New regulations for the work of conformity assessment bodies locally and internationally
The Saudi Food and Drug Authority (SFDA) has announced the release of the third update to its Conformity Assessment Bodies, a strategic step aimed at strengthening oversight and quality control at both the local and international levels. This update mandates that establishments adhere to precise technical requirements, enhancing control levels and ensuring the safety and security of products entering the Saudi market, which will positively impact consumer health.
Historical context of the development of quality standards in the Kingdom
The Saudi Food and Drug Authority (SFDA) was established with the primary objective of protecting society through effective legislation and a robust regulatory framework. Over the years, the SFDA has continuously updated its regulations to keep pace with the rapid global changes in the food and drug sectors. The third edition of the Conformity Assessment Bodies Appointment Guide represents an extension of the Kingdom's efforts to achieve the goals of Vision 2030, which prioritizes quality of life and consumer protection. The shift from traditional inspection to rigorous regulatory mechanisms for granting appointment certificates reflects the institutional maturity the SFDA has attained in managing risks related to both imported and locally produced products.
Economic and health dimensions of regulating conformity assessment bodies
This update has significant implications that extend beyond local boundaries to encompass regional and international spheres. Locally, the implementation of these regulations ensures a safe consumer environment, free from substandard or counterfeit products, thereby enhancing consumer and resident confidence in the markets. Internationally, requiring exporters and global conformity assessment bodies to comply with these stringent Saudi standards reinforces the Kingdom's position as a leading economic power that does not compromise on quality standards. This approach compels global companies to raise the quality of their products destined for the Middle East region, creating a positive ripple effect on the quality of international trade.
Strict field inspection and monitoring mechanisms
The Authority's Operations Sector revealed the adoption of stringent oversight mechanisms based on executive regulations and board resolutions to ensure tasks are performed with the highest standards of efficiency. The Authority emphasized the obligation of inspection bodies to conduct all inspections on-site at the premises of the targeted establishments. It also highlighted 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, along with the requirement that the trade name on the issued certificate matches the approved register and not merely the trademark.
Laboratory analysis procedures and technical staff requirements
The Saudi Food and Drug Authority (SFDA) has warned designated laboratories against failing to participate in approved proficiency testing, emphasizing that repeated violations will subject the laboratory to strict measures. Regarding laboratory analyses, the new guidelines require laboratories to collect two separate samples, retaining the second sample for 60 days if the first sample yields positive results. Furthermore, any test contested by a client must be suspended until corrective actions are completed.
The updates also addressed technical staffing, stipulating that technical assessors must hold at least a bachelor's degree in specialized fields such as microbiology, chemistry, biomedical engineering, and pharmacy to ensure the quality of the assessment. They also indicated that a diploma would be accepted as a minimum qualification for field inspectors, provided they have completed documented training programs demonstrating competence and practical experience.
Validity of certificates and expansion of conformity areas
The regulations outline the mechanism for receiving exporting establishments into the Kingdom, granting conformity assessment bodies a 60-working-day period to conduct inspections following approval by the Authority. It clarified that inspection reports are subject to rigorous review by the Authority before issuing a final accreditation report or directing establishments to complete corrective action plans.
The guidelines stipulated a one-year validity period for conformity certificates from the date of issuance for specific products, including food additives, infant formula, energy drinks, and dietary supplements. The amendments also included expanding the scope of work for conformity assessment bodies, most notably the issuance of conformity certificates for shipments of various types of tobacco.
