saudi arabia e labeling medical devices

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  • Medical Device Registration in Saudi Arabia

    Professional use medical devices labeling must be provided in English, while home use medical devices labeling must be provided in Arabic. Useful information: In order to register medical devices in Saudi Arabia, authorization in at least one of the following countries is …

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  • Saudi Arabia - Medical Devices | export.gov

    2021-5-29 · Saudi Arabia - Labeling/Marking Requirements ... Saudi Arabia - Medical DevicesSaudi Arabia - Medical Devices This is a best prospect industry sector for this country. Includes a market overview and trade data. Last Published: 1/22/2020. Overview …

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  • New Saudi Food & Drug Authority medical device

    2015-2-16 · Feb 16, 2015. The Saudi Food & Drug Authority (SFDA) has issued new guidance on labeling requirements for medical devices approved for sale in the Kingdom of Saudi Arabia (KSA). The guidance clarifies labeling rules previously included in the Saudi Medical Devices Interim Regulation more so than adds any new or altered requirements.

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  • Medical device registration Saudi Arabia, KSA, SFDA ...

    In Saudi Arabia, devices are classified into 4 classes. Grouping of models, variants, accessories into a single application is accepted as per the Saudi Arabia Medical Device Regulations. For border-line products and the devices which fall under different classes in the reference countries, there is a provision for Formal classification by SFDA.

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  • Medical Device Registration in Saudi Arabia

    2020-10-14 · Medical Device Registration in Saudi Arabia. Click here to visit SFDA (Authority) website to learn more on medical device registration in Saudi Arabia. Labels to show the following: 1. The manufacturer name and address. 2. The EU representative details (name and address), for non-European manufacturer. 3.

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  • Saudi Arabia UDI Rules for Medical Devices and ...

    2019-11-12 · Saudi Unique Device Identification (UDI) SFDA, Medical Devices Sector. Nov - 2019. SAUDI-D

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  • Saudi Arabia Medical Device Regulations - Emergo by

    11 行 · 2 天前 · Introduction to Saudi Arabia's Medical Device Approval Process Saudi Arabia is one of …

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  • New guidance clarifies Saudi labeling requirements for ...

    2015-2-17 · By Stewart Eisenhart, Emergo Group The Saudi Food & Drug Authority (SFDA) has issued new guidance on labeling requirements for medical devices approved for sale in the Kingdom of Saudi Arabia …

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  • Benefits and Challenges of e-labeling for Medical

    e-labeling plays a critical role in the medical devices industry, as it ensures to improve operational efficiency, maintain brand consistency, obtain compliance and support business growth. Hence, the device industry is moving towards adopting end-to-end e-labeling life cycle procedures, starting from label content creation to review and approvals. How are they beneficial and what kind of ...

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  • Overview of e-Labeling for medical devices and IVDs

    2014-8-29 · While discussions and debate ensued regarding the comment from the Medical Devices Directive MDD 93/42/EEC, Annex I Essential Requirements (ER) that the IFU must be 'set out in the leaflet supplied,' e-labeling became more accepted with in vitro diagnostic medical devices following the publication of a guidance document in January 2007.

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  • MDS G10 - old.sfda.gov.sa

    2015-6-4 · Medical Devices National Registry is the database of both registered establishments and medical devices the SFDA has authorized to be placed on the KSA market . National Establishment Registry Number is the number issued to a person by the SFDA under the establishment registration provisions of the Medical Devices Interim Regulation.

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  • New guidance clarifies Saudi labeling requirements for ...

    2015-2-17 · By Stewart Eisenhart, Emergo Group The Saudi Food & Drug Authority (SFDA) has issued new guidance on labeling requirements for medical devices approved for sale in the Kingdom of Saudi Arabia …

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  • Medical Device, Cosmetics, License, Registration,

    Overview Being one of the effective online Regulatory systems, Saudi Arabia stands an easy-to-go-with market for medical devices, medicinal products and cosmetics’ registrations and approvals. However, the GCC’s (Gulf Cooperation Council) increasingly complex Regulatory requirements emphasize the need for manufacturers to be abreast with the rapid changes. The challenge for foreign ...

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  • SFDA Guidance for Medical Device Importers and ...

