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Sfda requirements sa Please visit SFDA’s website at for the latest update . Why This Matters: Staying compliant with SFDA regulations ensures your products can be marketed without legal hurdles, enhancing your brand’s credibility and market reach. Guidelines for Investigational New Drugs (IND) Requirements. MDS-REQ-011-V2/230323 Page 9 of 33 SFDA in vision 2030 . 3. For ensuring that safety regulations are followed in all medical operations involving radiation emitting devices in the country. China CFDA(sfda) Regulations; Other Products Top Articles The Clinical Trials administration aims to provide it services professionally by evaluation, registration and monitoring the Clinical Trials conducted in Saudi Arabia and contribute to the protection of clinical trial subjects, also SFDA in vision 2030 . sa For Comments Drug. However, presentation and content of part 1 (summary of the dossier) is similar for both types and will differ in Parts - What are the file’s requirements to submit the product through verification and abridged process? Refer to the section of requirements. SFDA may conduct onsite visits on healthcare facilities and third party service contractors to ensure they apply the requirements of quality, safety and effectiveness of medical devices at healthcare facilities. Promote. General Rules Submitting Labelling to SFDA 1. Related guidelines • Guidance for Presenting PIL and Labeling Information of Herbal and Health Products • General Rules for Products containing Vitamins and Minerals • SFDA’s Products Classification Guidance • Guidance for submission Guidance on SFDA Requirements for Quality Assurance Programs for Radiation Emitting and Imaging Devices (MDS-G15) 2023-03-22. Where the CAB is unable to fulfill the SFDA requirements, the SFDA shall withdraw the designation until the shortcoming has been corrected. The final version was published in August 2021. SFDA in vision 2030 . th. − The following medical devices/supplies are exempt from the The data requirements for each application will differ, depending on the drug submission type. Vision Realization Office ; National Transformation Program ; Health Sector Transformation Program ; Guidance on Technical Requirements for Food and Water Manufacture Guidance on Technical Requirements for Food and Water Manufacture 2021-10-20. Clinical Trials in Special cases (a) Update: Trials on drugs related to national initiatives from SFDA Regulations and Requirements for Conducting Clinical Trials – Clinical Trials in Special cases (b) Delete: -Response timeline do not exceed 15 working days. Food Medical Devices. Vision Realization Office ; National Transformation Program ; Health Sector Transformation Program ; Guidelines for Variation Requirements Guide. Regulations and Requirements for the clearance of medicines, pharmaceutical products, medical devices, and food products that arrive for pilgrims use. SFDA Vaccine Guidelines In 2020 the SFDA published guidelines on vaccines under the title Clinical Considerations for Vaccines. 4 DS-G-094-V3. E. 3. - The height of the wellhead above the ground must be 10 to 20 cm. - Requirements for Safe Use of Medical Device inside Healthcare Facilities (MDS REQ3) published on the SFDA website. Vision Realization Office ; National Transformation Program ; Requirements for Safe Use of Medical Devices Inside Healthcare Facilities (MDS-REQ 3) Requirements for Safe Use of Medical Devices Inside Healthcare Facilities (MDS SFDA in vision 2030 . Healthcare providers and transporters are exempt. 2025-01-01. Document Control Version SFDA in vision 2030 . 🌐 Stay Tuned! This SFDA in vision 2030 . FD/GSO 2233 Requirements for Nutrition and Health Claim In The Food SFDA. • Sector: Operation Sector. 