Hand-Holding Through The Regulatory Maze
We work with a vetted network of Authorised Representatives across the region, manage that relationship on your behalf, and prepare your submission files before commissioning an AR, so you are guided through the process, never navigating it alone
Regulatory & Licensing: Guided Through the Process
A Partner Who Knows the Way Through
Authorised Representative Selection
- We identify and vet the right Authorised Representative for your product category and market, based on track record and fit.
AR Due Diligence
- Before any engagement, we run due diligence on prospective ARs so you are not taking that risk in the dark.
Submission Preparation
- We prepare and quality-check your submission files and documentation before they go to your AR, reducing back-and-forth and errors.
Relationship Management
- We manage the ongoing relationship with your AR throughout the process, so you always have one point of contact instead of navigating a third party alone.
Company Setup Support
- MISA licensing, virtual or physical office registration and bank account formation support, coordinated alongside your regulatory pathway.
Complex Regulation, A Partner Who Knows the Way Through
We work with a vetted network of Authorised Representatives, manage that relationship from due diligence through submission, and prepare your files before commissioning an AR — so you are guided, not guessing.
Insights & Answers
Frequently Asked Questions
-
Find answers to common questions about navigating the SFDA approval process, ensuring compliance, and expediting market entry for your healthcare products in Saudi Arabia.
01. What licenses are required to start a business in Saudi?
The exact requirements depend on your ownership structure and business activity. For most foreign companies, the process typically includes registering with the Ministry of Investment, establishing a Saudi legal entity or branch, and obtaining a Commercial Registration (CR). Certain regulated activities may also require additional sector-specific licences or approvals before you can begin trading.
WHV can help you identify the right company structure, licences and approvals for your business and guide you through the set-up process.
02. How long does it take to get SFDA approval?
For medical devices, the SFDA states that a Marketing Authorisation can be issued within up to 35 business days, provided the application is complete and all requirements are met.
In practice, the overall timeline can be longer if documentation needs to be prepared, translated, corrected or supplemented before submission. WHV can help prepare the application properly from the outset to reduce delays and manage the process through to approval.
03. What documents are needed for SFDA approval?
The exact documentation depends on the type and classification of your medical device, but typically includes technical documentation, device descriptions and specifications, evidence of safety and performance, risk management documents, quality management information, labelling and instructions for use, clinical evidence where applicable, and post-market surveillance information. The SFDA also requires manufacturers to maintain an appropriate quality management system, typically aligned with ISO 13485.
WHV can review your existing regulatory file, identify any gaps and help prepare the documentation required for your Saudi FDA application.
04. Can I sell my product in Saudi without SFDA approval?
Generally, no. If your product is regulated as a medical device, it must normally be registered with the Saudi FDA and hold valid marketing authorisation before it can be legally sold or supplied in Saudi Arabia.
WHV can help you understand your product classification, the relevant approval pathway, whether you need an authorised representative, and what is required to prepare your Saudi FDA application
05. Does SFDA approval need to be renewed?
Yes. Saudi FDA Medical Device Marketing Authorisation is issued for a limited period and must be renewed to remain valid. Under the SFDA’s medical device regulations, an authorisation can be valid for up to three years.
WHV can help you monitor renewal dates, prepare the required documentation and manage the renewal process so there is no interruption to your ability to market your product in Saudi Arabia.
Ready for Licence Support in the GCC?