Do You Know What a Medical Device is?

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.

Classification of 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.

Class A – Low Risk Level

Device Examples: bandages, wheelchairs, surgical masks
 

Class B– Low to Mid Risk Level

Device Examples: contact lenses, dental crowns, hearing aids
 

Class C – Mid to High Risk Level

Device Examples: X-ray machines, lung ventilators, hip implants
 

Class D – High Risk Level

Device Examples: pacemakers, heart stents, breast implants 

How Are Medical Devices Regulated in Singapore?

• 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.

Are All Medical Devices Available in Singapore 100% Safe?

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.

Make Safe and Informed Decisions

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?

Do

• 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
   

Don't 

• 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
  • "Miracle cure"

How to Find Out if Your Medical Device is Registered in Singapore?

All medical devices registered with HSA are listed in the Singapore Medical Device Register (SMDR). 

• Access Singapore Medical Device Register
• Check with the retailer or dealer

Where Can I Obtain More Information?

For more information on the regulation of medical devices in Singapore, you may refer to the HSA Website.

What Should I Do When Problems Arise?

If you suspect that the medical device you are using makes you unwell, see your doctor or dentist immediately.
You can also submit your feedback to HSA via this form: Enquiry/Feedback on Health Products | FormSG