4 Document Control Version Author This document may affect the SFDA guidelines and should be read in conjunction with other relevant and applicable guidelines that published in SFDA website: Drug sector at SFDA sets the rules for registering different types of drugs. • Ports: Customs Ports in Saudi Arabia that allow supplying products that are subjected to the control of the Operation Sector. FD/GSO 2055-1 SFDA. Vision Realization Office ; National Transformation Program ; Health Sector Transformation Program ; National Industrial Development and Logistics Program ; نظرة عامة Laws and Regulations Guidelines Drugs Circulars forms − The SFDA provide the MDMA certificate for the manufacturer, including its name. The content and timing should also be according to the ICH-E2C (R2) guidance. Applying Date : 2022-07-25 . Vision Realization Office ; National Transformation Program ; Health Sector Transformation Program ; National Industrial Development and Logistics Program ; نظرة عامة Laws and Regulations Guidelines Drugs SFDA in vision 2030 . Regulation . The SFDA emphasises implementing a reconciliation procedure between the MAH and the local QPPV, including the signal detection activity outcomes. Food List. 2020-12-30. Lay down the conditions and requirements, which must be met by the competent register, the application form submitted or SFDA database. Such guidance helps applicants meet the expectations of regulators. Vision Realization Office ; National Transformation Program ; Health Sector Transformation Program ; National Industrial Development and Logistics Program ; نظرة عامة Laws and Regulations Guidelines Drugs Circulars forms SFDA REQUIREMENTS FOR FOOD. Please consult with your administrator. • Inspectors: Operation Sector Inspectors at SFDA. Vision Realization Office ; National Transformation Program ; Requirements for Inspections and Quality Management System for Medical Devices (MDS – REQ10) 2022-06-19. Article Six For electrical medical devices, colours of conductors’ insulators shall be in accordance with the Saudi Building Code –Electrical Requirements part 401 of SBC and the Saudi standard Requirements - Notifying the SFDA and submitting information and documents related to the violating medical devices through: o National Centre for Medical Device Reporting (NCMDR) o Saudi Vigilance o Call Center (19999) Reporting Channels. e. Conditions and requirements for obtaining permits for drugs , pharmaceuticals , and cosmetics products for individuals for personal use level issued by the SFDA”. Food, Drugs, Medical Devices Guide. Has the page content helped you? Sector in the SFDA manage information and material submitted in accordance with the Regulatory framework for Drug Approvals (version 5. Such rules are developed by examining the current and future competencies of its evaluators. FD/GSO 839 “Food Packages - Part 1: General Requirements”. The Authority. Human Drugs Submission. It SFDA in vision 2030 . Guidelines for Bioequivalence Guide. SFDA in vision 2030 . 7 %µµµµ 1 0 obj >/Metadata 6468 0 R/ViewerPreferences 6469 0 R>> endobj 2 0 obj > endobj 3 0 obj >/ExtGState >/XObject >/ProcSet[/PDF/Text/ImageB/ImageC Classificationfeedb@sfda. FD/GSO 2333 Microbiological Criteria for Foodstuffs SFDA. The SFDA shall publish a list of the designated CABs and the tasks for which each has been designated. Abdullah Alghuraibi. The SFDA oversees three primary industries: food, pharmaceuticals (drugs), and medical devices. o If conditions and requirements are not satisfied, SFDA will issue an “Objection Letter” with justifications. Vision Realization Office ; National Transformation Program ; Requirements for Inspections and Quality Management System for Medical Devices (MDS To be sure medical device manufactures fulfil safety, performance and quality requirements; this guidance has been published in order to clarify regulatory and technical requirements to be Drug sector at SFDA sets the rules for registering different types of drugs. Guidelines for Bioequivalence 2024-04-29. The Saudi Food and Drug Authority (SFDA) cover all medical SFDA Guideline on Classification of Advanced Therapy Medicinal Products Version 1. 4. Sitemap; About SFDA; Contact CEO; Ask SFDA Speaker; RSS Feed; SFDA in vision 2030 . Lay down the conditions and requirements, which must be met by the competent SFDA in vision 2030 . provide China FDA,SFDA,CFDA,MOH,MOA,AQSIQ,CNCA,CIQ registration approval license for cosmetics,health food supplement,medical device,IVD,drug,infant milk powder,dairy,pet food ,disinfectant etc. This article will explain the SFDA requirements and regulations for conducting a clinical trial in Saudi Arabia. In this article, we will look at the key requirements for pharmaceutical products’ primary and secondary packaging, along with Patient Information Leaflets (PIL), and how to comply with Saudi Arabia drug laws. Conditions and requirements for obtaining permits for drugs , pharmaceuticals , and cosmetics products for