Translation from Bahasa Malaysia to English for this MDA notice listed on https://portal.mda.gov.my/announcement/871-nasihat-kepada-orang-ramai-dalam-pembelian-dan-penggunaan-kit-ujian-kendiri-covid-19.html

ADVICE TO THE PUBLIC ON THE PURCHASE AND USE OF THE COVID-19 SELF-TEST KIT

1) Following the MDA Chief Executive's press statement dated 13 February 2022 regarding public doubts on the test results using the COVID-19 self-test kit available in the market, MDA would like to inform that an investigation is underway on this matter.

2) As this investigation will take some time before a conclusion and further action on this issue can be taken, MDA would like to advise the public to take the following precautions to reduce the risk of questionable test results and help reduce efforts COVID-19 infection;

a) Obtain only MDA-approved COVID-19 self-test kits from community pharmacies, health facilities or premises registered with KPDNHEP to perform COVID-19 self-test.

Note:

- The approved test kit has gone through a rigorous evaluation process by the MDA and has been tested for its performance in selected accredited laboratories. Test kits that are not MDA approved do not go through the specified performance evaluation and testing process and their performance cannot be ascertained

- Sales at community pharmacies, health facilities or premises registered with KPDNHEP enable test kits to be detected more easily to take appropriate preventive and corrective action if any problems arise related to the performance and safety of the test kits

- Purchases from individuals or from premises other than community pharmacies, health facilities or premises registered with KPDNHEP make it difficult to prevent and correct problems that arise related to the test kit because the seller is difficult/undetectable

- Don't be fooled into buying a test kit at too cheap a price as it may be counterfeit/counterfeit, expired, damaged or obtained from illegal sources

b) Ensure that the physical condition of the test kit packaging box is in good condition and undamaged, stored in storage as recommended by the manufacturer and contains information on the name and address of the distributor, expiration date that is still valid and has not expired and instructions for use and disposal.

Note

- Physical damage to the packaging box can cause damage to the test kit and cause the results obtained to be inaccurate and questionable

- Distributor name and information to enable users to contact the distributor if there are any problems or want to make a complaint regarding the test kit purchased

- Expiration dates that are still valid and have not expired - test kits that have expired may affect their performance and test results obtained

- Storage space is important because environmental conditions, such as temperature, can affect the quality of test kits

- Use and disposal instructions as a guide to users on how to use and dispose of it properly

c) When purchasing a COVID-19 self-test kit, scan the QR code on the test kit box or write personal details on the test kit purchase book to facilitate user detection if there are problems related to the test kit.

d) The COVID-19 self-test kit shall be used in accordance with the instructions for use and disposal instructions as specified by the manufacturer either in writing or via video that can be downloaded by scanning the included QR code.

Note

- Following all the steps specified in the instructions for use fully is very important to obtain accurate test results. Improper usage will result in inaccurate and questionable results

- Improper disposal can lead to the increase and transmission of COVID-19 and environmental pollution

e) Record test results in MySejahtera to enable the authorities to take further action in the management of COVID-19

f) Inform any questionable test results using the COVID-19 self-test kit by participating in a survey (survey) on performance related to the performance of the COVID-19 self-test kithttps://forms.gle/zFyJMT8zzH2CAdjHA.

3) MDA hopes that the precautions mentioned above will reduce the risk of questionable test results and help reduce COVID-19 infection.

Medical Device Authority

Ministry of Health Malaysia

15 February 2022

Source: MDA Malaysia

-

In accordance with Medical Device Authority (MDA Malaysia Ministry of Health, Malaysia), MyMedicNews serves as the leading online media in the medical device industry for Malaysia and the ASEAN region. We provide a creative one-stop web portal to deliver the latest news and product development in the medical device industry. Through our portal, key industry players can deliver business information, product, and services effectively to relevant target audience.

Disclaimer: All content is for informational or educational purposes only, and does not substitute professional medical advice or consultations with healthcare professionals. Medical device advertisements and their content are intended for Healthcare Professionals only. More information related to Malaysia medical device news, products, registration, and regulations is available on Medical Device Authority.