Be wary of misleading health claims for medical products and devices
Medical devices are health products used on humans with a physical or mechanical effect on the body generally to diagnose, alleviate or treat a medical condition or are used to measure or monitor functions of the body. Products used for maintaining or supportive general wellbeing, such as body toning equipment, magnetic accessories and massagers, are NOT medical devices.
Medical devices are classified into four risk classes – class A to D with class A being the lowest risk class. This classification is based on the intended purpose of the medical device, mode of operation and the user, and also the device technologies.
Device Examples: bandages, wheelchairs, surgical masks
Device Examples: contact lenses, dental crowns, hearing aids
Device Examples: X-ray machines, lung ventilators, hip implants
Device Examples: pacemakers, heart stents, breast implants
No device can be guaranteed to be completely free of risk. However, sound evidence underpins HSA's decisions to ensure that these risks are minimised. There is also a post-market surveillance programme in place to monitor the safety of medical devices. Our adverse reaction monitoring programme draws on HSA's network of local healthcare professionals and international regulatory partners to pick up signals of any health products that may be causing adverse reactions. This system of checks and controls has enabled HSA to initiate timely recalls of harmful and inferior quality medical devices.
If you suspect a medical device is causing you discomfort or making you unwell, please consult a doctor or dentist and report it to HSA.
How can you be a smart consumer? How do you know if a product is a medical device? How do you know it works properly as intended and is acceptably safe? How do you choose a medical device and what precautions should you take?
All medical devices registered with HSA are listed in the Singapore Medical Device Register (SMDR).
For more information on the regulation of medical devices in Singapore, you may refer to the HSA Website.
If you suspect that the medical device you are using makes you unwell, see your doctor or dentist immediately.
You can also get in touch with HSA at Tel: 1800 2130 800 or write to HSA.
This article was last reviewed on 04 Dec 2019
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