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
Medical devices must be registered with HSA to ensure they meet the regulatory requirements before they can be sold, unless they are class A devices which are exempted
Manufacturers, importers and wholesalers are required to be licensed
Manufacturers, importers and wholesalers are required to report adverse events and product defects to HSA
Advertisements of medical devices must comply with the requirements stipulated under the law, including the prohibition of advertisements making reference to a specified list of serious medical conditions such as cancer and diabetes.
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?
Ensure the device is suitable for your medical condition
Read the instructions provided carefully before purchasing and using the device
Always consult your doctor or dentist if you have any questions
Stop using the device immediately if you experience any discomfort or injury
Report any discomfort or injury to your doctor or dentist; no medical device is 100% safe
Forgo your prescribed medical treatment
Buy from dubious sources (e.g. unknown websites, unfamiliar sellers, makeshift stalls etc.)
Buy medical devices with questionable claims and sensational promises such as:
Claims to cure a wide range of diseases (e.g. diabetes, hypertension and cancer)
No-risk, money-back guarantee
All medical devices registered with HSA are listed in the Singapore Medical Device Register (SMDR).
Singapore Medical Device Register
Check with the retailer or dealer
For more information on the regulation of medical devices in Singapore, you may refer to the
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
Wednesday, December 4, 2019
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