المملكة: A maximum of 60 days for compliance authorities to complete inspection of export facilities to the Kingdom

Subtracted The Saudi Food and Drug Authority has issued a comprehensive update to the guide for requirements for appointing conformity assessment bodies, including strict requirements that include the obligation of field inspection, and subjecting laboratories to precise proficiency tests, to ensure the highest standards of safety and quality for imported and local products.

The Saudi Food and Drug Authority revealed the launch of the updated third edition of the guide for requirements for the regulation for appointing conformity assessment bodies inside and outside the Kingdom.

The authority explained that this regulatory move is based on Article Twenty-Two of its system issued by royal decree, which aims to establish precise controls and requirements for licensing private laboratories and conformity verification offices.

The new amendments confirmed the obligation of conformity assessment bodies that issue certificates to conduct all inspection operations “on the field” at the facility’s headquarters, rejecting any leniency or exception in this regulatory procedure.

The authority warned of violations, Required to immediately stop granting certificates in the event of suspension, reduction or cancellation of the activity of the entity appointed by the authority or accrediting body.

The updates indicated the necessity of informing “Food and Drug Administration” immediately informs of any changes occurring in the data of the conformity body or facility that has obtained the certificate, to ensure continuity of reliability and updating of records.

The updated regulations stressed the necessity of including the unified number “700” and the industrial license number in the quality management systems certificates, while matching the trade name precisely and not being satisfied with the trademark only.

The Authority touched on the laboratory aspect, as it developed “technical proficiency testing” programs to evaluate Laboratory performance and comparison of their results with approved statistical methodologies in accordance with the requirements of the international standard “ISO17043/IEC”.

She drew attention to the fact that in the event of The laboratory receives an “unsatisfactory” result in the proficiency tests, it is obligated to provide an analysis of the root causes and implement a corrective action plan within a specific period.

It indicated that repeating the violation or failure to send laboratory results without acceptable justification gives the authority the right to take appropriate action in accordance with the penalties clause approved by it.

The instructions added the obligation of the designated laboratory to keep the “B” sample for 60 days in the event that the “A” sample is positive, to ensure transparency and provide a safe path in the event of acceptance. Objection request received from the client.

With regard to technical personnel, the Authority required precise academic qualifications that include a bachelor’s degree as a minimum for technical evaluation work, and a diploma for field inspection tasks in specific scientific and engineering specializations.

The required specializations included precise biological fields such as microbiology, analytical chemistry, pharmacy, biomedical engineering, and nuclear physics, to ensure the highest levels of competence in the control of food, cosmetics, and medical devices.

The Authority expanded the scope of appointment to include issuing Certificates of conformity for all types of tobacco consignments, such as cigarettes, honey, and e-liquids, in addition to sensitive food products such as energy drinks, nutritional supplements, and infant food.

The regulations obligated conformity bodies to provide the authority with reports assessing the extent of compliance, including reports of food factories that were “rejected” from granting “HACCP” and “ISO/IEC22000” certificates, to track non-compliant establishments and tighten control over them.

It specified “Food and Drug Administration” set a strict time frame of 60 working days for conformity assessment bodies to complete inspections on establishments wishing to export to the Kingdom, starting from the date the body obtains approval.

It stressed that all inspection reports submitted are subject to review and final technical audit by the authority’s specialists, to make the final approval or rejection decision or direct the completion of the corrective plan procedures.