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Frequently Asked Questions


An article intended for use in the diagnosis, cure mitigation, treatment, or prevention of disease and which intended to affect the structure or function of the body.
Any substance or mixture intended to be placed in contact with the external parts of the human body. (epidermis, hair, nails, lips and external genital organs), Or with the teeth and the mucous membranes of the oral cavity, With a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors.
Any substance that being processed, semi-processed or unprocessed, which intended for direct human consumption or used in manufacturing, preparing or treating a foodstuff. It does not include perfumes, tobacco and any other substances used only as drugs.
Biomaterials used in diagnosis or treatments of humans or animals, including blood products, vaccine and serums. Moreover, all that is made of human or animal origin or contains any of them, extracted from it, or modified using the genetic engineering technique.
It is a substance or formulation used for treatment, prevention or used to diagnose animals’ disease. Also, used to change or reform the physiological functions of the animal.
Fodder is what feeds the animal whether it is single substance , mixed substances , manufactures or semi- manufactured , raw materials or material involved in manufacture, preparation or processing of feed ,whether from plant or animal sources or from aquatic organisms.
Pesticide: is Any substance intended for preventing, destroying, attracting, repelling or controlling any pest .Which, include unwanted species of plants or animals during the production, storage, transport, distribution, processing of food, agricultural Commodities, animal feeds or administered to animals for the control of ectoparasites.
Medical device: ‘Medical device’ means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:
  • - Diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • - Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
  • - Investigation, replacement, modification, or support of the anatomy or of a physiological process,
  • - Supporting or sustaining life,
  • - Control of conception,
  • - Disinfection of medical devices,
  • -- Providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body;
A product where there is a difficulty in determining the regulatory path either as it does not meet the definitions provided above by this guidance or as the characteristics of the product is not clear identified.
  • - Cope with the emergence of challenging advanced, complex, modern and innovative health products.
  • - Cover the regulatory scheme of these products.
  • - Ensure consistent/appropriate Pre and/or Post market regulation.
  • - Provide a consistent, predictable and transparent approach to assign combination products to a lead agency.
  • - Improve the internal processing and frameworks by enhancing capabilities and simplifying the evaluation pathways.
Products are classified through an electronic platform via the link: http://pcs.sfda.gov.sa/ .Where the companies are able to classify their products and get to know the eligibility of the products and whether it is subject to registration. The classification exclusively based on the SFDA criteria and products classification guidance. It is important to point out that this procedure is an optional choice for companies and does not replace registration for other SFDA electronic systems.
  • - Products classification is an optional service for companies who could not identify the accurate sector of registration.
  • - In certain cases, companies directed to classify their products under SFDA.
  • - Each company who has each classified their product is an eligible to register on the SFDA electronic systems before marketing.
  • - Product Classification service
  • - Product Classification inquiry service.
  • - Inquiry service about regulatory product status.
  • - Inquiry service for appeal requests.
  • - Dealing with comments and completing applications during the priority review for products applied on PCS.
  • - Dealing with all system discrepancies and resolve issues with relevant IT departments.
  • - The regulatory status for products (investors and companies).
  • - The interference and differences among other government agencies.
  • - Inconsistencies between other notified and governmental agencies.
  • - The need of ports and customs to know the regulatory status of products
  • - The need of branches and other internal departments
  • - The need of SFDA inspector to obey the law and violations for unlicensed products.
  • - Facilitating internal licensing and assessment processes.
  • - Save time, money and effort.
  • - Cope with international regulations and legislations in regulatory bodies and encourage local and regional industries.
  • - Create rich regulations for global investment for researchers and inventors.
The types of products which may fall in to the SFDA category include:
  • - Cosmetics.
  • - Food products, including, in particular, food supplements.
  • - Herbal products.
  • - Medical devices.
  • - Biocides.
  • - Machinery/laboratory equipment.
  • - There is also a borderline between medicinal products and medical devices.
  • - Combination products.
