Companies need to register their medical devices at the Saudi Food and Drug Authority (SFDA) before marketing in Saudi Arabia. The SFDA is the regulatory agency responsible for the safety, efficacy, and quality of medical devices. Therefore, product registration is one of the SFDA roles which is becoming more complicated with the early and heavy adaptation of the latest global standards.
The SFDA recognizes certain authorizations in other GHTF countries such as the European Union, United States, Canada, Australia, Japan, which simplifies the authorization process in Saudi Arabia. However, the last date for accepting applications through the GHTF rout is 01/01/2021. Thereafter, all applications would be accepted through TFA (Technical File assessment) route in the GHAD system. In recent months, the SFDA has revised numerous requirements in a way that is strongly influenced by the MDR and IVDR.
Table of contents
AR for Medical Devices Registration in Saudi Arabia
Medical devices in Saudi Arabia must have an authorized representative (AR) registered in SFDA. If the medical device product is Low-Risk, Non-measuring, Non-Sterile, in that case, the AR agreement is not required and the applicant(local agent) can submit directly under what is called the MDNR listing system. The validity of the approval will be for three years, which can be renewed later on. However, the renewal shall be made before (60) days of the validity expiration date of the “SFDA Medical Device National Listing Number”
SFDA Medical Devices Registration System
Until Dec 2019, the Saudi FDA has separate sites for various services, such as acquiring the Establishment License (MDEL-Medical Device Establishment License), Authorized Representative License, registration of different products to get Marketing Authorization. However, to ease that process, the Saudi FDA has launched a common online submission portal for all these services known as the GHAD System (Unified Electronic System). An applicant needs to create a user ID in this portal to avail of various medical device registration services.
Class I Medical Devices Registration
For registration of Class I Medical Device (Low-Risk, Non-Sterile, Non-Measuring Devices), the applicant must ensure that the following documents be gathered from the respective manufacturer & have them reviewed well before submitting the application to SFDA.
Requirements
- Copy of manufacturer’s Business Registration certificate
- Copy of label as affixed with the product & its wrapper
- IFU (Instruction for use)
- Declaration of conformity
- ISO 13485 or Quality Management System or internal manual of the quality procedure or other
- Marketing material/brochure (optional)
- FSC-Free sale Certificate or evidence of registration for respective jurisdiction
The above-cited documents are the standard requirements for registering Class I (Low-Risk, Non-Sterile, Non-Measuring devices). However, it is pertinent to mention here that the SFDA reviewer may ask for some additional requirements or information that must be furnished to satisfy their query.
Timelines
The time frame is 4 working days
Fees
Class I Device Fee: SAR 500 each device
Class II Medical Devices Registration
To register medium to high-risk devices in SFDA (MDMA), the applicant must ensure all documents are collated from the respective manufacturer and have them reviewed well before submission.
Execution of the AR agreement and subsequent AR license is mandatory for acquiring Medical Device Marketing Authorisation (MDMA) for medium to high-risk devices (Class II & Class III)
The following standard documents are required from the respective manufacturer to acquire Medical Device Marketing Authorisation for applying the GHAD system.
Requirements
- Product label as is affixed with the product & must meet Labelling criteria of SFDA (MDS-G10)
- Declaration of Conformity from manufacturer
- IFU-Instruction of use
- Marketing Material/Brochure
- Notified Body name with their number
- EC certificate
- Quality Management System (QMS)
- Most recent audit report with audit finding report
- Country (Saudi Arabia) specific statements (templates) from SFDA
- Environmental factor statement
- Marketing Authorisation Statement
Technical File
- Table of contents
- Clinical Evaluation Report (CER), and copies of referenced articles
- Complete Biological Evaluation Reports including all biocompatibility testing data
- Post-Market Surveillance (PMS) Plan and Report
- Post-Market Clinical Follow-up (PMCF) Plan and Report
- Risk Management File (RMF)
- Risk classification criteria/rule and rationale
- Any referenced documents within previously requested documentation.
- Besides the above-cited documents, SFDA officials may ask for any further documents or information as they deem wise.
Timelines
The time frame is 35 working Days
Fees
The SFDA fees for medical devices varies according to the Class and the number of products in each application. They are as follows:
- Class I = SAR 15,000
- Class IIa = SAR 19,000
- Class IIb = SAR 21,000
- Class III & IV = SAR 23,000
Products that meet bundling criteria can be grouped in the following groups, and the fee will be applicable accordingly:
- 1-5 Products
- Fee: SAR 30,000 (approx. $8015)
- 6-20 Products
- Fee: SAR 40,000(approx. $10,682)
- 21-50 Products
- Fee: SAR50,000(approx. $13,348)
- For any update / variation Fee: SAR 7000
The total number of medical devices grouped/bundled within a single application of MDMA shall not exceed 50 items.
License Validity
As per EC certificate expiry
Notes
- The submitted application will be returned if the fee is not paid within (30) days from the date of receiving the invoice from SFDA.
- The submitted application will be deleted and the paid fees will not be refunded when SFDA returns the application due to the applicant’s failure for not updating the application within (60) days.
- SFDA will delete submitted applications and will not return the paid fees when SFDA returns the application three times, and the applicant does not update the application without complying with the SFDA requirements and comments.
How Can We Help?
Whether you’re a new company to the Saudi Arabia market or already active commercially, we at PharmaKnowl can support you to have your products marketed in the shortest time. We ensure compliance and efficient regulatory support for our clients.
- Due diligence & Gap analysis report on product files and related entities.
- Prepare and compile technical files
- Submission & approvals
- Execute AR duties
We act as the authorized representative for companies in Saudi Arabia, providing full regulatory and supply chain support (shipment clearance). Contact us now for more information.