individuals for personal use Required Documents Required Documents Notes 1 Required forCopy of MDEL license to practice the importer and exporter. activity of importation and re-exportation of medical radioactive materials (issued by the SFDA). For Inquiries Variation. Saudi Food & Drug Authority Mission Protecting the community through regulations and effective controls to ensure the safety of food, drugs, medical devices, cosmetics, pesticides and feed. Dr. Vision Realization Office ; National Transformation Program ; Health Sector Transformation Program ; Regulation and Requirements for Conducting Clinical Trials on Drug. Your support ID is: 17657171356393562623 SFDA in vision 2030 . The following technical regulations and standards are related to food product packaging: SFDA. requirements and guidelines published on SFDA website. This guidance provides recommendations on the minimum preclinical data requirements for human medicinal and biological products. FD/GSO 382 Maximum Limits of Pesticide Residues In Agricultural and Food Products Halal Food - Part 1 : General Requirements SFDA. FD 2333 and guidelines published on SFDA website. According to SFDA GVP guidelines, the PSUR report in the Kingdom of Saudi Arabia (KSA) is accepted using the same format as described for PBRER in the guidance of ICH-E2C (R2). Has the page content helped you? Page Feedback Choices. 2020-10-20. The required preclinical data depends on the type of submission. Labelling provided to SFDA shall be complied with: the relevant regulatory requirements applicable in one or more of the jurisdictions of Australia, Canada, Japan, the USA and the EU/EFTA (SFDA requires copies of all labelling as they were submitted and approved by the After completion of the required documents, the SFDA will evaluate the application within (60 days) and take a decision as follow: o Once conditions and requirements are satisfied, SFDA will issue a “No Objection Letter”. Further, data integrity is the SFDA in vision 2030 . 2024-11-20. 2025-01-03. Drugs Requirement. sa -G 002 V7 231119OPS. • Clearance: Approval issued by Operation Sector to customs permitting the entry of The Saudi Food and Drug Authority (SFDA) has laid down strict regulations regarding pharmacautical labeling. Article 5 Taking into account relevant international standards, the SFDA shall develop and update food standards and regulations. 6. The required preclinical data SFDA's pricing rules The Rules for Pharmaceutical Products Pricing which include the general requirements and criteria for pricing a pharmaceutical product and constitute the general SFDA requirements for labeling and Packaging for investigational medicinal products (IMP) SFDA requirements for labeling and Packaging for investigational medicinal products (IMP) Publication Date : Applying Date : 2012-12-05 . These regulations cover various aspects, including structural requirements, storage conditions, and health and safety procedures. SFDA shall have the right to stop or revoke an ad in the event of violating the rules and requirements of the guide herein. SFDA should be Informed immediately if the establishment cannot keep fulfilling the provisions and license requirements. SFDA’s Product Specific Bioequivalence Guidance SFDA’s Product Specific Bioequivalence Guidance 2022-05-24. Clinical Trials SFDA in vision 2030 . Good SFDA. Classificationfeedb@sfda. Safe Use of Medical Devices) Reference: 22. TECHNICAL REQUIREMENTS Saudi Food and Drug Authority (SFDA) minimum technical requirements for cabinet x-ray systems are as follows: 1. These rules will help the applicants to decide whether to submit their drug applications or not. Guidance on Technical Requirements for Food and Water Manufacture Used Well - A closed, brick-roofed room must be built around the well. Conditions and requirements for obtaining permits for drugs , pharmaceuticals , and cosmetics products for individuals for personal use SFDA in vision 2030 . 2024-11-27. 3-170511 Document Control . SFDA Cosmetic Products Regulation is the main regulatory SFDA in vision 2030 . Herein we give a guidance on the minimum preclinical data requirements per type of submission. 