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Conditional Approval for Covid19 RTK (Self-Test)

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CONDITIONAL APPROVAL FOR COVID-19 RTK (SELF-TEST)

  Guideline Document Conditional Approval for Covid-19 RTK (self-test) 
Form A - Application Form for Conditional Approval for Covid-19 RTK (Self-Test)
Form B - Evaluation Report Result Form for Conditional Approval for Covid-19 RTK (Self-Test)

• E-mail: ca.covid19@mdb.gov.my or ca.covid19@mda.gov.my / Contact Number : +603 - 8230 0376
• In order to prevent email deliverability issues due to file size limitation, please submit the conditional approval application to ca.covid19@mdb.gov.my
• Please use FORM A for submission of Conditional Approval for Covid-19 RTK (self-test) application.

 

Additional Information on Conditional Approval for Covid-19 RTK (self-test)

No

Description of fees for Conditional Approval for Covid-19 RTK (self-test)

Fee Payable (RM)

1

Application Fee

150

2

Conditional Approval Letter Fee

1000

 

 New flow chart test kit C19

Instant Guide to Conditional Approval For Covid-19 RTK (self-test)

No (steps)

Explanatory Notes

1

The applicant must submit a complete Application Form (Form A) for Conditional Approval for Covid-19 RTK (self-test) together with the Application Fee RM 150 (Bank Draft).

Note: Payment shall be made through Bank Draft to “KUMPULAN WANG PIHAK BERKUASA PERANTI PERUBATAN”. Please bring the Bank Draft together with the form A to MDA address.

2

The Secretariat will acknowledge applicant for the request for Conditional Approval for Covid-19 RTK (self-test) via email.

3

Screening of Application by MDA Evaluation Team and for incomplete applications it will be returned to the applicant for more information.

4

The application will be evaluated using the Evaluation checklist (CRITERIA CHECKLIST FOR COVID-19 RTK (SELF-TEST) developed by MDA based on WHO and Recognized countries criteria) by the Evaluation team.

a) Applications that do not meet the requirements will be reviewed and rejected.

b) Application that complete and meets the requirements will be tabled in the Expert Committee (Jawatankuasa Expert Penilaian Akses Khas Covid-19 Ivd Test Kit) Meeting.

5

The expert committee will review the content of each application in the checklist and make a decision on the IVD test kits' performance. During this meeting, the test kit that meet the requirements will be assign to the testing facility.

6

The Applicant will be notified of the Assessment Result for the application that meet the requirements via email together with an Evaluation Letter and Form B.

7

The application that receives the evaluation letter must go through evaluation testing with the designated assigned testing facility.

8

MDA Evaluation Team will receive the Applicant's Evaluation Report and Form B.

9

The test kits that meet the requirements for Recommended for Use will be endorsed during the meeting or by circulation based on the results of the evaluation report.

i)       Test kits that are not suggested for use will be refused and will not be permitted for usage, with an email notification.

ii)      Test kits that are recommended for use will be verified by Verification Officer (VO)

10

The applicant will be notified of the decision through email.

11

MDA Evaluation Team will issue a payment advice to the Finance Department (MDA) and the Finance Department will issue an invoice for Conditional Approval fee (RM 1,000) to the applicant.

12

Submission of Bank Draft by applicant to Finance Department. Payment (Conditional Approval Fee) is accepted by the Finance Department, which notifies the Registration Unit.

13

For the validated test kits, MDA will issue a Conditional Approval Letter for Covid-19 RTK (self-test).

Print

  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
  +603 - 8230 0200 
  mdb@mda.gov.my

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  • Last Modified: 03 August 2021.
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