The Saudi Food and Drug Authority (SFDA) has announced a comprehensive update to its Conformity Assessment Bodies (CAB) Requirements Guide, now in its third edition. This strategic update aims to strengthen oversight and quality control, requiring both local and international establishments to adhere to precise technical specifications. This step reflects the SFDA's commitment to enhancing pre-market surveillance and ensuring the safety and efficacy of all products entering the Saudi market before they reach consumers.
Historically, the Saudi Food and Drug Authority (SFDA) was established to play a leading and pivotal role in protecting public health in the Kingdom by ensuring the safety of food, drugs, and medical devices. With the launch of Saudi Vision 2030, the SFDA has intensified its legislative and regulatory efforts to align with the highest international standards. Updating the regulations for conformity assessment bodies is an extension of this approach, as the SFDA continuously strives to close any regulatory gaps that could affect consumer health and to develop its inspection and accreditation system to be among the best regionally and globally.
In this context, the Authority's Operations Sector revealed the adoption of stringent oversight mechanisms for granting accreditation certificates to conformity assessment bodies, both within and outside the Kingdom. This rigorous procedure is based on executive regulations and board resolutions to ensure that assigned tasks are performed with the highest standards of efficiency and transparency. The Authority emphasized the obligation of inspection bodies to conduct all their inspections on-site at the premises of the targeted establishments, thus preventing any manipulation and ensuring accurate and realistic assessments.
Controls for inspection processes and quality management
The Authority emphasized the importance of immediately ceasing the issuance of certificates if an entity's activities are suspended or curtailed by the Authority or accreditation bodies. Regarding quality management systems, the new amendments stipulate the inclusion of the establishment's unified number in the commercial register and the industrial license number for factories. It also stressed the necessity of matching the trade name on the issued certificate with the approved registration number, and not merely stating the trademark. The Food and Drug Authority warned designated laboratories against failing to participate in approved proficiency tests, emphasizing that repeated violations of these requirements will subject the laboratory to strict measures in accordance with its established penalties.
Laboratory analysis procedures and technical competencies
In the context of laboratory analyses, the new guidelines require laboratories to collect two separate samples, with the second sample to be retained for 60 days if the first sample tests positive. The guidelines also stipulate that any test contested by a client must be suspended until corrective measures are completed and the authority approves its reactivation. Regarding technical staff, the updates require technical assessors to hold at least a bachelor's degree in specialized fields such as microbiology, chemistry, biomedical engineering, or pharmacy to ensure the quality of the assessment. The guidelines also indicate that a diploma is acceptable as a minimum qualification for field inspectors, provided they have completed documented training programs demonstrating competence and practical experience.
Expected impact and certificate validity period
At both the regional and international levels, this update carries significant weight. It sets stringent standards for global exporters seeking to enter the Saudi market, thereby enhancing the quality of imports. The regulations outline the process for exporting companies to the Kingdom, granting conformity assessment bodies a 60-day period to conduct inspections following approval by the Authority. The regulations stipulate that inspection reports are subject to rigorous review by the Authority to determine final accreditation or to direct companies to implement corrective action plans. The guidelines specify a one-year validity period for conformity certificates for certain products, including food additives, infant formula, energy drinks, and nutritional supplements. The amendments also expand the scope of work for conformity assessment bodies, most notably the issuance of conformity certificates for various types of tobacco shipments.
