Regulations for inspecting export facilities to the Kingdom within 60 days
In a decisive regulatory step aimed at enhancing the safety of imported products, the Saudi Food and Drug Authority (SFDA) announced a 60-day deadline for conformity assessment bodies to complete inspections of export facilities to the Kingdom. This decision reflects the SFDA's commitment to expediting regulatory procedures without compromising the high quality standards that ensure consumer safety.
The historical context of the role of food and medicine in protecting markets
The Saudi Food and Drug Authority (SFDA) was established with the primary objective of ensuring food safety, drug safety, and the efficacy of medical devices. Over the years, the SFDA has continuously developed its regulations to keep pace with global developments in international trade. These recent updates are part of the goals of Saudi Vision 2030, which aims to achieve the highest levels of food and drug security and transform the Kingdom into a leading global model in applying stringent standards to all imports, thereby enhancing consumer confidence in the market.
Strict procedures for inspecting export facilities to the Kingdom
The Authority clarified that this regulatory move is based on Article 22 of its bylaws, issued by Royal Decree, which aims to establish precise controls and requirements for licensing private laboratories and conformity assessment offices. The new amendments emphasize the obligation of conformity assessment bodies issuing certifications to conduct all inspections "on-site" at the facility's premises, rejecting any leniency or exceptions in this oversight procedure. The Authority warned against violations, stipulating the immediate cessation of certification in the event of the suspension, reduction, or cancellation of the activity of the entity designated by the Authority or the accreditation body. The updates also stipulated the necessity of immediately notifying the Saudi Food and Drug Authority (SFDA) of any changes to the data of the conformity assessment body or the certified facility, to ensure continued reliability and the updating of records.
Technical and laboratory competence to ensure quality
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 precise matching of the trade name and not relying solely on the trademark. The Authority also addressed the laboratory aspect, introducing "technical 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. It noted that 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 further 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 should a client appeal be accepted. Regarding technical personnel, the Authority requires 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.
Expanding the scope of oversight and the expected impact of the decision
The Authority expanded its scope of appointment to include issuing conformity certificates for all types of tobacco products, such as cigarettes, shisha tobacco, and e-liquids, in addition to sensitive food products like energy drinks, nutritional supplements, and infant formula. 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, in order to track non-compliant facilities and strengthen oversight.
This event is of paramount importance and is expected to have a significant impact on several levels. Locally, it ensures the availability of safe and high-quality products for citizens and residents. Regionally and internationally, it sends a clear message to global companies and factories that the Saudi market adheres to uncompromising standards, compelling exporters to raise the quality of their products to meet these requirements. The Saudi Food and Drug Authority (SFDA) has set a strict 60-day timeframe for conformity assessment bodies to complete inspections of facilities wishing to export to the Kingdom, starting from the date the body receives approval. The SFDA emphasized that all submitted inspection reports are subject to final technical review and audit by its specialists, who will then make a final decision on approval, rejection, or directive to complete the corrective action plan.