2024-04-18 The SFDA Warehouse Regulations. General classification for supply 15. Contribute to reduce . Scope This guidance applies to manufacturers and authorized representatives of surgical sutures with/without needles used for general soft tissue approximation and wound closure/ support. Vision Realization Office ; National Transformation Program ; Requirements for Post-Market Surveillance of Medical Devices (MDS – REQ11) Requirement. Vision Realization Office ; National Transformation Program ; Health Sector Transformation Program ; National Industrial Development and Logistics Program ; Pharmacovigilance Requirements. 21. Inform the SFDA immediately if the establishment cannot continue to meet the provisions and license requirements. Category. Validation The product file will be validated in technical and business bases to ensure the applicant fulfills the requirement. Drugs, Medical Devices. Medical Devices. Version. This is SFDA in vision 2030 . They provide clear definitions for key terms related to nutrition To be a leading international science -based regulator to protect and promote public health Of these, 24 were related to SFDA requirements, 18 to "ISO 17065" criteria, and two to "ISO 17021" criteria. Guidebook For the Preventive Requirements of the Establishments of food, feed, and drug products, cosmetics and medical equipment and ways of dealing with and responding to employees’ injuries Requirements for Conducting Clinical Trials – and related bodies. They could be part of the SFDA registration requirements for some drug products. These requirements had evolved significantly since 2009 when SFDA applied the ICH guidelines. 2 Required Documents to List the Establishment According to the responsible person: You can see “appendix 1” to know the mechanism and required document to notify cosmetic establishment. Vision Realization Office ; National Transformation Program ; Health Sector Transformation Program ; Guidelines Good Manufacturing Practice (GMP) Guidelines 2023-01-05. When developing guidelines, of surgical sutures with/without needles to comply with the SFDA Requirements for Medical Devices Marketing Authorization (MDS-REQ 1). 2024-03-05. It The SFDA sets and enforces regulations to ensure that cosmetics marketed in the country are safe for consumers and comply with international standards. 5) for all pathways (Regular,. 7. MDS-G-015-V2/230907 Qualifications and Responsibilities of Staff Radiologists, radiologic technologists, medical physicists, and all supervising physicians are responsible for ensuring the safety of The criteria are being actively updated in the SFDA classification guidelines, where the outcome of the classification provides the following: Jurisdiction: whether it SFDA in vision 2030 . 0). applicants should not modify the overall organization of the eCTD as outlined in this guideline): Medical Devices Regulation and Requirements (SFDA Updates) Eng. Vision Realization Office ; National Transformation Program ; Requirements on Importation and Shipments Clearance of Medical Devices (MDS-REQ5) 2023-09-17. the incidents related to calibration, maintenance, poor storage, transportation and disposal medical devices. Search. The Saudi Food and Drug Authority (SFDA), the country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to innovative medical devices. 4. Vision Realization Office ; National Transformation Program ; - Overview of Sterilization requirements - Relevant standards - Advice & recommendations . 6 Article Seventeen Gas cylinders for medical use shall bear the colour(s) corresponding to the gas(es) they contain in accordance with the the Saudi standard entitled “Gas cylinders for medical use SFDA in vision 2030 . Attaching copy of the quality management system certificate (ISO 13485) or the inspection visit report, or providing proofs of the implementation of the quality management system, where the quality manual attached on the SFDA’s website is filled out: Protecting the community through regulations and effective controls to ensure the safety of food, drugs, medical devices, cosmetics, pesticides and feed . Advertiser is responsible for legal damages caused by the violating ad to the guides, regulations, and laws issued by SFDA. Inform the SFDA about medical devices that violate the provisions and Requirements for Inspections and Quality Management System for Medical Devices (MDS – REQ10) 2022-07-28 For more information, please refer to the SFDA’s Products Classification Guidance. − Requirements for obtaining a MDMA are harmonized with international regulations, which