Frequently Asked Questions
Definitions
Devices used to perform cupping including suction cups and suction pumps
Intended by the manufacturer to provide information for medical or diagnostic purposes by in vitro examination of specimens derived from the human body.
Components added to animal feed, which may or may not contain nutritional value, are intentionally added to the feed for technical, sensory, nutritional purposes and/or favorably improve animal production and performance or to satisfy the nutritional needs of animals.
A Product obtained from a blend of Nicotiana Tabacum and / or Nicotiana Rustica species which has been flue- cured, air cured, fire cured or sweltered.
Physical manifestation of a product that contains the active ingredient(s) and/or inactive ingredient(s) that are intended to be delivered to the patient in individual doses.
Mixture of at least two feed materials, whether or not containing feed additives, for oral animal feeding.
Are mixtures of feed additives or mixtures of one or more feed additives with feed materials or water used as carriers, and is intended for incorporation in compound feeding stuffs, feed materials or water and not meant for direct feeding to animals.
Any products consisting wholly or partially of tobacco leaves as raw material which has been manufactured for the purpose of direct or non-direct smoking or absorption such as Cigarettes, Almeassel tobacco, Meassel Fruit flavored, cigar, as well as E-Liquids and Heated Tobacco Products which are used by Electronic Nicotine Delivery Systems (ENDS).
It means articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient. Examples of HCT/Ps include, but are not limited to, bone, ligament, skin, dura mater, heart valve, and cornea.
Any pharmaceutical product manufactured in a pharmaceutical dosage form and contain one or more of active substance used externally or internally in treatment of a disease in human, or prevent the disease.
Finished labeled products in pharmaceutical dosage forms, which are usually low risk ingredients that are intended to restore, correct, modify physiological functions by exerting pharmacological, immunological or metabolic actions.
Any plant or herb manufactured in a pharmaceutical dosage form, and presented with a medical claim.
A radioactive drug that can be administered safely to humans for diagnostic and therapeutic purposes.
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.
Medicinal products derived from a variety of natural sources or produced by biotechnology methods and other cutting-edge technologies. They include a wide range of products such as vaccines, blood and blood components, allergenics, advanced therapy medicinal products (ATMPs), recombinant proteins and biosimilars.
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.
Animal feed 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.
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.
Any instrument, apparatus, implement machine, implant device, in vitro reagent or calibrator, software, material or other similar or related article intended by the manufacturer to be used, alone or in combination for diagnosis, prevention, monitoring, controlling, treatment or alleviation of disease or injuries or compensation for injuries. It is also used for investigation, replacement, modification, or support of the anatomy or of a physiological process, supporting or sustaining life (Vital functions of a human being), control of conception or assist for that, disinfection of medical devices and supplies and providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body. It does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.
Combination Product:
A product consists of two or more of items that subject to different SFDA’s jurisdictions in terms of regulatory path, marketing and/or manufacturing. It includes:
- A) Integrated combination product:
- • A product consists of two or more regulated components that are combined/integrated as a single product.
- B) Non-integrated combination product:
- • A product consists of two or more separated items that are contained in the same package. [Co-packaged combination product].
- • Any regulated product packaged separately where the labeling information refers to be used with another specific regulated product where both are
required to achieve the intended purpose of use.
- [Cross-labeled combination product].
Food products used to supplement the normal diet, which contain ingredients weather alone or in combination, that have a nutritional or physiological effect. They have different forms of packaging. A food supplement consists of one or mixture of the following components or others: vitamins, minerals, fatty acids, amino acids, enzymes, Prebiotics and Probiotics, collagen, dietary fibers, melatonin, propolis, pollen, herbs or food herbal extracts.
Services provided by the PCS.
- -Product Classification service.
- -Product Classification inquiry service.
- -Inquiry service about regulatory product status.
- -Inquiry service for appeal requests.
It is a service that allows companies, investors, the public sector, and related parties to classify their products and know whether or not the product is subject to registration, based on SFDA standards and products classification guidance.
A service provided by the Product Classification Department to classifying the combination product, by determining the leading sector that is responsible for registration and regulation of the product and consulted sector that evaluate the ancillary part of the combination product.
It is a service where the company has the right to submit an appeal or objection on a classified decision within 30 days through the electronic system (PCS) and submit justifications to be reviewed .
A free service provided to innovators and researchers aimed to support innovation by clarifying the regulatory pathway for the innovative product in accordance with the existing regulation of the Saudi Food and Drug Authority
- - 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.
Guidelines and regulations for classifying and organizing products
General
- - Products subject to MD sector regulation and supervision.
- - 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 and require Medical Device Importation License (MDIL).
- - Products classified as non IVD, and subject to MD sector regulation and supervision and require Medical Device Importation License (MDIL) .
- - Products classified as contains biomaterials, and subject to MD sector regulation and supervision and require Medical Device Importation License (MDIL) .
- - 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\drug 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 veterinary herbal medicinal product, and subject to drug sector regulation and supervision.
- - Products classified as food, and subject to food sector regulation and supervision.
- - Products not considered under SFDA supervision and regulation..
- - Products classified as clearance, and subject to operation sector supervision and regulation.
- - Products classified as combination product leading sector (drug sector)
- - Products classified as combination product leading sector (medical device sector)
- - Prohibited from trading in Saudi Arabia
SFDA will determine the classification of a product mainly on statutory definitions. Other definitions included in the associated regulated guidelines will also be considered. The SFDA will base its judgment on the current scientific evidence and the understanding of the product characteristics like :
- - Primary mechanism of action.
- - Intended uses.
- - Claims.
- - Active ingredients.
Moreover, the SFDA believes that global regulatory convergence is critical in achieving cooperation among regulatory bodies.
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.
For more information on how to make an appeal:
https://www.youtube.com/watch?v=X1QPhAaWp3k
Incomplete document or classification request cannot be done through the PCS Email; you must apply on the product classification System to receive an approved classification decision by SFDA.
Yes, classification decision is valid for one year from the date of classification.
That is because of the regular updates in regulatory standards and guidelines.
There is no certificate or paper letter, however; the applicant will receive an e-mail about the classification decision and it is 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. Non-refundable.
Contact us by e-mail: PCS@sfda.gov.sa
Or Call Business Support Center (19999)
- - 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.
You can view some of the classified products through SFDA’s classification guidance, such as:
- - Product Classification Guidance
- - Combination Products Classification Guidance
- - Borderline Product Classification Guidance
You can contact SFDA’s call center (19999) and submit a technical support request.
- - 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, ZATCA, KACST etc.
- - SFDA departments and branches.
- - Inventors and researchers.
Information required is:
- - The letter should be written to: product classification department
- - Name of delegated person.
- - The scope of delegation.
- - Certified by the Chamber of Commerce.
The allowed period is 30 days, after that the application will be canceled, and a new application must be submitted.
After receiving the SADAD bill number, you have 30 days to complete the payment, after that period the bill is canceled.
You can get the receipt after contacting SFDA’s call center (19999) and submit a request for a SADAD bill receipt.
You can contact SFDA’s call center (19999) and submit a technical support request.
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