The Medical Device Control Division (MDCD) of the Thai Food and Drug Administration (Thai FDA) has issued guidance clarifying the labeling and Instructions for Use (IFU) requirements for Software as a Medical Device (SaMD) marketed in Thailand.
The guidance outlines the minimum information expected on SaMD labels or IFUs and explains how the requirements may be met depending on whether the software is distributed with or without physical packaging.
Read the Thai FDA infographic here:
Thai FDA SaMD Labeling and IFU Guidance
Purpose of the Guidance
To clarify how labeling and IFU requirements apply to Software as a Medical Device distributed in Thailand.
The guidance also provides flexibility for SaMD supplied electronically by allowing required labeling information to be provided through appropriate digital formats.
Minimum Information Required
The SaMD label or IFU should include the following information:
- Product name
- Intended purpose
- Instructions for use
- Necessary medical device information
- Name of the manufacturer or product owner
- Software version, manufacturing identifier, model number, or device identifier
- Warnings, contraindications, or precautions, where applicable
- Unique Device Identification (UDI), where applicable
Labeling Requirements by Distribution Format
A. Software Without Physical Packaging
For SaMD distributed without physical packaging, such as:
- Web-based software
- Mobile applications
- Downloadable software
the required labeling information may be provided electronically.
Acceptable methods may include:
- Software interface
- Website
- Application platform
- QR code
- Downloadable IFU
Companies should ensure that users can access the required product, manufacturer, identification, use, and safety information through the applicable electronic format.
B. Software With Physical Packaging
For software supplied through physical media, such as:
- CD-ROM
- USB drive
the required labeling information must be displayed on the physical packaging.
Additional information may be provided in the accompanying IFU where necessary.
Language Requirements
Labels and IFUs may be provided in:
- Thai
- English
Additional languages may also be included, provided that the content remains consistent with the Thai or English version.
Implications to Clients
Manufacturers, license holders, and other stakeholders supplying SaMD in Thailand should review their existing labeling and IFU documentation against the Thai FDA guidance.
In particular, companies should:
- Confirm that the required product identification, intended purpose, manufacturer information, software version, and safety information are included.
- Review whether electronic labeling methods are appropriate for SaMD distributed without physical packaging.
- Ensure physical packaging contains the required information where software is supplied through CD-ROM, USB drive, or similar media.
- Check that any additional language versions remain consistent with the Thai or English labeling.
- Update labeling and IFU documentation where necessary to maintain regulatory compliance and continued market access.
Compliance Timeline
License holders must ensure compliance with the applicable labeling and IFU requirements and complete any necessary updates within 120 days following the release of the medical device for market distribution after Thai FDA review.
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Thailand, please contact sales@andamanmed.com.