Saudi FDA ensures that medical devices used in the Kingdom of Saudi Arabia meet high standards of safety and quality in today's evolving healthcare landscape. In order to simplify this process, SFDA has established comprehensive licensing requirements for medical device establishments, as outlined in MDS-REQ-009. Manufacturers, importers, distributors, and service providers in the medical devices sector are subject to these regulations.
SFDA licensing requirements apply to a wide range of entities involved in the medical device industry, including:
• Manufacturers
• Authorized Representatives (AR)
• Importers and Distributors
• Warehouses
• Clinical Trials Verification Establishments
• Service Providers such as those offering conformity assessments, testing, and quality assurance services.
The following general requirements must be met by medical devices establishments in order to obtain a license:
1. Legal Entity: Each establishment must either be a legal entity or part of one, in compliance with KSA regulations.
2. Quality Management: All manufacturers, importers, and distributors must have a Quality Management System (QMS) accredited by an SFDA-recognized body, in accordance with ISO 13485 standards.
3. Registration: Every establishment must register in the "GHAD" system to obtain a unique establishment number, crucial for licensing procedures.
4. Document Submission: All documents must be submitted through the SFDA’s electronic platform, and licenses must be renewed periodically.
5. Marketing Authorization: No medical devices are to be sold or distributed in Saudi Arabia without marketing authorization from SFDA.
The following are general guidelines, as well as specific requirements for each type of establishment:
• Authorized Representatives: Must maintain a physical presence in Saudi Arabia.
• Importers and Distributors: Must appoint a qualified person to liaise with the SFDA and comply with traceability and post-market surveillance requirements.
• Warehouses: Must ensure proper storage conditions as per SFDA guidelines.
• Clinical Trials Verification Establishments: Must employ qualified personnel and comply with strict verification and reporting guidelines.
Post-market surveillance is one of the most important aspects of the SFDA's oversight function. Medical device companies must report safety incidents and cooperate with the SFDA regarding corrective actions. The SFDA requires that safety alerts be reported, distribution data be provided, and safety measures be implemented as required.
In the event of noncompliance with SFDA regulations, a license may be suspended, revoked, or penalized. To ensure ongoing compliance, establishments should maintain transparency and work closely with the SFDA.
Conclusion
A stringent licensing requirement of the SFDA ensures that Saudi Arabian citizens have access to medical devices that are safe, efficacious, and high-quality. Manufacturers, distributors, and service providers are required to adhere to these standards by the SFDA, in order to protect public health and foster trust in the Kingdom's medical device industry.
In order for Saudi Arabian medical device companies to operate smoothly, it is essential to remain knowledgeable about SFDA's latest guidelines and maintain compliance.
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