    2021-6-15 · The Saudi Food and Drug Authority (SFDA) of Saudi Arabia has published guidance for importers and distributors. The document is intended to provide additional clarifications regarding the applicable rules and requirements the parties involved in operations with medical devices shall follow.

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  • Medical Translation into Arabic | GlobalVision

    The Saudi Food & Drug Authority (SFDA) has issued new guidance on labeling requirements for medical devices approved for sale in the Kingdom of Saudi Arabia (KSA). They include medical translation requirements into Arabic. Guidance Rules. The guidance opens in a new window clarifies labeling rules previously included in the Saudi Medical ...

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  • Saudi Arabia - Prohibited and Restricted Imports

    2019-10-13 · Medical devices are subject to specific labeling guidelines. The device or the packaging, as appropriate, must be labeled with the name of the device, name and address of the manufacturer, special storage conditions, warnings and contra-indications, and batch code or lot number, along with many other requirements specific to the type of device.

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  • Saudi Arabia (KSA) - Medical Device Vigilance

    2020-6-17 · Hello everybody, I have a vigilance-related question regarding the marketing of class IIb and III devices (according to 93/42/CEE) in the Kingdom of Saudi Arabia, and I am hoping that somebody may be able to shed some light on the topic. After reading the FAQ section (“what should be reported”) of the Saudi Arabia's National Center for Medical Devices Reporting (NMCDR) website regarding ...

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  • New Regulations in Saudi Arabia | SGS

    New Regulations in Saudi Arabia. The market for medical devices in the Kingdom of Saudi Arabia (KSA) has exhibited many years of growth and is currently estimated at US3.5 billion (€2.4 billion) per year, almost all imported. As a result, the implementation of the first KSA regulations applying to the medical devices industry has global ...

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  • This table summarises the general requirements and ...

    2016-10-4 · This table summarises the general requirements and standards for food and agricultural imports into Saudi Arabia. Certification Requirements Remarks ... drugs, and medical devices inspecting imported food products at the ports of entry setting food standards and ensuring the safety of food products ... Must meet labeling requirements as ...

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  • Update to Product Labeling Requirements for Exports

    Update to Saudi Requirements for Product Labeling. Listed below are the general rules for the marking and labeling of products being exported to the Kingdom of Saudi Arabia. Exporters/Manufacturers are requested to ensure that the products they are exporting to KSA adhere to these marking requirements.

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  • MDS-G21 Guidance on Requirements of Shipments

    2020-10-20 · MDS-G10 entitled “Guidance on Labeling Requirements for Medical Devices”. 2. Devices intended to be connected to an a/c power supply and imported for marketing purpose shall operate at a frequency of 60 Hz. ... KSA Kingdom of Saudi Arabia SFDA Saudi Food and Drug Authority MDS Medical Devices Sector MOI Ministry of Interior

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  • Saudi Arabia - Trade Barriers

    2019-10-13 · Medical devices are subject to specific labeling guidelines. The device or the packaging, as appropriate, must be labeled with the name of the device, name and address of the manufacturer, special storage conditions, warnings and contra-indications, and batch code or lot number, along with many other requirements specific to the type of device.

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  • Medical Translation into Arabic | GlobalVision

    The Saudi Food & Drug Authority (SFDA) has issued new guidance on labeling requirements for medical devices approved for sale in the Kingdom of Saudi Arabia (KSA). They include medical translation requirements into Arabic. Guidance Rules. The guidance opens in a new window clarifies labeling rules previously included in the Saudi Medical ...

    Get Price
  • MDS G20 Guidance on Requirements for Clinical ...

    2020-9-10 · Labeling Requirements 6 The labeling of the device shall comply with the requirements described in SFDA’s guidance document entitled MDS – G10 Guidance on Labeling Requirements for Medical Devices Reporting of Serious Adverse Event and Device Deficiency 7 The Sponsor shall report to the SFDA’s NCMDR about any serious

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  • SASO

    2 天前 · Wednesday 31 Mar 2021 SASO & University of Hail Sign A Memorandum of Cooperation in Qualifying and Researching Services. His Excellency, Dr. Saad Bin Osman Al-Kasabi, the Governor of Saudi Standards, Metrology and Quality Organization (SASO), and His Excellency, Dr. Khalil Bin Ibrahim al-Ibrahim, the President of the University of Hail signed a memorandum to enhance the mutual …

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  • Importing Products to Saudi Arabia: A Complete Guide

    2020-1-14 · Saudi Arabia has signed a number of trade agreements within the Gulf Cooperation Council (GCC) that gives member countries total exemption from customs duties (e.g. a zero percentage rate is applied). In addition to the member countries of GCC, Saudi Arabia also has a preferential policy that reduces customs duty to 10% on products imported from several Islamic countries, including Morocco ...