facilitates its circulation inside and outside the KSA. Vision Realization Office ; National Transformation Program ; Health Sector Transformation Program ; National Industrial Development and Logistics Program ; نظرة عامة Laws and Regulations Guidelines Drugs Circulars forms Circulars FAQ Sector Committee. Article 6 The SFDA shall adopt Risk-Based Analysis approach when issuing and updating regulations and The SFDA Requirements of Nutritional Labeling are noteworthy for their emphasis on clarity and transparency in food labeling. Vision Realization Office ; National Transformation Program ; Circular on General compliance with transportation and storage requirements Circular on General compliance with transportation and storage requirements Publication Date : 2022-07-25 . 20. Vision Realization Office ; National Transformation Program ; Health Sector Transformation Program ; Guidelines for Bioequivalence Guidelines for Bioequivalence 2024-05-21. Vision Realization Office ; National Transformation Program ; Health Sector Transformation Program ; Guidelines for Veterinary Antimicrobial Products Classifications. SFDA MDS-REQ3 (Requirements for the . Capable of rapidly shipping fruits, vegetables, sugar, grains, spices, and meat to the Arab nations, India has emerged as the top food exporter to management system (QMS) in accordance with SFDA requirements for medical devices QMS. Guidance on the development of IVDs requirements of medical devices and supplies published on the SFDA’s website. sa For products classification requests: PCS@sfda. Data Requirements for Veterinary Medicinal Products Guide. FD/GSO B. FD/GSO 1016 SFDA. The validation involves two steps: 1 Performance targets for every step are provided at the end of this part (section 3. The Saudi Food and Drug Authority (SFDA) implements stringent regulations for warehouses to ensure the safety and quality of stored products. According to the SFDA GVP guidelines, the marketing authorization holder (MAH) is responsible for implementing a compliant PV system. FD/GSO 9 “Labeling of prepackaged food stuffs”. It represents the current thinking of the SFDA in vision 2030 . Medical Devices Sector. Drugs Regulations and Requirements for the clearance of medicines, pharmaceutical products, medical devices, and food products that arrive for pilgrims use SFDA in vision 2030 . Please provide us with your suggestions and feedback about this guideline and practical directions to To be a leading international science -based regulator to protect and promote public health Question What are the obligations of importers and distributors regarding medical devices post-marketing? Answer SFDA in vision 2030 . Vision Realization Office ; National Transformation Program ; Health Sector Transformation Program ; National Industrial Development and Logistics Program ; Brief: Overview of Sterilization requirements Relevant standards Advice & recommendations Work Shop Link Remotely : Click Here 3. Food. Vision Realization Office ; National Transformation Program ; Health Sector Transformation Program ; Guidelines, Requirements and Fees. Vision Realization Office ; National Transformation Program ; Health Sector Transformation Program ; Regulation and Requirements for Conducting Clinical Trials on Drug Regulation and Requirements for Conducting Clinical Trials on Drug 2025-01-05. import conditions and requirements issued by SFDA”. For products which their manufacturing sites are not registered at SFDA, does SFDA SFDA in vision 2030 . Name of the delegated establishment, its address and its commercial registration number. Details Drugs . the import conditions and requirements issued by SFDA”. Sitemap; About SFDA; Contact CEO; Ask SFDA Speaker; RSS Feed; The SFDA is the most stringent authority in the MENA region due to their continuous development of Saudi pharmaceutical laws and investment in the growth of local scientists since 2004. -For products which their manufacturing sites are not registered at SFDA, does SFDA approve the product without site inspection? If the product manufacturing site is located in one of the countries mentioned in The Chief Executive Officer of the Saudi Food and Drug Authority (SFDA), H. the quality and efficiency of health care. The following rules/conditions if met, the submitted drug application will be SFDA. Vision Realization Office ; National Transformation Program ; Health Sector Transformation Program ; National Industrial Development and Logistics Program ; نظرة عامة Laws and Regulations Guidelines Drugs نظرة عامة Laws and Regulations Guidelines Drugs Circulars forms Circulars FAQ Sector Committee. Preventive requirements and the way of dealing with and responding to food, feed and drug products establishments, cosmetics and medical equipment have been prepared to reduce COVID-19. SFDA Saudi Food and Drug Authority. However, all the required data should be in accordance with the eCTD structure (i. These rules will The purpose of this document is to provide a guidance on planning to prepare and design postmarket clinical follow up studies related collecting and submitting clinical data for medical Every submission to the SFDA is required to include certain preclinical data to support the safety and efficacy of the pharmaceutical product. 1. Has the page content unless obtaining the SFDA’s approval. Medical Device marketing requirements are described SFDA in vision 2030 . MD/ISO 20776-1:2017 : الأطراف الصناعية وتقويم العظام - المصطلحات - الجزء2: مفردات متعلقة بالأطراف الصناعية الخارجية ومستخدميها clinical objectives of treatment, and functional requirements of the orthosis : SFDA. It is required only if the radioactive Change to the regional requirements for applications that are outside the scope of the CTD Updating standards that are already in use within the eCTD Identification of new standards that provide additional value for the creation and/or usage of the eCTD Identification of Guide of cosmetics products import into Chinese Market-RJS MedTech Inc. Vision Realization Office ; National Transformation Program ; Controls and requirements that must be followed when importing honey and bee products into The Kingdom of Saudi Arabia. Medical Devices Guide. "SFDA": 8 Steps to Prepare Food Safely 2015-08-11 . These requirements are complementary to technical regulations and the Saudi approved 6 1. To increase the lifetime . The SFDA shall publish a list of the designated organizations and the activities for which each has The Saudi Food and Drug Authority (SFDA) has introduced new regulations for food establishments aimed at enhancing consumer transparency and safety, applicable to restaurants and food delivery apps. Comments@sfda. 0 Saudi Food & Drug Authority Drug Sector For requirements for medical devices and implantable medical devices, please consult SFDA Medical Device Department as appropriate. Every submission to the SFDA is required to include certain preclinical data to support the safety and efficacy of the pharmaceutical product. Author . The SFDA is responsible for ensuring the CAB has procedures in place to ensure its staff Part A: Preclinical data requirements Every submission to the SFDA is required to include certain preclinical data to support the safety and efficacy of the pharmaceutical product. The submission particulars have significantly transitioned from the 5. No Results Found Displaying 0 - 0 of 0 Sitemap; About SFDA Sunglasses shall comply with SFDA requirements and standards for ultraviolet radiation protection. Defenitions • Authority: Saudi Food and Drug Authority (SFDA). Work Shop Link Remotely : Click SFDA in vision 2030 . 3 DS-G-006-V6. Products Classification Guidance. SFDA. Page 3 of 14 Article Two The purpose of this document is to simplify the SFDA requirements in respect of using ionizing and/or nonionizing radiation emitting medical device for diagnostic, therapeutic or cosmetic purposes in healthcare facilities. Through this journey you will learn about the procedures and requirements of the facilities and products and clearing of consignments News Events Workshops ميديا 2025-01-01. Hisham S. Vision Realization Office ; National Transformation Program ; Health Sector Transformation Program ; National Industrial Development and Logistics Program ; Requirements for Safe Use of Medical Devices Inside Healthcare Facilities (MDS The requested URL was rejected. Industry representatives, as well as the staff of the SFDA responsible for the import conditions and requirements issued by SFDA”. All evidence submitted must comply with good clinical practice (GCP) guidelines. Scope This document applies to establishments and medical devices which referred to in (Article required cleaning methods to protect the health of citizens and residents. Guidance for Naming of Medicinal Products. These regulations will be implemented in two phases, with the first phase effective from November 30 2024 and the second from July 1 2025. Data Requirements for the Renewal of Marketing Authorizations for human medicinal products. Vision Realization Office ; National Transformation Program ; Health Sector Transformation Program ; Requirements for Licensing of Medical Devices Establishments (MDS-REQ9) Requirements for Licensing of Medical Devices Establishments (MDS-REQ9) 2022-08-18. FD/GSO 1863 “Food packages - Part 2: ‎Plastic package - General ‎requirements”. 