Medical Device Marketing Authorization (MDMA)

Requirements

To obtain Medical Device Marketing Authorization in compliance with SFDA regulations, manufacturers must adhere to the following key requirements:

▪ Quality and Safety Compliance with SFDA regulations.
▪ Submit Technical Documentation for Medical Device and/or IVD Medical Device.
▪ Foreign manufacturers must appoint an Authorized Representative within Saudi Arabia who will be responsible for regulatory matters through the GHAD System – Licensing Services.
▪ Local Manufactures: License of medical devices manufacture through the GHAD System – Licensing Services.
▪ For low-risk medical devices, excluding In Vitro Diagnostics, sterile products, those with measuring functions, reusable surgical instruments, and novel devices, the submission requirements following the “Technical Documentation” are as follows:
– Detailed Device Description and Specifications
– Manufacturer’s Obligatory Information
– Checklist of Essential Principles
– Proof of Compliance with Relevant Essential Principles
– Risk Management File
– Post-Market Surveillance