HSA

The Health Sciences Authority (HSA) is Singapore's statutory board under the Ministry of Health, established to regulate health products including medical devices, pharmaceuticals, and blood products. HSA's Medical Device Branch oversees the entire lifecycle of medical devices from pre-market evaluation to post-market surveillance.

Device classification:

HSA adopts a risk-based classification system aligned with the ASEAN Medical Device Directive (AMDD):
- Class A - Low risk devices (e.g., non-invasive instruments, bandages, examination gloves)
- Class B - Low to moderate risk devices (e.g., contact lenses, blood bags, syringes)
- Class C - Moderate to high risk devices (e.g., lung ventilators, bone fixation plates, dialysis equipment)
- Class D - Highest risk devices (e.g., heart valves, pacemakers, coronary stents, implantable defibrillators)

Classification follows GHTF/IMDRF principles based on invasiveness, duration of use, and active/non-active nature.

Registration requirements:

All medical devices must be registered with HSA before supply in Singapore:
- Class A (general) - Product listing only, no pre-market review
- Class A (sterile/measuring) - Abridged evaluation route
- Class B, C, D - Full evaluation with clinical evidence and technical documentation

Registration submissions follow the ASEAN Common Submission Dossier Template (CSDT), facilitating simultaneous submissions across ASEAN member states.

Dealer's license:

Any person or company dealing in medical devices (manufacture, import, export, supply) must hold a valid Dealer's License from HSA. Requirements include:
- Qualified person with relevant qualifications and experience
- Quality management system (QMS) implementation
- Adequate facilities and equipment
- Annual license renewal

ASEAN harmonization:

Singapore actively participates in ASEAN Medical Device harmonization through:
- ASEAN Medical Device Directive (AMDD) - Common regulatory framework
- ASEAN CSDT - Standardized submission template
- ASEAN MRA - Mutual recognition arrangements for QMS audits
- Alignment with IMDRF guidance documents

This enables manufacturers to leverage Singapore registration for other ASEAN markets and vice versa.

Quality Management Systems:

HSA recognizes ISO 13485 certification from accredited bodies. Manufacturers can demonstrate compliance through:
- Third-party QMS certification
- MDSAP audit reports
- Regulatory authority certificates (FDA, TGA, Health Canada, etc.)

Post-market surveillance:

License holders must:
- Report adverse events and field safety corrective actions
- Maintain vigilance systems for safety monitoring
- Conduct periodic safety update reports
- Implement recalls when necessary
- Maintain technical documentation and device history

Recent developments:

HSA has implemented requirements for Unique Device Identification (UDI), enhanced cybersecurity guidance for connected devices, and streamlined approval pathways for innovative technologies. Singapore's participation in the Medical Device Single Audit Program (MDSAP) facilitates international market access.