Bodies (CABs) for COVID-19 test kit registration is no longer applicable.
This means that relevant products must now undergo formal assessment by an MDA-recognized CAB before they can be placed on the Malaysian market.
2. Current Registration and Compliance Requirements
All registration applications for COVID-19 test kits submitted to MDA must now be supported by a valid CAB conformity assessment report.
Manufacturers can no longer rely solely on internal technical documentation and self-declaration. An independent third-party conformity assessment is required.
Accordingly, all subsequent COVID-19 test kit registration applications must comply with the applicable registration requirements and CAB conformity assessment procedures.
The conformity assessment must be conducted by an eligible CAB in accordance with the applicable MDA guidance documents, including:
- MDA/GD/0031
- MDA/GD/0068
- MDA/GD/0070
The registration application must include a valid CAB conformity assessment report and CAB certificate of conformity, as applicable.
3. Special Considerations for Existing Registration Records
For COVID-19 test kits that already have registration records in the MeDC@St system, manufacturers may submit applications for re-registration based on the applicable conformity assessment pathway.
| Pre-Market Approval Required? | Applicable Conformity Assessment Pathway | Required CAB Report |
|---|---|---|
| Yes | Initial Certification via Verification Pathway | Initial certification report issued in accordance with MDA/GD/0068 and MDA/GD/0070 |
| No | Full Conformity Assessment | Full conformity assessment report issued in accordance with MDA/GD/0031 |
Manufacturers should therefore review their existing registration status and determine the appropriate conformity assessment pathway before submitting a new application.
4. Impact on the Industry and Compliance Recommendations
This regulatory adjustment is not an isolated development. It reflects a broader trend among regulatory authorities toward returning IVD products to standard regulatory oversight following the exceptional measures introduced during the pandemic.
Impact on the Industry
Increased costs
CAB conformity assessment will introduce additional assessment fees and regulatory preparation costs, potentially extending the overall product registration timeline.
Higher technical requirements
MDA/GD/0070 places greater emphasis on clinical evidence and analytical performance evaluation. Manufacturers should reassess whether their existing clinical and analytical data are sufficient to support registration in Malaysia.
Compliance Recommendations
Compliance is not the end of market access—it is the starting point.
As Malaysia’s regulatory requirements for IVD products continue to become more structured and detailed, manufacturers should prepare their technical documentation and conformity assessment strategy in advance and ensure that their registration pathway is aligned with the latest MDA requirements.
For companies planning to enter or expand in the Malaysian market, early regulatory assessment can help minimize delays, control registration costs and ensure a smoother market entry process.
Conclusion
The withdrawal of the COVID-19 test kit conformity assessment exemption marks an important transition from pandemic-era regulatory flexibility back to the standard Malaysian medical device regulatory framework.
Manufacturers, importers and distributors should review their existing COVID-19 test kit registrations, identify the applicable CAB conformity assessment pathway, and prepare the required technical and clinical evidence accordingly.
The era of special regulatory treatment for COVID-19 test kits is coming to an end. Companies should update their Malaysia registration strategies promptly to ensure continued compliance and market access.
For further questions regarding medical device and IVD registration in Malaysia, please feel free to contact Grzan Group Limited.