Watsons is selling an unregistered Blood Pressure Monitor (BPM). PLEASE STOP if you, your family or friends are using or intending to buy the above pictured device sold exclusively at Watsons. Using it could result in medical complications.
The “MEDIX Automatic Digital Blood Pressure Monitor” is a controlled medical device which is not listed on the Singapore Medical Device Register (SMDR). Being unlisted and thus unregistered simply means that documentation for its safety and efficacy has not been verified by the Health Sciences Authority (HSA) and could result in false readings which could lead to medical complications for those relying on it.
The Health Products Act (HPA) in Singapore was introduced in 2012. It governs the import, distribution, marketing and sale of controlled medical devices in order to protect the people of Singapore from errant manufacturers, importers, distributors and retailers. There are heavy fines and jail time for offences. All diagnostic medical devices such as blood pressure monitors are categorized as controlled devices as they pose a health risk to users should they not be able to provide a reliable reading. These devices must be registered before any importation, distribution, marketing and sale is permitted. Nonetheless, its unregistered and therefore illegal status overshadows questions related to its safety and efficacy.
A police report with evidence from HSA’s SMDR listing has been lodged against Watsons and its supplier. The public could have been adversely affected by this unverified medical device and has no idea that it could be due to this device. Hence, there is probably no Adverse Events or safety issue records with HSA for this device.
Those who have this device should stop using it, and seek clarification and redress from HSA and Watsons.
Health Sciences Authority
Tel: 68663560, Email: [email protected]
Tel: 63398456, Email: [email protected]