Saudi Food & Drug Authority (SFDA)
The Saudi Food and Drug Authority (SFDA) is an independent body corporate that directly reports to The President of Council of Ministers, and its main objectives are to ensure safety of food, drug for human and animal, medical devices, and the safety of biological and chemical substance as well as electronic devices that are related to human health.
The main purpose
of the SFDA establishment is to regulate, oversee, and monitor food, drug,
medical devices, as well as to set mandatory standard specifications thereof,
whether the products are imported to the country or locally manufactured.
The authority is responsible for monitoring and/or testing activities in the
SFDA or other agency’s laboratories. Moreover, the Saudi FDA oversees
consumer’s awareness on all matters related to food, drug and medical devices
and all other products and supplies.
Registration and Approval of Medical Devices & IVD products in Saudi Arabia (KSA)
Medical Device manufacturers who wish to place their medical devices and IVD products in the Saudi market must first get the Medical Device Marketing Authorization (MDMA) approval from the Saudi Food & Drug Authority ‘’SFDA’’ through their Saudi ‘’Authorized Representative’’ to be able to ship, sell or distribute those products.
Appointing the AR ‘’Authorized Representative’’ for Medical Device & IVD product Registration
For the manufacturers located outside the Kingdom of Saudi Arabia (KSA) that wish to register their products with the Saudi Food and Drug Authority (SFDA), they must assign an AR ‘’Authorized Representative’’ to work on their behalf when dealing with SFDA for anything related to the medical devices, IVD products registration and post-marketing services, beside communication with SFDA for any questions or inquiries.
Manufacturers have two options when appointing an ‘’Authorized Representative’’:
1. AR Agreement between a Legal Manufacturer (Single Site) and the Authorized Representative.
2. AR Agreement between a Legal Manufacturer with multiple subsites and the Authorized Representative.
It is important for the legal manufacturers to legalize the AR agreement from the following authorities:
§ Chamber of Commerce in foreign country.
§ The Ministry of Foreign Affairs in foreign country.
§ The Saudi embassy in the foreign country.
Once the manufacturer appoints an AR ‘’Authorized Representative’’ they will receive the ARL ‘’Authorized Representative License’’ issued by the SFDA, which means that the Manufacturer is officially registered and listed in the Saudi FDA ‘’GHAD’’ portal under the AR account and can start the product registration process.
§ Validity of the AR agreement between the legal manufacturer and Authorized Representative can be for 5 years
§ Validity of the ARL “Authorized Representative License” is 1 year and is renewable on annual basis by the AR to legally represent the manufacturer in KSA. The Authorized Representative is the responsible party for submitting applications to the SFDA to register any medical devices/ IVD products related to the manufacturer
What is required for submitting medical device or IVD product registration application?
With the new global Medical Device Regulations MDR/IVDR updates and changes, SFDA updated their Medical Devices registration system by implementing new Regulations to assure safety and high performance of the devices, and to cope with the new global challenges and changes.
Manufacturers are required to have the ‘’Technical File’’ related to the products they want to register prepared including all the information needed in accordance with the new SFDA registration guidance MDS-REQ 1.
The MDS-REQ 1 registration guidance, has been issued on 19/12/21 where SFDA started the implementation of the Technical File Assessment ‘’TFA’’ registration route officially as the only way to follow for the medical device and IVD product registration.
Submitting applications to the SFDA
§ All application documents are submitted via the Saudi FDA MDMA system (GHAD Portal). All technical documents must be provided in English, and for products intended to be used by lay person some documents must be in English and Arabic language.
§ Thirty-five (35) working days is the official allotted timeframe for reviewing applications by SFDA.
§ Once the SFDA requirements are fulfilled, the manufacturer will receive the Medical Device Marketing Authorization (MDMA) certificate, which will be valid maximum for 3 years from the date of approval or less depending on the expiry date of the products quality certificates submitted in the application.
Medical Regulations gate (MRG) in KSA
At MRG, we always ensure that we are up to date with all Medical Devices and IVD products regulations. Therefore, MRG provides its customers and clients with all the support needed for the manufacturers to be able to easily and swiftly register their medical devices and IVD products with SFDA following the recent changes implemented by SFDA with regards to the Technical File Assessment. MRG staff is highly capable of assisting manufacturers with the preparation of the technical file required by SFDA to obtain approval for their products. In addition, MRG provides the following services:
For Overseas manufactures:
- Reviewing and submitting the AR Agreement to SFDA.
- Consultation about the Medical Devices registrations with Saudi FDA.
- Communicating with the manufacturers regulatory affairs team to help them with the TFA requirements preparation.
- Revision of the TF ‘’Technical File’’ documentation and providing feedback when necessary.
- Submitting TFA applications to Saudi FDA to obtain the MDMA certificate approval.
- Communicating with SFDA on an elevated level to discuss any issues related to submitted Technical File, to reach the best possible solutions to obtain the products approval.
- Communicating with SFDA for any Clarification, Request or Inquiry needed from the manufacturer side related to product registration process.
- Submitting renewal requests for any expired MDMA certificate for manufacturers.
- Updating any valid MDMA certificate for the manufacturers.
- Post Market follow up services for Recalls/FSCA/Adverse Events, and submission of reports to the National Centre for Medical Device Reporting ‘’NCMDR’’.
- Submitting classification requests to the classification department at SFDA for them to decide whether the product falls under the SFDA supervision or not.
- Transferring MDMA certificates from other ARs to MRG account, when requested by the manufacturer.
- Applying for Medical Devices Advertising approval
- Submission of UDI information in the Saudi-DI database for all the products that have MDMA approval.
For Local companies:
- Obtaining Medical Device Establishment License (MDEL)
- Preparing SOPs ‘’Standard Operating Procedures’’ for submission of Medical Device Establishment Licence (MDEL)
- Applying for Medical Device Importation Licence (MDIL)
- Applying for warehouse certificate with SFDA
- Working on behalf of local companies to help them with SFDA product registration under their account.
- Submitting renewal requests for any expired MDMA certificate.
- Updating any valid MDMA certificate.