Introduction: New regulations to ensure the quality of imports
In a strategic move aimed at strengthening oversight of products entering the Saudi market, the Saudi Food and Drug Authority (SFDA) announced comprehensive regulatory updates. These measures are based on Article 22 of the SFDA Law, issued by Royal Decree, and aim to establish precise controls and requirements for licensing private laboratories and conformity assessment offices. The SFDA has set a strict timeframe of a maximum of 60 working days for conformity assessment bodies to complete all inspections of facilities seeking to export to the Kingdom, starting from the date the body receives approval.
Historical context and the importance of import control
Historically, the Saudi Food and Drug Authority (SFDA) has played a pivotal role in safeguarding public health in the Kingdom through rigorous oversight of food, drugs, and medical devices. With the Kingdom's economic expansion and trade liberalization under the Vision 2030 objectives, updating regulations to keep pace with the growing volume of international trade has become essential. These updates are not arbitrary; rather, they are a continuation of ongoing efforts aimed at preventing the entry of any products that do not conform to Saudi and international standards, thus ensuring consumer safety and protecting local markets.
Strict field inspection procedures
The new amendments emphasize the obligation of conformity assessment bodies issuing certifications to conduct all inspections "on-site" at the issuing facility's premises, rejecting any leniency or exceptions in this sensitive oversight procedure. The Authority warned against any violations, stipulating the immediate cessation of certification in the event of the suspension, reduction, or cancellation of the activity of the body designated by the Authority or the accreditation body. The updates also clarified the necessity of immediately notifying the Authority of any changes to the data of the conformity assessment body or the certified facility, to ensure continued reliability and the most accurate updating of records.
Quality standards and accredited laboratories
The updated regulations emphasize the necessity of including the unified number "700" and the industrial license number in quality management system certificates, along with the accurate matching of the trade name and not relying solely on the trademark. On the laboratory side, the Authority introduced "professional proficiency testing" programs to evaluate laboratory performance and compare results with approved statistical methodologies in accordance with the requirements of the international standard ISO 17043/IEC. If a laboratory receives an "unsatisfactory" result, it is obligated to submit a root cause analysis and implement a corrective action plan within a specified timeframe. The instructions also stipulate that the designated laboratory must retain sample "B" for 60 days if sample "A" is positive, to ensure transparency and provide a secure pathway in the event of a client appeal.
Technical expertise and expanding the scope of oversight
Regarding technical staff, the Authority stipulated specific academic qualifications, including a minimum of a bachelor's degree for technical evaluation work, and a diploma for field inspection duties in specific scientific and engineering disciplines such as microbiology, analytical chemistry, pharmacy, biomedical engineering, and nuclear physics. Furthermore, the Authority expanded the scope of appointments to include issuing conformity certificates for shipments of tobacco products such as cigarettes, shisha, and e-liquids, in addition to sensitive food products such as energy drinks, nutritional supplements, and infant formula.
Expected impact locally and internationally
Domestically, this decision enhances Saudi consumer confidence in imported products and protects markets from substandard goods. Regionally and internationally, this move sends a clear message to global companies and manufacturers that the Saudi market demands the highest standards of quality and compliance. The regulations also require conformity assessment bodies to provide the Authority with compliance reports, including reports on food factories that were denied HACCP and ISO/IEC 22000 certifications, to track and monitor non-compliant facilities. All inspection reports are subject to final technical review and audit by Authority specialists to determine final approval or rejection.