  • • Products subject to MD sector regulation
  • • Products classified as general laboratory uses, and subject to MD sector regulation and supervision
  • • Products classified as IVD, and subject to MD sector regulation and supervision
  • • Products classified as non IVD, and subject to MD sector regulation and supervision
  • • Products classified as contains biomaterials, and subject to MD sector regulation and supervision
  • • Products classified as herbal products, and subject to drug sector regulation and supervision
  • • Products classified as health product, and subject to drug sector regulation and supervision
  • • Products classified as cosmetic, and subject to drug sector regulation and supervision
  • • Products classified as medicinal product, and subject to drug sector regulation and supervision
  • • Products classified as veterinary product, and subject to drug sector regulation and supervision.
  • • Products classified as food, and subject to food sector regulation and supervision.
  • • Products are considered: not under SFDA supervision and regulation.
To classify a product in SFDA:
  • - SFDA Regulatory definitions (Drug, Food and Medical Device).
  • - Primary mechanism of action.
  • - Intended uses.
  • - Claims.
  • - Active ingredients.
  • - Similar products in reference agencies.
  • - Previous decisions.
  • - Product list available in SFDA sectors.
  • - Seek a scientific opinion.
    • - Go to SFDA website http://www.sfda.gov.sa/Ar/Home
    • - Click Eservices icon, product classification system then click the link.
    • - Choose company login icon
    • - Click registration icon and fill the form with all required information:
  • User name.
  • Password.
  • The name of the company in Arabic.
  • The name of the company in English.
  • The account manager name.
  • The legal capacity.
  • Copy of the authorization letter for the account. manager certified from the chamber of commerce.
  • Email address.
  • Phone number.
  • Cell – phone number.
  • Commercial register number.
  • after complete all the information click register.
The company or applicant may apply an appeal of classification decision within 30 days on PSC system with all justifications and supporting documents and it will be reviewed.
  • Products cannot be classified by the PCS Email; you must apply on the System to receive an approved classification advice by SFDA.
  • The product classification consulting service is available only to the internal channels within SFDA including ports, branches, and technical departments.
Yes, there is an expiry date for the classification certificate, the classification decision is valid for one year from the date of the approval, that is because of the regular updating of the changing the laws, standards, and guidelines at SFDA as well as in the global regulatory agencies.
It is not allowed at all, those who exploit the logo of SFDA or the classification number for advertising will be exposed for legal and judicial accountability, and they will be subject to the sanctions approved by laws and regulations.
There is no classification certificate; however; the applicant will receive an e-mail about the classification decision and it viewed electronically via PCS. Currently, the certificate issued only if requested by government agencies.
Yes, there is a charge for the classification service, 1000 SR per product.
Yes, there is a guidance for SFDA products classification and, and it will be published soon on the SFDA website and updated periodically.
  • Contact us for product classification by e-mail:
  • PCS@sfda.gov.sa
  • Or Call Business Support Center (19999)
Products reviewed according to the product classification criteria. The leading sector will be then determined after studying the product in all scientific and regulatory aspects.
  • - The purpose of using the product as provided by the manufacturer.
  • - User instructions as provided by the manufacturer.
  • - Product mechanism of action.
  • - Classification request letter indicating the name of the product and the name of the person responsible for the request with his contact information.
  • - Attach a product catalog with a clear image of the product.
  • - Attach the quality certificate from the manufacturer.
  • - Product registration certificate in the country of origin, if available.
  • - Identification card and product (artwork).
  • - Attach a product declaration of conformity (D.O.C).
  • - A classification letter from the manufacturer of the product indicating the product classification.
  • Currently, this service is available to SFDA employees by providing PCS access to check previous classification decisions.
  • As for non-SFDA staff, they can inquire about lists of published products such as lists of medicines / food / medical devices / cosmetics etc. which registered and available on SFDA website.
You can get Product regulations through the SFDA website, which usually linked to special items and numbers inside each technical list, related to the product, SFDA presents and publishes the circulars and decisions published on SFDA website.
If you face a technical problem, you can contact the Business Support Center at 19999 or contact the Product Classification Department by e-mail PCS@sfda.gov.sa
  • - Pharmaceutical companies and agents.
  • - Medical devices companies and agents.
  • - Companies and importers of food products.
  • - Local and imported cosmetics factories.
  • - Other governmental agencies, such as the Ministry of Health and SASO etc.
  • - SFDA departments and branches.
Information required are:
  • - The letter should be written to: product classification department
  • - Name of delegated person.
  • - The scope of delegation.
  • - Certified by the Chamber of Commerce.
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