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Monkeypox Test Kits

  • Reverse transcription polymerase chain reaction (RT – PCR)
  • Rapid Test Kit Antigen (RTK Ag) /Antigen Assay
  • Rapid Test Kit Antibody (RTK Ab) / Antibody Assay

Apply through Medcast 2.0 and follow the steps for registering Monkeypox test kits according to the MDA/GL/09 GUIDELINE FOR REGISTRATION OF ORTHOPOXVIRUS (MONKEYPOX) IVD TEST KITS.

Please refer to guideline MDA/GL/09 GUIDELINE FOR REGISTRATION OF ORTHOPOXVIRUS (MONKEYPOX) IVD TEST KITS for further information on the main documents for registration, such as the CSDT, EPSP, DOC, Safety and Performance reports, Labelling/IFU/Brochure, and other related documents.

Yes. It is necessary to appoint CAB to conduct conformity assessment.

  • Medical devices that have been approved by regulatory authorities or notified bodies recognized by Medical Device Authority (MDA) is required to conduct conformity assessment by way of verification by any registered CAB.
  • Medical devices which have not obtained any approval by regulatory authorities or notified bodies recognized by Medical Device Authority (MDA) is required to undergo full conformity assessment by any registered CAB
  • 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.
  • Clinical Studies does not meet requirements as per ISO 20916: 2019 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice.

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

It is not compulsory for the Monkeypox 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.

Refer Table 2 Documents/Information required to be submitted in MDA/GL/09

Yes, the Monkeypox 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.

Monkeypox 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.

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Ministry of Health Malaysia,
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  • Last Updated: 22 April 2024.

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