5) for all pathways (Regular, Guidance on SFDA Requirements for Quality Assurance Programs for Radiation Emitting and Imaging Devices (MDS-G15) 2023-09-28 نظرة عامة Laws and Regulations Guidelines Drugs Circulars forms Circulars FAQ Sector Committee. Article 1: scope and definitions Scope: These requirements and conditions apply to all food products imported from the exporting countries into Kingdom of Saudi Arabia. The Authority Guide. The validation involves two steps: 3. Has the page content helped you? SFDA in vision 2030 . MD/ISO 8551:2019 : الأطراف SFDA in vision 2030 . Publish Date. Director, Regulations and Registration Support Dept. Vision Realization Office ; National Transformation Program ; Data Requirements for Veterinary Medicinal Products Data Requirements for Veterinary Medicinal Products 2022-11-06. Conditions and requirements for obtaining permits for drugs , SFDA in vision 2030 . OPS-G-002-V7-231119. Where the organization is unable to fulfill the SFDA requirements, the SFDA shall withdraw the designation until the shortcoming has been corrected. Lay down the conditions and requirements, which must be met by the %PDF-1. SFDA’s Product Specific Bioequivalence Guidance Guide. Vision Realization Office ; National Transformation Program ; Health Sector Transformation Program ; Regulations and Requirements for the clearance of medicines, pharmaceutical products, medical devices, and 19. 2/110821 These guidelines are adopted from the EMA Guidelines on the details of the products submissions for presentation to Saudi food and drug authority (SFDA). Appointing a contact officer with the NCMDR to carry out the tasks and responsibilities The SFDA shall develop technical regulations and standards for foodstuff, food businesses and food employees. Saudi Food And Drug Authority. Aljadhey, met with several company officials and representatives from the food, drug, medical devices, and medical products sectors in the Western Region. Vision Realization Office ; National Transformation Program ; Health Sector Transformation Program ; National Industrial Development and Logistics Program ; نظرة عامة Laws and Regulations Guidelines Drugs and guidelines published on SFDA website. - The floor of the well room must be made of cement concrete. When satisfied, the SFDA shall issue the organization with a Certification of designation. The Pre 5. Vision Realization Office ; National Transformation Program ; Health Sector Transformation Program ; National Industrial Development and Logistics Program ; نظرة عامة Laws and Regulations Guidelines Drugs Requirements A. Document Control Version SFDA Recognized Standards (Supporting Medical Device Premarket Submissions) 2024-05-21. Beyond these core areas, it regulates other SFDA in vision 2030 . Healthcare providers shall ensure the safe use of relevant medical device to enhance the نظرة عامة Laws and Regulations Guidelines Drugs Circulars forms Circulars FAQ Sector Committee. Article 1: scope and definitions Scope: These requirements and conditions apply to all food products imported from the exporting countries into Kingdom of Saudi Arabia. Guidance on MDMA –Significant and Non-Significant Changes (MDS-G012) 2023-01-03. Sitemap; About SFDA; Contact CEO; Ask SFDA Speaker; RSS Feed; Career; FAQ; Awards and Achievements; Riyadh, September 24, 2024, SPA -- The Saudi Food and Drug Authority (SFDA) has recently updated the "Guidelines and Requirements for Cosmetic Products Listing" to enhance consumer awareness of regulatory Protecting the community through regulations and effective controls to ensure the safety of food, drugs, medical devices, cosmetics, pesticides and feed . Novel Food General Requirements List. The meeting was held today, Monday, at the headquarters of the Jeddah Chamber of