Related Instruments and Standards
Subsidiary legislation and exemption orders
In addition to the HP(MD) Regulations 2010, HSA may issue subsidiary legislation, exemption orders, or gazette notifications relating to specific device types, exemptions, or special provisions. These are published on Singapore Statutes Online.
Always check Singapore Statutes Online for current instruments: sso.agc.gov.sg
Relevant international standards
While Singapore does not formally mandate specific international standards by direct legislative reference (unlike the EU, which harmonises standards to EU regulations), HSA expects QMS systems and device safety assessments to align with internationally recognised standards, including:
| Standard | Relevance |
|---|---|
| ISO 13485:2016 | QMS for medical devices — required for dealer's licence |
| ISO 14971:2019 | Risk management for medical devices |
| IEC 62304:2006+AMD1:2015 | Software lifecycle processes for medical devices (relevant for SaMD) |
| IEC 62366-1:2015 | Usability engineering for medical devices |
| ISO 10993 series | Biological evaluation of medical devices |
| ISO 11135, 11137, 11607 | Sterilisation standards |
| IEC 60601 series | Safety of electrical medical equipment |
HSA's guidance documents frequently reference these standards as the basis for evaluating technical documentation.