SFDA CONFORMITY ASSESSMENT FOR FOOD SHIPMENTS TO BE EXPORTED TO THE KINGDOM OF SAUDI ARABIA
1，Mask SFDA Introduction
Purpose
The purpose of this guidance is to specify and clarify the requirements and recognized standards for obtaining Medical Devices Marketing Authorization (MDMA) of medical masks, in order to place them on the market within the KSA.
Scope
This guidance applies to the following: - Manufacturers, authorized representatives, importers and distributers - Surgical/medical and N95 respirator masks used to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids and particulate materials.
Background
SFDA/MDS has issued this guidance document in reference to the following: - Article Three of “The Law of Saudi Food and Drug Authority” - Requirements specified in “Guidance on Requirements for Medical Device Marketing Authorization (MDS – G5)”.
Requirements
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2，COSMITIC SFDA
AGREEMENT NAME Certificate of Conformity Issuance for Food Products
PROGRAM MANDATED BY Saudi Food and Drugs Authority (SFDA)
PROGRAMME SCOPE
All regulated food products should be accompanied by a Certificate of Conformity (CoC) issued by an entity authorized by SFDA to ensure conformity of them with the applicable SFDA technical regulations and standards
CoC USE
The CoC facilitates customs clearance of the imported shipment by taking the fast track to end SFDA procedures immediately at customs ports and release the shipment on the same day
REGULATED PRODUCTS Food products in certain countries as mentioned in Annex 1
ASSESSMENT SCHEME
The assessment scheme consists of:
*Documentary verification
* Shipment inspection
* Laboratory Testing
* Loading Supervision and Container Sealing
TESTING AND APPLICBALE STANDARDS
Test reports from the following entities will be considered:
*Conformity Bodies Laboratories
* Laboratories with valid ISO 17025 accreditation Applicable standards are Saudi/GSO Technical Regulations and Standards
INSPECTION
* To verify the requirements that are not covered by testing such as labelling requirements and packaging conditions
* Food products require pre-shipment inspection, containers’ loading supervision and sealing
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Expert use of the SABER system with assistance from SWA Solution will ensure you benefit from rapid processing and issuance of Certificates of Conformity and a reduction in the time it takes importing your products through Saudi customs.
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About SWA Solution
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