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

Project Summary

The project scope included consulting on medical device regulation of Saudi Arabia and authoring technical file documents for submission to the Kingdom of Saudi Arabia’s electronic system for Marketing Authorization.  The medical devices in scope are monopolar devices used for cutting, grasping, dissecting and coagulation of tissue in endoscopic and laparoscopic procedures.

Challenges

  • The active and invasive medical devices are a complex laparoscopic instrument system composed of reusable and disposable components.
  • Monopolar surgical instruments use alternating current (AC) in which electrons alternate direction at the speed of light. The patient is included in the circuit, and the electrical current enters the patient’s body.
  • The devices were an older version slated for obsolescence. Testing data to current standards was not available.
  • Product was held by customs at the border awaiting marketing authorization.

Celegence Solution & Approach:

Celegence authored and/or compiled the documentation necessary to achieve marketing authorization in Saudi Arabia including:

Highlights:

  • 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.

Project Achievements

Celegence delivered the following value and business impact to the client:

  • The client received a Medical Device Marketing Authorization (MDMA) from the Saudi Food and Drug Authority (SFDA) for Class C medical devices.

  • The MDMA included 10 different model numbers comprised of reusable and sterile disposable devices that formed a laparoscopic and/or endoscopic instrument system.

  • The SFDA approval was obtained well within the stipulated timeframe.

  • Only two questions were generated during the review cycle on clarification of the submission documents.

  • Client signed a 5-year EU MDR maintenance contract.

Project Success

Celegence’s expertise enabled the client to secure Saudi MDMA approval swiftly for their Class C laparoscopic devices, overcoming regulatory complexities and ensuring full compliance with SFDA standards, underscoring Celegence’s commitment to regulatory excellence.

Get in touch today to discuss your regulatory needs by reaching out to info@celegence.com or contact us online.