How to Secure a License to Establish and Import Medical Devices in Saudi Arabia
Licensing Requirements Under Saudi Medical Device Regulations
Article 15 of the Implementing Regulations on Medical Devices and Products—issued by the Board of Directors of the Saudi Food and Drug Authority (SFDA) on 29/12/1429H—requires importers and distributors of medical devices to obtain licensing for their facilities, branches, and warehouses from the SFDA. In this article, Salamah Law Firm outlines the legal requirements for investors seeking to obtain establishment and import licenses for medical devices in Saudi Arabia.
What Is a Medical Device Establishment License in Saudi Arabia?
According to the Medical Devices and Supplies Law (1442H), a medical device is defined broadly as:
“Any instrument, apparatus, appliance, implant, in vitro reagent, calibrator, software, or related item, whether used alone or in combination, intended by the manufacturer to be used for human diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury, life support, or to assist in conception, sterilization, or medical information purposes derived from human samples. Devices do not achieve their primary intended action in/on the human body through pharmacological, immunological, or metabolic means.”
Article 2 of the law specifies that the regulation applies to the design, manufacture, import, marketing, distribution, and storage of such devices.
Legal Prohibition on Practicing Without a License
Article 6 clearly states:
“No establishment may engage in any regulated activities without proper registration, licensing, and—if a manufacturing facility—an industrial license from the competent authority.”
Steps to Obtain a Medical Device Establishment License
To secure a new license for importing and distributing medical devices and products, investors must:
- Open an account on the SFDA’s unified electronic platform (GHAD) to obtain a company account number.
- Register on the GHAD platform to apply for a license to conduct import and distribution activities.
- Upon approval, pay the licensing fees. The license is granted only after implementing and documenting a Quality Management System (QMS) compliant with ISO 13485:2016 (GSO/SFDA equivalent).
- Undergo an on-site inspection by SFDA officers.
Conditions for Importing Medical Devices in Saudi Arabia
To obtain an import license for medical devices, the applicant must provide:
- A valid company account number issued by the SFDA.
- A list of the medical devices/products to be imported, including detailed information about their manufacturers.
- A declaration that the company possesses all documents confirming compliance with Article 16 of the Implementing Regulations, including:
- Notifying the manufacturer or legal representative before marketing restricted devices in Saudi Arabia.
- Ensuring proper storage and transport per manufacturer’s recommendations.
- Maintaining traceable sales documentation and assuming market surveillance responsibilities.
- Confirming all marketing authorizations and product labeling are in place, and notifying SFDA if not.
- Informing the SFDA of any data changes within 10 days.
- A commercial registration indicating activity in medical device trade (from the Ministry of Commerce).
- Valid municipality and Civil Defense licenses.
- Payment of licensing fees based on facility category:
- Category A: SAR 25,000
- Category B: SAR 15,000
- Category C: SAR 8,000
- Category D: SAR 5,000
(Payable via SADAD using SFDA biller code: 109)
- Implement and document a Quality Management System (QMS) in line with ISO 13485:2016.
Read Also : How Can an Investor Obtain a License to Establish a Medical Complex in Saudi Arabia??
Requirements for Setting Up a Medical Device Business in Saudi Arabia
Investors must submit the following documents:
- A statement from GOSI (General Organization for Social Insurance) or a Ministry of Labor company account printout indicating the number of employees working in the medical field.
- A detailed digital site plan of the facility’s proposed location, showing nearby landmarks, city, district, street names, and contact information, including coordinates.
- Copies of municipality and Civil Defense licenses.
What Are the Costs for Registering Medical Devices in Saudi Arabia?
Registration costs vary depending on the type and classification of the device by the SFDA.
SFDA’s Medical Device Import Authorization System
The SFDA offers a dedicated service for issuing import permits for medical and laboratory devices for the following purposes:
- Research or education
- Exhibitions or training
- Public health emergencies
- Custom-made devices
- Clinical trials
- Personal use
It also covers import of therapeutic biological products and non-medical lab reagents subject to Ministry of Interior controls, as well as international proficiency test samples.
Conditions for Opening a Medical Device Trade License (CR)
To obtain a commercial registration (CR) for importing and distributing medical devices, one must first secure the SFDA license as described above, then apply through the Ministry of Commerce.
What Is the Penalty for Importing Without a License?
Article 41(3) of the Medical Devices Law considers it a violation to:
“Import or attempt to import into the Kingdom any unregistered, falsified, or unauthorized medical device or product.”
Article 42(2) sets forth the penalties:
- Imprisonment up to 10 years
- Fines up to SAR 10 million
- Or both, in addition to possible penalties such as:
- Temporary facility closure (up to 180 days)
- Suspension or cancellation of marketing authorization
- Ban on engaging in device-related activities for up to 180 days
- Full license revocation
- Double penalties for repeat offenses
In Conclusion:
Obtaining licenses to establish and import medical devices in Saudi Arabia is a complex legal and regulatory process. It requires a deep understanding of legal, administrative, and technical regulations in the healthcare sector. For this reason, investors are strongly advised to consult with Salamah Law Firm, which brings over a decade of experience in:
- Securing healthcare licenses
- Providing precise legal guidance
- Representing clients before judicial and regulatory authorities
Our goal is to safeguard your rights and ensure full compliance with Saudi health regulations.
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