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Registration Of Covid-19 Test Kits

  • RT – PCR
  • POCT molecular
  • RTK Ag test kits/Ag Assay/ Self-test kits
  • RTK Ab / Ab Assay
  • Neutralizing Ab Assay

Apply through Medcast 2.0 and follow the steps for registering COVID-19 test kits according to the MDA/GL/07 Guideline for Registration of COVID-19 Test Kits

Please refer to guideline MDA/GL/07 Guideline for Registration of COVID-19 IVD Test Kits for further information on the main documents for registration, such as the CSDT, EPSP, DOC, Safety and Performance reports, Labeling/IFU/Brochure, and other related documents.

No. All COVID-19 test kits will be reviewed based on the criteria set forth by MDA with the help of expert committee.

  • The manufacturer's performance report failed to meet the requirements.
  • There is insufficient information in the Performance data.
  • The manufacturer used insufficient sample size for positive and negative tests.
  • The test result did not meet the MDA's minimum cut-off for sensitivity and specificity, which had been conducted at a local testing facility.

Yes, applicants may re-apply in Medcast 2.0 for the same lot number / batch number, with a new performance report.

Applicants may begin to register now or within 6 months of the SA/CA approval letter's expiration date.

No, MDA will send an evaluation letter for the test kit. Any report submitted to the testing facility by the applicant without MDA's Evaluation letter will be rejected.

Please contact MDA (registration unit) for more information about the test's technology and principles. Make an appointment to meet with the IVD registration officers if necessary, you refer the directory in MDA’s portal to contact them. (Staff Directory)

If there is a new lot number, change notification application is required to be submitted by the applicant under:

Category 2

5.5.2 Changes in design or specifications of a registered medical device

(c) All changes in specifications (including shelf life and stability) of a registered medical device.

Evaluation letter will be provided via email for evaluation of the new lot number in testing facilities.

Professional test kits:

Performance report for the new lots should be provided. For professional test kit, new lot number will be evaluated by the manufacturer and the report of performance shall be notified to MDA.

Self-test kits:

For every new lot number, Lot to lot Evaluation is required.

It is not compulsory for the Covid-19 test kit to have obtained reference country approval. However, Approval from 5 reference countries should be stated in the CSDT under Executive Summary (Commercial Marketing History) and the related approvals should be uploaded as annexes.

The establishment should identify their scenario and provide the appropriate documentation before submitting the application.

Refer Table 3 Documents/Information required to be submitted in MDA/GL/07

Yes, all Conditional Approval and Special Access application submitted by 31st January 2022 and currently undergoing evaluation will be processed till the end.

Yes, the COVID-19 test kit will be registered in Medcast 2.0 system, a registration certificate and registration number will be issued and the validity is 5 years.

Yes, multiple AR is allowed for the registration of COVID-19 test kit on Medcast 2.0. The establishment should provide Letter of Authorization (LoA) from the manufacturer.

No. New brand requires new registration application. New proprietary name or brand shall be applied separately.

Any Adverse Event in regards to the test kit should be reported to PMSV unit.

Answer:

COVID-19 test kits are classified as Rule 3 Class C.

Rationale:

e) in determining infectious disease status or immune status, and where there is a risk that an erroneous result will lead to a patient management decision resulting in an imminent life-threatening situation for the patient.

Professional and self-test kits should be registered separately.

They are different in terms of conditions of use; application should be submitted based on different requirements.

Sample of test kits shall be submitted for evaluation to MDA upon Evaluation Officer’s request.

Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

+603 - 8230 0300

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  • Last Updated: 22 April 2024.

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