How medical devices are regulated by HSA

Medical devices, Medical devices
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What is a medical device?

Medical devices have a physical or mechanical effect on the body, and are used to diagnose, alleviate or treat medical conditions. They may also be used to measure or monitor specific functions of the body.

The spectrum of medical devices is wide-ranging. It includes devices found in hospitals and clinics, such as X-ray machines and blood pressure machines, to those that are commonly available in pharmacies, such as thermometers and pregnancy kits.

Products used for general well-being, such as body toning equipment, magnetic accessories and massagers, are not medical devices.

Classification of medical device

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, how it operates, the user, and the type of technology involved.

RISK LEVEL DEVICE EXAMPLES
Class A Low
  • Bandages
  • Wheelchairs
  • Surgical masks
Class B Low - Mid
  • Contact lenses
  • Dental crowns
  • Hearing aids
Class C Mid - High
  • X-ray machines
  • Lung ventilators
  • Hip implants
Class D High
  • Pacemakers
  • Heart stents
  • Breast implants

How are medical devices regulated in Singapore?

  • Product Registration - 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.
  • Dealers’ Licence - Manufacturers, importers and wholesalers must be licensed.
  • Adverse Events Reporting - Manufacturers, importers and wholesalers must report adverse events and product defects to HSA.
  • Prohibited Claims - Advertisements of medical devices must comply with the requirements spelled out 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 safe?

No device can be guaranteed to be completely free of risk. However, HSA’s decisions are based on sound evidence to ensure that these risks are minimised.

HSA has an adverse events monitoring programme, which draws on our network of local healthcare professionals and international regulatory partners to pick up signals of any health products that may be causing adverse effects. This system of checks and controls enables HSA to initiate timely recalls of harmful and inferior quality medical devices.

If you suspect that the medical device you are using is causing you discomfort or making you unwell, please consult a medical professional.

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