SFDA has issued Version 2.0 of the “Guidance for Combination Products Classification and Registration,” effective 5 March 2026, introducing a clearer classification pathway, defined procedural timelines, and a phased transition toward mandatory ancillary dossier requirements by 2030.

The guidance reinforces the importance of Primary Mode of Action (PMOA) in determining the leading regulatory sector.
The updated SFDA guidance establishes regulatory principles governing the classification, designation, and registration submission requirements for combination products consisting of components subject to different regulatory frameworks.

🔍 What’s New
Confirmation that PMOA determines whether Drug or Medical Device regulation leads the review process.
Introduction of a formal classification procedure, including review within 3 working days and an appeal period of 60 working days.
Establishment of a three-phase implementation model:
Phase I (2026–2027),
Phase II (2027–2030 – voluntary ancillary dossiers),
Phase III (from 2030 – mandatory ancillary dossier submission).
Updated documentation requirements and appendices for ancillary drug dossiers and ancillary medical device requirements.
Clarification of registration pathways and indicative timelines based on the designated leading sector.

💡 Why it Matters:

The shift to mandatory ancillary dossiers by 2030 highlights the need for early portfolio and submission planning.
Companies must scientifically justify their PMOA to avoid misclassification, which can lead to significant market access delays.

📌 How ReguLinked Can Support:

PMOA Strategy: Expert determination of the leading regulatory sector. Ancillary Dossier Authoring: Preparing technical documentation for drug/device components.
Lifecycle Planning: Strategic transition management for Phase III compliance.

Planning to assess the impact of this SFDA update on your products?
Let ReguLinked support your regulatory readiness with a fully compliant strategy.

“Book your complimentary consultation today”

📧 bd@regulinked.com | 🌐 www.regulinked.com

📎 Official Source: Guidance for Combination Products Classification-En

#ReguLinked #SFDA #SaudiArabia #CombinationProducts #MedicalDevices #Pharmaceuticals #MarketAccess #RegulatoryAffairs