Saudi Arabia Enforcement Program for Medical Devices
The Saudi Food and Drugs Authority (SFDA) is to start the Medical Device Marketing Authorization (MDMA) Enforcement Project that will enforce the closure of ports to all medical devices (including in vitro diagnostic and active implantable devices) that do not have or have not applied for a MDMA Licence.
The SFDA and local regulations have specified for several years that all medical devices supplied to the Kingdom of Saudi Arabia must have a MDMA license. Exceptions have been made during the initial part of the regulation on the market to provide time for manufacturers to address the requirements.
As the next step in the regulation of Medical Devices, the SFDA is initiating a phased implementation of enforcement by closing the ports to products without a MDMA license or a MDMA license application in progress. The initial phase will start in October 2012 with High Risk in vitro diagnostic medical devices(IVD). In the next phases this will be extended to medium risk IVDs and high risk medical devices.
This means that from 1 October 2012, any High Risk IVD supplied to the Kingdom of Saudi Arabia must have a MDMA licence or have initiated the MDMA licence process (i.e. paid and applied for the licence which includes the submission of relevant documentation). Otherwise, it will not be permitted entry into the kingdom.
The enforcement program will then be in phases over time to cover all types of medical devices.
All manufacturers who supply medical devices of all types into the Kingdom of Saudi Arabia need to be aware of this development and to take appropriate steps to ensure they have a MDMA licence or have applied for a licence for their products requiring entry into the Saudi Arabian Market. Although the SFDA has ensured adequate resources for reviewing applications, it is still recommended that manufacturers do not delay their applications.
The SFDA has implemented a range of Regulations and Guidance documents for the regulation of Medical Devices within the Kingdom of Saudi Arabia.
These documents can be found on the SFDA Website
Main Features of SFDA Regulations
All medical devices supplied into the Kingdom of Saudi Arabia must already meet the requirements of one of the GHTF Member States i.e. EU, US, Canada, Australia and Japan.
In addition to the product being registered in one of the member states there are additional requirements designated by the SFDA in relation to local Environmental conditions, power supply, etc. as defined in the SFDA Implementation Rules.
The SFDA works with five Conformity Assessment Bodies, of which SGS is one, in the review of applications for the MDMA license but all communications go through the SFDA.
All applications for licenses must go through a licensed Authorized Representative in the Kingdom of Saudi Arabia.