MDA is Aware of Buyer Concerns About Collecting and Storing Their Personal Information When Purchasing Self-Test Covid-19 Kits in Malaysia
The purchase of self-test kits for COVID-19 requires providing personal information at sales premises authorized by MDA and KPDNHEP, and the collection of this information is a growing concern among buyers. MDA is aware of the concerns among users and would like to clarify that the requirement to record this personal information is imposed on establishments or suppliers that supply these test kits through community pharmacies, health facilities, or premises registered with the Ministry of Domestic Trade and Consumer Affairs (KPDNHEP) to facilitate contact tracking and continuous monitoring of the supply chain and distribution of self-test Kits on the market.
As stated in the MDA Medical Devices Guidance (Establishment Duties and Obligations) Regulations 2019, the activity of collecting personal information during buying this self-test kit is part of the Distribution Record requirements that must be complied with by establishments licensed with the MDA. It is the responsibility of the establishment to monitor the safety and quality of self-test kits distributed in the market up to the consumer level. Through this personal information, the establishment can take corrective action in the event of any problems related to the use of the test kits supplied, especially if it affects the control of infectious diseases such as COVID-19.
The MDA recommends that establishments and premises that are allowed to sell the COVID-19 Self-Test Kit follow these guidelines:
- The collection of personal data of the buyer by any business premises must be made based on the minimum requirement that only the name and telephone number is recorded.
- The establishment/business decides whether the information is recorded manually or digitally.
- A notice can be displayed to alert the buyer regarding the purpose of collecting their personal information. The notice must be placed in a clearly visible space.
Business premises are responsible for the buyer’s personal information and must ensure that the security of the data is preserved and always maintained.
MDA would like to urge the public not to worry about personal information collection activities for the purchase of COVID-19 self-test kits at sales premises. If there is any suspicious activity, the public can submit information to the MDA via https://femes.mda.gov.my/.