Thailand's Food and Drug Administration (TFDA) has issued guidelines on May 9, 2024 for registration of software (SaMD) to determine whether SaMD software is suitable as a medical device.
The guidelines for Software as a Medical Device (SaMD) registration are briefly as follows.
< Type of medical device software >
- Embedded Software: Software embedded in medical devices
- Standalone Software: Standalone software including mobile applications
- Software Accessories: Supplementary tools used in conjunction with medical equipment
- Non-Medical Device Software: Software that is not used for medical purposes
<Documents submitted by SaMD according to risk classification>
1. Class I
- Medical Device Label
- Documents accompanying medical devices: labels and related documents
- Details of Medical Devices: Specification, general characteristics, working principles etc.
- Power of Attorney
- Certificate (Declaration) of Conformity
- Overseas Product Registration Document (Certificate)
2. Class II, III
- Medical Device Label
- Documents accompanying medical devices: labels and related documents
- Details of Medical Devices: Specification, general characteristics, working principles, indications, warnings etc.
- Essential Principle
- Summary Verification & Validation
- Risk Management Document
- Manufacturing Information
- Certificate of ISO/GMP Production Quality System
- Certificate (Declaration) of Conformity
- Certificate of Sales History
- Power of Attorney
- Certificate (Declaration) of Conformity
- Overseas Product Registration Document (Certificate)
The submission documents differ according to the risk classification, and please refer to the link below for more information.