REG-SOLUTIONS: Your Compliance Partner
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Regulatory Compliance: Ensure your devices meet all requirements.
Regulatory Compliance: Ensure your devices meet all requirements.
Medical Market Access: Streamline registration and approval processes.
Expertise and Guidance: Every step of the way, from planning to success.
SFDA Medical Device Registration Process in Saudi Arabia
A Technical File Assessment (TFA) is required for market authorization by the Saudi FDA, whereas the SFDA has implemented its own classification system for medical devices. Registration in the Saudi Arabia does not require prior approval in the country of origin, and approval in the reference country is not required for MDMA registration. However, proof of approval in other markets is required for registration.
SFDA Medical Device Registration Requirements
Through the SFDA's Unified Electronic System, or GHAD, all application documents are submitted electronically. The following documentation must accompany SFDA submissions in English:
1. Specifications (including accessories) of the device
Trade name (in English and Arabic if the device is intended for lay use)
Model name(s)/number(s), catalog number(s), etc. (For software, the major version number may be used for this purpose)
Device description
The intended purpose
Classification
Evidence of approval in other countries, if available
2. Labeling
Labels and packaging; power supply labels, where applicable
Instructions for use (IFU) or a justification letter, if not available
Information on storage, transportation, installation, maintenance and disposal (may refer to IFU).
Barcodes
Currently only required for lay-use devices
See the Unique Device Identification (UDI) section for information about SFDA's implementation of UDI requirements for all devices.
Proposed advertising material
For software, the SFDA generally requests an explanation of the version digits (e.g., which digit represents a significant/major change, and which digit indicates a minor change).
3. Design and manufacturing information
Bill of materials
Description of device function and assembly
Technical specifications
Manufacturing process flow
4. Essential principles checklist
Declaration of Conformity – See Annex 14 of MDS-REQ 1 for a template.
5. Analyzing and managing the benefits and risks
Procedure
Risk management plan
Risk analysis
Risk management report
6. Product verification and validation
Pre-clinical data
Clinical data
7. Post-market surveillance plan
8. In the case of Class A medical devices or Class A and B IVDs, a periodic safety update report (or post-market surveillance report) is required.
The above is an abbreviated summary of information and documents that must be included in the Technical Documentation File submitted for MDMA registration for most devices (In order to submit to the SFDA, medical devices not classified as IVDs, sterile, measuring, reusable surgical instruments, and/or novel must meet abbreviated requirements, as described in MDS-REQ 1.)
