Singapore HSA Risk Classification Rules for Medical Devices

1. Purpose of the Classification Rules

HSA uses a set of 16 rules to classify medical devices into four risk classes (A, B, C, D). The classification reflects the potential risk to patients or users, guiding the level of regulatory scrutiny, including conformity assessment and registration requirements. Higher-risk devices undergo more rigorous evaluation. https://www.hsa.gov.sg/medical-devices/registration/risk-classification-rule

2. General Principles

Classification is based on:

• Intended purpose as stated by the manufacturer
• Degree of invasiveness
• Duration of contact with the body
• Whether the device is active (energy source) or non-active
• Degree of central circulatory or nervous system involvement
• Incorporation of medicinal substances or biological materials

Rules are applied sequentially; the highest applicable class prevails. https://www.hsa.gov.sg/medical-devices/registration/risk-classification-rule

3. Key Classification Rules Summary

The 16 rules are grouped as follows:

• Non-invasive devices (Rules 1–4): Cover items like dressings, disinfectants, and devices for channeling fluids.
• Invasive devices (Rules 5–8): Address surgically invasive devices, implantable devices, and those for modifying biological material.
• Active devices (Rules 9–13): Include energy-emitting devices, diagnostic imaging systems, and devices for therapy or diagnosis.
• Special rules (Rules 14–16): Cover devices incorporating medicinal substances, biological origin materials, or those for contraception/sterilization. https://www.hsa.gov.sg/medical-devices/registration/risk-classification-rule

4. Examples by Rule and Class

• Rule 1 — Non-invasive devices for storage/transport (e.g., blood bags): Class A or B depending on sterilization.
• Rule 5 — Surgically invasive short-term devices (e.g., catheters): Class B or C.
• Rule 8 — Implantable or long-term surgically invasive devices (e.g., joint replacements): Class C or D.
• Rule 9 — Active therapeutic devices (e.g., radiotherapy equipment): Class C or D.
• Rule 16 — Devices with medicinal substances (e.g., drug-eluting stents): Class D. https://www.hsa.gov.sg/medical-devices/registration/risk-classification-rule

5. Special Considerations

• Software as a medical device follows the same rules based on intended purpose.
• Combination devices are classified according to the principal mode of action.
• If multiple rules apply, the highest class is assigned.
• Borderline products may require HSA consultation for determination. https://www.hsa.gov.sg/medical-devices/registration/risk-classification-rule

6. Impact on Registration

The assigned class determines:

• Conformity assessment route
• Required technical documentation
• Review timeline (notification for Class A vs. full evaluation for Class D)
• Authorized Representative responsibilities https://www.hsa.gov.sg/medical-devices/registration/risk-classification-rule

Accurate classification is essential for compliance and timely market access in Singapore’s risk-proportionate regulatory framework. https://www.hsa.gov.sg/medical-devices/registration/risk-classification-rule