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MDMA-2 — Technical File Assessment (TFA)

What is the TFA route?​

The Technical File Assessment (TFA) route — also called MDMA-2 — has been the only MDMA registration pathway in Saudi Arabia since January 2022. It requires manufacturers (via their AR) to submit a complete technical dossier for every device, regardless of risk class.

Why TFA replaced the GHTF route​

Before 2022, the SFDA offered two routes:

  • MDMA-1 (GHTF route) — accepted reference country approvals (EU, US, Canada, Japan, Australia) without requiring full technical files; cancelled end of 2021
  • MDMA-2 (TFA) — required a complete technical file and independent SFDA evaluation

The SFDA discontinued MDMA-1 to conduct independent, risk-based evaluations of all devices entering the Saudi market, aligned with its IMDRF membership commitments.

Existing MDMA-1 certificates

Devices registered under the GHTF route retain their MDMA certificates until expiry. Renewals for MDMA-1 certificates must now follow the TFA pathway — a full technical file is required at renewal, even for devices originally registered under GHTF.

TFA technical file structure (MDS-REQ 1 Annex 3)​

The SFDA requires the technical file to follow a structured format. Key sections include:

  1. Device description and intended use — name, models, catalogue numbers, intended purpose, patient population, indications, contraindications
  2. Manufacturer information — legal manufacturer details, manufacturing sites
  3. Essential Principles compliance — how each applicable principle is addressed (with reference to test standards)
  4. Risk management — ISO 14971 risk management report
  5. Design and manufacturing — technical drawings, specifications, manufacturing process description
  6. Performance and safety testing — test reports and certificates (biocompatibility, sterility, EMC, electrical safety, etc.)
  7. Clinical evaluation — CER or equivalent clinical evidence summary
  8. Labelling and IFU — all label artwork, IFU (English; Arabic for home-use devices)
  9. Post-market surveillance plan
  10. Declaration of Conformity — signed using Annex 14 template
  11. Annex-specific items — sterility validation, measuring function verification, reusable device cleaning validation as applicable

What the SFDA checks first​

The initial SFDA submission check (step 4 in the MDMA process) is a completeness check only — not a content review. The SFDA verifies that all required sections are present and that the application format complies with GHAD requirements. Incomplete submissions are rejected at this stage.

Queries and deficiency letters​

During technical review, the SFDA may issue one or more query letters via GHAD requesting clarifications or additional data. The manufacturer (via AR) must respond within the timeframe specified. Delayed or inadequate responses are a common cause of extended review timelines.

Further reading​