Draft Guidance Open for Comment
Live tracking
This page lists SFDA guidance documents currently open for public or industry consultation. Check the SFDA website for the current status of consultations, as comment periods open and close regularly.
How the SFDA consults on guidance
The SFDA publishes draft guidance documents for industry comment before finalisation. Participation in consultations allows manufacturers and ARs to:
- Influence how requirements are interpreted and applied
- Flag practical implementation challenges
- Clarify ambiguous requirements before they become binding
How to participate
Draft guidance documents are published on the SFDA website under Medical Devices → Regulations and Guidance → Draft Documents (or equivalent section). Comment submission methods vary but typically include:
- Online comment form on the SFDA website
- Email submission to designated SFDA contact
- Industry association consolidated responses
Current open consultations
Check the SFDA website for currently open consultations. This page will be updated as consultations open and close.
Historical consultations
The SFDA periodically consults on:
- New MDS-REQ or MDS-G documents
- Updates to existing MDS-REQ requirements
- UDI implementation guidance updates
- Digital health and SaMD frameworks
- Alignment with new IMDRF guidance