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  • Saudi Arabia (KSA) - Medical Device Vigilance

    2020-6-17 · Hello everybody, I have a vigilance-related question regarding the marketing of class IIb and III devices (according to 93/42/CEE) in the Kingdom of Saudi Arabia, and I am hoping that somebody may be able to shed some light on the topic. After reading the FAQ section (“what should be reported”) of the Saudi Arabia's National Center for Medical Devices Reporting (NMCDR) website regarding ...

    Get Price
  • FDA Issues Final Guidance on Medical Devices in the

    2021-5-21 · May 21, 2021 — The U.S. Food and Drug Administration (FDA) issued this final guidance: Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.This guidance document provides the FDA’s recommendations on testing to assess the safety and compatibility of medical devices in the MR environment and the recommended format for magnetic …

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  • Unique Device Identification (UDI) - Healthcare | GS1

    2021-6-15 · The EU Medical Device Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR) were adopted on 5 April 2017 and define the requirements for the EU UDI system. On 7 June 2019, GS1 was designated by the European Commission as an issuing entity for Unique Device Identifiers (UDIs). GS1 standards are enabling healthcare manufacturers from around ...

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  • Russia Medical Device Regulations| TÜV SÜD

    The approval of medical devices in Russia is divided into two steps: registration at the state authority and declaration of conformity at the accredited certification body. A declaration of conformity has replaced the GOST-R certificate for most medical devices.

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  • MDS-G21 Guidance on Requirements of Shipments

    2020-10-20 · MDS-G10 entitled “Guidance on Labeling Requirements for Medical Devices”. 2. Devices intended to be connected to an a/c power supply and imported for marketing purpose shall operate at a frequency of 60 Hz. ... KSA Kingdom of Saudi Arabia SFDA Saudi Food and Drug Authority MDS Medical Devices Sector MOI Ministry of Interior

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  • Healthcare Resource Guide: Saudi Arabia - Export.gov

    The General Authority of Zakat & Tax has exempted medicine and medical devices from the VAT for “only those items that are specified/procured by the Ministry of Health and the Saudi Food and Drug Authority.” Shipping: Saudi Arabia gives preference to national carriers for up to 40% of government-related cargos. Two local companies take full ...

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  • Healthcare Resource Guide: Saudi Arabia - Export.gov

    2015-11-18 · The Saudi health care sector is still the largest in the Near East North Africa; the latest available figures indicate that the Saudi market for medical devices stood at 1.72 billion in 2013, and was expected to have reached 1.88 billion in 2014, more than nine percent average annual growth.

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  • Importing Products to Saudi Arabia: A Complete Guide

    2020-1-14 · Saudi Arabia has signed a number of trade agreements within the Gulf Cooperation Council (GCC) that gives member countries total exemption from customs duties (e.g. a zero percentage rate is applied). In addition to the member countries of GCC, Saudi Arabia also has a preferential policy that reduces customs duty to 10% on products imported from several Islamic countries, including Morocco ...

    Get Price
  • FDA to Amend Labeling Requirements for Medical

    On June 15, 2016, the Food and Drug Administration (FDA) published a final rule, 81 FR 38911, Use of Symbols in Labeling. The final rule revises FDA labeling requirements of medical devices and certain biological products concerning the inclusion of symbols or graphical representations of information. Read the full update here.

    Get Price
  • Cosmetic and Food Certification for Saudi Arabia |

    The Saudi Food & Drugs Authority (SFDA) has appointed TÜV Rheinland as a notified body. As such, we issue Certificates of Conformity for food & cosmetic products consignments exported from specific countries to the Kingdom of Saudi Arabia Market and in order to safeguard consumers. Relevant products have to be in compliance with specific SFDA ...

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  • Saudi Arabia - ECommerce | export.gov

    2021-6-14 · Saudi Arabia - ECommerceSaudi Arabia - ECommerce Describes how widely e-Commerce is used, the primary sectors that sell through e-commerce, and how much product/service in each sector is sold through e-commerce versus brick-and-mortar retail.

