Health Products (Medical Devices) Regulations 2010
Overview
The Health Products (Medical Devices) Regulations 2010 (HP(MD) Regulations) is the principal subsidiary legislation under the Health Products Act (Cap. 122D) that provides the detailed operational requirements for medical device regulation in Singapore.
Full text: sso.agc.gov.sg/SL/HPA2007-S436-2010
Structure
| Part | Content |
|---|---|
| Part 1 | Preliminary — definitions specific to medical device regulation |
| Part 2 | Classification of medical devices — the rules and factors for determining Class A, B, C, or D |
| Part 3 | Registration of medical devices — product registration requirements, evaluation routes, Class A notification |
| Part 4 | Dealer's licences — who needs a licence, application requirements, conditions, renewal, cancellation |
| Part 5 | Post-market obligations — adverse event reporting, FSCAs, change notifications |
| Part 6 | Miscellaneous provisions |
| Schedule 1 | Classification rules for medical devices |
| Schedule 2 | Classification rules for IVD medical devices |
| Schedule 3 | Information required for registration applications |
Key schedules
Schedule 1 — Classification rules for medical devices: The rule-based framework for classifying general medical devices into Classes A, B, C, and D. Applies the GHTF/IMDRF risk-based model using invasiveness, duration of contact, active/non-active status, and special characteristics as classification factors.
Schedule 2 — Classification rules for IVDs: The separate classification framework for in vitro diagnostic devices, based on intended use, analyte type, and clinical risk of incorrect results.