SaMD, Borderline & Combination Products
Software as a Medical Device (SaMD)
SaMD with a medical intended purpose is regulated as a medical device under NMRA's framework. Classification uses standard classification rules applied to the software's clinical function and risk.
Key Documentation for SaMD Registration
| Document | Requirement |
|---|---|
| IEC 62304 software lifecycle | Expected |
| IEC 62366-1 usability engineering | Expected |
| ISO 14971 risk management (software hazards) | Required |
| Algorithm validation (AI/ML) | Required where applicable |
| Cybersecurity risk assessment | Expected |
| ISO 13485 certificate covering software development | Required |
AI/ML Considerations
For SaMD using AI/ML algorithms:
- Document the training data, validation methodology, and performance metrics
- Define the learning boundary — changes beyond the pre-approved scope trigger a change notification
- Plan for post-market monitoring of algorithm performance in real-world use
Borderline Products
Device vs pharmaceutical: The principal mechanism of action determines the regulatory pathway:
- Physical/mechanical action principal → medical device (NMRA)
- Pharmacological/biological action principal → pharmaceutical (drug regulation)
When both actions are present, the product is classified based on which component provides the primary intended purpose.
Common Borderline Examples
- Wound dressings with antimicrobial agents: The wound management function is principal → medical device
- Devices incorporating hormones: May be pharmaceutical depending on the hormone's role
- Contrast agents: Pharmaceutical
- Drug-eluting stents: Borderline — typically classified as medical device in international markets
Always seek NMRA determination for borderline products before committing to a regulatory strategy.
Combination Products
A product combining a device and a medicinal component is classified based on the principal intended action component. Document:
- The function of each component
- Why one component is principal
- The regulatory precedent in reference countries
Radiation-Emitting Devices — LK-Unique Dual Pathway
Medical devices that emit radiation — X-ray, radiation therapy, nuclear medicine, dental X-ray — require two separate approvals:
- NMRA — standard Registration Certificate and Import Licence
- Atomic Energy Authority (AEA) of Sri Lanka — under the Atomic Energy Authority Act
Both approvals must be held before market supply. Start both processes in parallel. See Radiation-Emitting Devices for detailed guidance.