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Conditional Approval For Covid-19 RTK (self-test)

The COVID-19 rapid test kit (self-test)) is used as a self-administered screening test. It does not replace the reverse-transcription polymerase chain reaction (RT-PCR) for COVID-19 real-time diagnostic function, but it does have the advantage of determining patient status immediately and conveniently

A self-test is a rapid antigen test that you can carry out yourself at home while professional for use kit is in point of care settings for both symptomatic and asymptomatic people. This can help healthcare professionals identify a SARS-CoV-2 infection in people

Applicant is required to submit completed copies of the following documentation:

a) Letter of Authorization from Foreign Manufacturer with list of devices;
b) Valid quality management system (ISO 13485) certificate;
c) Analytical performance report (analytical sensitivity, analytical specificity, interference and/or other analytical tests);
d) Raw data of clinical performance full report (clinical sensitivity, clinical specificity, method comparison- performance validation (cross table), and layman usability);
e) Medical device labelling, IFU & product brochure, text hyperlink or QR Code link to audiovisual demonstration;
f) Disposal procedure (e.g. by providing disposable bag with disinfectant for the disposal of the test kit, and any other instructions for disposal);
g) Methods of reporting self-test Covid-19 test result. (Positive, Negative and inconclusive); and
h) Declaration of Conformity (refer guidance document MDA/GD/0025).

1)Submission of complete Application Form A and application fee (Bank Draft rm150)
2)The Secretariat receiving the application will send an acknowledgement to the applicant
3)Screening of Application and for incomplete applications it will be returned to the applicant for more information/documentation.
4)The application will be evaluated
a) Applications that do not meet the requirements will be rejected.
b) Applications that meet the requirements will be moved to the Expert Committee (Jawatankuasa Pakar Penilaian Akses Khas Covid-19 IVD Test Kit) Meeting.
5)Assessment by Covid-19 Expert Committee
6)Notification of Asessment Result by MDA via email
7)Evaluation of Test Kits at Testing Facilities
8)Testing facilities submit Evaluation Report to MDA
9)Decision (Endorsement by Expert Committee)
10)The applicant will be notified of the decision through email.
11)Issuance of Payment Invoice for Conditional Approval Fee (RM 1000) by MDA
12)Submission of Bank draft
13)Issuance of Conditional Approval Letter for Covid-19 RTK (self-test)?

You have to submit Clinical Performance Report:
• Clinical Sensitivity
• Clinical Specificity
• Method Comparison- Performance Validation (Cross table)
-The clinical performance of the Covid-19 RTK (self-test) by patient self-testing, and professional testing after supervised self-collection or professional collection.
-Cross table for the method comparison of Covid-19 RTK (self-test) against RT-PCR
• Layman usability

Laymen study is used to review and demonstrate the easy use of the COVID-19 Ag Rapid Saliva Test Device for self-testing. The aim is to check whether the test, including the instructions for use, is easy to understand and in use and whether it can be recommended for personal use

The application being rejected if full performance report/Clinical study report does not meet performance criteria.

RTK is faster and less intrusive than a Polymerase Chain Reaction (PCR) test. This makes it easy for the public to use to test themselves if needed. In general, RTK have a sensitivity (ability of a test to identify patients with the disease) of about 80% for cases with higher viral loads and a specificity (ability of a test to identify patients without the disease) range of 97-100%. As the sensitivity and specificity of RTKs are lower as compared to PCR tests, if you test RTK-positive or invalid twice, you will need to follow up with a confirmatory PCR test at clinic. You should not repeat the RTK. Even if you do test RTK-negative in the repeated test, it may be a false negative result and hence you need to go for a confirmatory PCR test.

The COVID-19 RTK (self-test) kit granted conditional approval shall only be sold by registered Pharmacies and healthcare institutions registered with Cawangan Kawalan Amalan Perubatan Swasta (CKAPS)

Online sales are only allowed for registered pharmacies and health institutions and by abiding with the manufacturer’s instructions relating to storage and delivery conditions.

Pihak Berkuasa Peranti Perubatan Malaysia,
Kementerian Kesihatan Malaysia,
Aras 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

+603 - 8230 0300

+603 - 8230 0200

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  • Kemaskini Terakhir: 24 Julai 2024.

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