SaMD, Combination Products & Special Classifications
Software as a Medical Device (SaMD)
Software with a medical intended purpose is included in Thailand's medical device definition and must be classified using the standard Class 1–4 rules based on the software's clinical function and risk.
SaMD Classification Principles
- What is the severity of the health condition the software addresses?
- Is the software's output used to drive clinical decisions directly, or only to inform?
- What is the consequence if the software's output is incorrect?
High-severity condition + software directly drives treatment → Class 3 or 4 Low-severity + informational output → Class 1 or 2
SaMD Documentation
| Document | Requirement |
|---|---|
| IEC 62304 software lifecycle | Required |
| IEC 62366-1 usability engineering | Required |
| ISO 14971 risk management (software hazards) | Required |
| Algorithm validation (AI/ML) | Required where applicable |
| Cybersecurity documentation | Expected |
| ISO 13485 certificate including software development scope | Required |
Combination Products — Drug-Device
Products combining a device with a pharmaceutical component are classified based on the principal intended action:
- Principal action = device/physical mechanism → regulated as medical device (Thai FDA/MDCD)
- Principal action = pharmacological mechanism → regulated as pharmaceutical (Thai FDA Drugs division)
If the boundary is unclear, seek a formal classification determination from the Thai FDA before proceeding. Filing under the wrong category can invalidate the entire registration strategy.
Drug-eluting stents: Typically classified as medical devices internationally — confirm with MDCD. Contrast agents: Classified as pharmaceuticals.
Wireless, Bluetooth, Wi-Fi Devices — NBTC Review — TH-Unique
Medical devices incorporating wireless communications technology (Wi-Fi, Bluetooth, cellular, RFID, Zigbee, or any radio frequency communication) require two separate approvals:
- Thai FDA / MDCD — standard Listing/Notification/License pathway
- NBTC (National Broadcasting and Telecommunications Commission) — approval for the radio frequency spectrum/communications aspect
Both approvals must be obtained before the device can be placed on the Thai market. The processes are independent.
Affected devices include:
- Wireless patient monitoring systems
- Bluetooth-enabled devices (glucose meters, insulin pumps)
- Remote monitoring devices (home health, IoT medical)
- Wi-Fi enabled medical imaging equipment
- Any device with a built-in cellular or satellite communication module
Practical approach: Begin both processes in parallel. NBTC's process timeline differs from Thai FDA's — starting both simultaneously minimises total time to market.
NBTC website: www.nbtc.go.th
Active Implantable Devices
Active implantable devices (pacemakers, ICDs, cochlear implants, neurostimulators, spinal cord stimulators) are typically Class 4 requiring the License pathway with the most comprehensive dossier.
Custom-Made Devices
Devices manufactured for a specific individual patient under a clinician's written prescription may be eligible for an exemption from standard Thai FDA registration. Contact the MDCD for current guidance on custom-made device requirements.
Single-Use Devices
Must be clearly labelled as single-use. Thai FDA has requirements for single-use device labelling and restrictions on reprocessing.
Export-Only Devices
Devices manufactured in Thailand for export only (not for domestic market placement) follow a separate registration pathway. Contact the MDCD for current requirements.
Thai FDA Guidance: When the principal action is unclear, manufacturers may request a pre-submission meeting with the MDCD to obtain a written determination before proceeding with full application preparation. This formal clarification is strongly recommended for combination products to avoid rejection or reclassification during review.
Custom-Made Devices Exemption: Devices manufactured for a specific individual patient on a clinician's written prescription may be exempt from standard Thai FDA registration. To qualify: (1) the device must be uniquely designed for that patient, (2) a written prescription from a licensed clinician must be on file, (3) manufacturing must be documented with traceability. Contact the MDCD for a formal exemption determination and documentation requirements. This exemption does not apply to devices manufactured in batches for potential future use.