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  • Russia Medical Device Regulations| TÜV SÜD

    The approval of medical devices in Russia is divided into two steps: registration at the state authority and declaration of conformity at the accredited certification body. A declaration of conformity has replaced the GOST-R certificate for most medical devices.

    Get Price
  • Medical Devices Packaging Market | Growth, Trends,

    The medical devices packaging market was valued at USD 29.32 billion in 2020 and expected to reach USD 41.91 billion by 2026 and grow at a CAGR of 6.13% over the forecast period (2021-2026). The healthcare industry has evolved from its erstwhile traditional form of practices to the current position, where high-tech equipment and instruments are ...

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  • Medical device registration in Israel - Thema Med

    Labeling and documentation language: The following documentation must be submitted in Hebrew. Some official certification documents, for example, do not need to be translated if they are in English. In case the medical device is intended for domestic use, the labeling and instructions for use must be provided in English, Hebrew and Arabic.

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  • MDS-G34 Guidance on Requirements for Unique Device ...

    2020-9-10 · D. Saudi Arabia UDI Database - (Saudi-DI) 1. The manufacturer, or its authorized representative, shall submit and maintain the appropriate data to the (Saudi-DI) database for all devices subject to this guidance. 2. The manufacturer, or its authorized representative, shall validate UDI data during submission process also on an annual basis 3.

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  • Saudi FDA Products Classification Guidance

    2021-4-25 · Saudi Food & Drug Authority Vision and Mission ةلاسرلاو ةيؤرلا Vision To be the leading regional regulatory authority for food, drugs and medical devices with professional and excellent services that contributes to the protection and advancement of the health in Saudi Arabia. ةيؤرلا

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  • Saudi UDI Expectations and Barcode Requirements

    2016-4-28 · Medical devices may be placed on the market and/or put into service only if they comply with the applicable provisions of the Interim Regulation as signified by the SFDA issuing the manufacturer with a writtenMarketingAuthorization.(ChapterTwo,ArticleFour,MDIR) To obtain marketing authorisation, medical devices shall comply with the

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  • Healthcare Resource Guide: Saudi Arabia - Export.gov

    2015-11-18 · The Saudi health care sector is still the largest in the Near East North Africa; the latest available figures indicate that the Saudi market for medical devices stood at 1.72 billion in 2013, and was expected to have reached 1.88 billion in 2014, more than nine percent average annual growth.

    Get Price
  • FDA to Amend Labeling Requirements for Medical

    On June 15, 2016, the Food and Drug Administration (FDA) published a final rule, 81 FR 38911, Use of Symbols in Labeling. The final rule revises FDA labeling requirements of medical devices and certain biological products concerning the inclusion of symbols or graphical representations of information. Read the full update here.

    Get Price
  • Medical Device Marking: Challenges and Solutions

    2021-6-11 · Whitepaper Medical Device Marking . Marking medical devices can be challenging for medical device manufacturers. Identification tasks become increasingly demanding and the industry's regulations are getting stricter, such as currently shown by the FDA's (Food and Drug Association) UDI (Unique Device Identification) directive.

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  • Labeling Machines & Tapes at Jarir Bookstore

    Shop for Arabic & English books, Jarir publications books, office supplies, school supplies, arts & crafts supplies, children development, computers & peripherals, computer supplies, smartphones & electronics, Roco products, and video games at Jarir Bookstore.

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  • Saudi Arabia - Standards for Trade

    2019-10-13 · Saudi Arabia’s residential electric power system of 127/220 volts, 60 hertz, is unique and has caused export problems for many American firms. However, SASO will accept electrical products as low as 120 volts, 60 hertz. The SAG is moving to make 220 volts the only accepted standard.

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  • Download a Medical Device company labeling Case

    This Medical Devices Company was facing challenges with facilitating foreign language translation, streamlining the label approval process, achieving compliance with global regulations and reducing label errors. The NiceLabel Enterprise Platform allowed them to: Create multi-lingual and UDI compliant labels. Reduce label templates by hundreds.

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  • Slovenia Medical Device Registration - JAZMP

    In Slovenia, devices are regulated by the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP). CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb and III. TIMEFRAME: The registration process takes about 4-6 weeks after submission for Class I devices.

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