Achieving Saudi Arabia Medical Device Marketing Authorization (MDMA) with Precision and Efficiency

Medical Device Classification and rationale; Class C active and invasive determined by following the classification rules and definitions in SFDA Guidance Document MDS-G008 Guidance on Medical Devices Classification.

Authoring and assembly of a Technical File meeting Saudi Arabia Article Eight, Nine and Ten of the “Medical Devices Law” issued by the Royal Decree No. (M/54) dated 6/7/1442 H and “Implementing Regulation of Medical Devices Law” issued by Saudi Food and Drug Authority Board of Directors decree No. (3-29-1443) dated 19/2/1443H.

Authoring the Essential Principles of Safety and Performance Checklist including a review of Standards and the output evidence documents.

Remediation/Drafting of documents to meet SFDA submission requirements as needed including justifications for waiving testing.

Creation of 18 technical file subdocuments for submission by the Authorized Representative to the Kingdom of Saudi Arabia’s (KSA’s) Unified Electronic System (GHAD) for Medical Device Marketing Authorization (MDMA).

A professionally published PDF with table of contents, hyperlinks, and appendixes.