How medical devices are regulated by HSA and their safe use

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.

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.

Medical devices – do’s and don’ts

Some medical devices can be easily obtained from pharmacies or retail stores, and can be operated or managed yourself, such as contact lenses, hearing aids, wound dressings, etc. As medical devices can have an impact on your health, it is important to use them in a safe and effective manner.

Do:

• Ensure the device is suitable for your medical condition. Your doctor is the best person to consult if you need advice on how to use or manage medical devices.

• Use the device according to the instructions provided. Improper usage of medical devices can make you unwell or delay unnecessary treatment.

Don’t:

• Forgo your prescribed medical treatment. Medical devices are not meant to replace specific treatments set out by your doctor.

• Buy from dubious sources (e.g. unknown Internet sites, makeshift stalls etc.). For safety purposes, manufacturers, importers and wholesalers in Singapore must be licensed, and medical devices must be registered with HSA to ensure they meet regulatory requirements before they can be sold. Don’t risk your health with unregistered medical devices.

• Buy medical devices which make sensational claims and promise miraculous cures. To prevent misconceptions, advertisements of medical devices are prohibited from making reference to a specified list of serious medical conditions, such as cancer and diabetes. Serious medical conditions need to be treated by medical professionals.