Commerce Industry (JCCI) and SFDA in vision 2030 . Also, it provides assistance to comply with the requirements of filing and maintenance of their application. Requirements of Nutritional Labeling SFDA. Vision Realization Office ; National Transformation Program ; Health Sector Transformation Program ; Practitioner Guidelines • COVID-19 Assessment report Saudi Medicinal Assessment Report – Pfizer What are the requirements for food labeling? Answer The following technical regulations are related to food labeling: SFDA. Conditions and requirements for obtaining permits for drugs , pharmaceuticals , and cosmetics products for individuals for personal use The data requirements for each application will differ, depending on the drug submission type Module 4: Non-Clinical Study Reports Generally not applicable for generic products, however some exceptions may apply. CLINICAL DATA REQUIREMENTS ACCORDING TO TYPE OF SUBMISSION Every submission to the SFDA must include a minimum supporting clinical data to ensure that the product is safe and efficacious/effective to be used in humans. 2. Authorization letter requirements: 1. SFDA Recognized Standards (Supporting Medical Device Premarket Submissions) 2024-04-29. Technical validation SDR system will validate the submission automatically after the company upload SFDA Regulations. At any point 50 mm outside the external surface of the cabinet x-ray system, the radiation emitted within a cross sectional area of 10 cm2, should not exceed an exposure of 50 µR/hr. All regulatory requirements are based on the SFDA Medical Devices Interim regulation, which are issued by Saudi Food & Drug Authority Board of Directors Decree number 1-8-1429 and dated 27 Dec 2008. Document in English. Purpose: This document aims at the following: 1. اللوائح الفنية المعتمدة في مجال الغذاء بقرار مجلس إدارة الهيئة رقم (43/9) وتاريخ 1446/03/26هـ الموافق (2024/09/29) The Drug sector in the Saudi Food & Drug Authority added recently to guidelines list the first draft of the Drug Master File Requirements for Registration of Biosimilars. 2. FD/GSO 2233 “Requirements of nutritional labeling” SFDA. 1. General 1. The data requirements for veterinary medicinal product for each application will differ, based on the type of product pharmaceutical or immunological. gov. 5. Their progress culminated in 2021 SFDA Guidelines The SFDA aims to produce clear guidelines for companies to ensure they meet the minimum requirements for product registration and minimise the number of applications that are rejected. Content of a PSUR. Vision Realization Office ; National Transformation Program ; investigational drugs regulations. In order for food processing to be safe and to ensure good SFDA in vision 2030 . regulations, stipulated that, “The SFDA shall issue requirements for inspection and Quality Management System for medical devices, which includes duties, authorities, obligations, and rights of the inspector”. 14. Food Hygienic Requirements Final Revision. in the SFDA website. Vision Realization Office ; National Transformation Program ; Health Sector Transformation Program ; Requirements for Medical Devices Marketing Authorization (MDS-REQ 1) SFDA in vision 2030 . Nov 14. Food Drugs Medical Devices. Drugs. Drug@sfda. Vision Realization Office ; National Transformation Program ; Novel Food General Requirements Novel Food General Requirements 2019-12-09. Drugs Guide. 2024-12-15. 2024 نظرة عامة Laws and Regulations Guidelines Drugs Circulars forms Circulars FAQ Sector Committee. Other News . Ensuring that the advertising materials displayed in their facilities are approved by the SFDA in accordance with “Requirements for the approval of advertising and conducting awareness or charitable campaigns of medical devices (MDS-REQ 8)”. This draft is available on the web site at : For all opinions from concerned authorities or professions. This serves as general guidance for all vaccine submissions and is not specific to Covid-19 vaccines. 8. Vision Realization Office ; National Transformation Program ; Health Sector Transformation Program ; Requirements of Importation and Re-Exportation for Radioactive Materials Used in Medical Applications (MDS SFDA in vision 2030 . As the First in the Middle East, SFDA Becomes a Member of the ICH Management Committee. 2019 REQUIREMENTS I. uywqq rrkote maatwjo arldzyz zcure uztedya zyooq tgqcur jwapw vkyg