The Medical Device Authority (MDA) wishes to inform all stakeholders that the exemption from the Conformity Assessment Process by a Conformity Assessment Body (CAB) for the registration of COVID-19 Test Kits is no longer applicable following the withdrawal of the relevant circular letter on 23 February 2024.
All subsequent registration applications, including applicable re-registration applications for COVID-19 Test Kits, shall comply with the current medical device registration requirements and undergo conformity assessment by a CAB.
Read the full update here:
https://portal.mda.gov.my/index.php/documents/ukk/4221-update-on-the-re-registration-requirements-for-covid-19-test-kits-under-the-exemption-from-the-conformity-assessment-process-by-the-conformity-assessment-body-cab/file
Purpose of the Update
To inform stakeholders that the CAB conformity assessment exemption for COVID-19 Test Kit registration is no longer applicable.
To clarify the re-registration requirements for COVID-19 Test Kits under the current MDA medical device registration framework.
Scope of Application
This update applies to all subsequent registration applications and applicable re-registration applications for COVID-19 Test Kits in Malaysia.
It is relevant to manufacturers, Authorized Representatives, importers, distributors, and registration holders managing COVID-19 Test Kit registration or re-registration through MeDC@St.
Key Highlights
All subsequent registration applications, including applicable re-registration applications for COVID-19 Test Kits, must comply with the current medical device registration requirements.
COVID-19 Test Kits must undergo conformity assessment by a CAB in accordance with applicable MDA guidance documents, including:
- MDA/GD/0031
- MDA/GD/0068
- MDA/GD/0070
A valid CAB Conformity Assessment Report and Certificate of Conformity shall be submitted as part of the registration application requirements.
Re-Registration Requirements for COVID-19 Test Kits via MeDC@St
COVID-19 test kits with an existing registration record in MeDC@St may submit a re-registration application through the existing registration record.
The applicable conformity assessment pathway depends on whether the product has existing Pre-Market Approval.
| Existing Pre-Market Approval | Applicable Pathway | Required CAB Documentation |
| Yes | Initial Certification via Verification Pathway | Initial Certification Report in accordance with MDA/GD/0068 and MDA/GD/0070 |
| No | Full Conformity Assessment | Full Conformity Assessment Report in accordance with MDA/GD/0031 |
Implications to Clients
Applicable registration or re-registration applications for COVID-19 Test Kits must undergo conformity assessment before submission to MDA.
Clients are encouraged to initiate the re-registration application with Andaman early to allow sufficient time for CAB assessment and avoid delays in renewal or market continuation.
Registration holders should review their existing product approval status, identify the applicable conformity assessment pathway, and prepare the required CAB documentation before submission.
Effective Date
29 June 2026
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Malaysia, please contact sales@andamanmed.com.