Class A — Exemption and Notification
The exemption
Class A medical devices — the lowest-risk class under Singapore's four-tier risk classification — are exempt from product registration. They do not need to appear on the Singapore Medical Device Register (SMDR).
This exemption is set out in the Health Products (Medical Devices) Regulations 2010 and confirmed on the HSA regulatory overview page:
"All medical devices will require registration with us before they can be supplied in Singapore, except for Class A low risk medical devices, which are exempted from product registration."
What Class A still requires: product notification
The exemption from registration does not mean there is no obligation at all. Manufacturers and importers of Class A devices must submit a product notification application via the SHARE portal before the device is supplied in Singapore.
This is a common source of confusion. The distinction is:
| Class A | Class B / C / D | |
|---|---|---|
| Registration required? | ❌ No | ✅ Yes |
| Product notification required? | ✅ Yes (via SHARE) | N/A — registration covers this |
| Dealer's licence required? | ✅ Yes (importer/wholesaler/manufacturer) | ✅ Yes |
| Fee | Lower than registration fees | Registration fee applies |
| HSA evaluation of technical content | Minimal — administrative notification | Full, Abridged, Expedited, or Immediate depending on class and route |
What is a Class A device?
Class A covers devices with the lowest risk profile — generally devices that do not directly contact the patient's body, or do so only in a non-invasive way that poses minimal risk. Examples include:
- Non-sterile bandages and wound dressings (non-invasive);
- Tongue depressors;
- Patient examination gloves (non-sterile);
- Hospital furniture with a medical purpose (e.g. adjustable beds);
- Stethoscopes;
- Wheelchairs and basic walking aids;
- Corrective spectacle lenses (non-contact).
Classification is always determined by applying the HP(MD) Regulations classification rules, not by assumption. If there is any doubt, use HSA's risk classification tool.
Sterile Class A devices
Class A devices that are supplied in a sterile state carry additional obligations. Sterility is a significant safety parameter, and HSA treats sterile Class A devices differently from non-sterile Class A devices. Check the current HSA guidance and SHARE requirements for sterile Class A products, as additional QMS evidence relating to sterilisation may be required.
Class A and the dealer's licence
The exemption from registration does not exempt Class A device dealers from the dealer's licence requirement. A company importing Class A devices into Singapore for supply must still hold an importer's dealer's licence, meet GDP requirements, and have an appropriate QMS in place.
How to submit a Class A product notification
- Log in to the SHARE portal.
- Select the Class A product notification application type.
- Complete the product details — device name, intended purpose, manufacturer, risk classification.
- Submit and retain the notification reference number.
HSA does not conduct a substantive evaluation of Class A notifications in the way it evaluates Class B–D registration applications. The notification is an administrative record that the device is in the Singapore market.