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Guidance on Medical Devices Classification (MDS – G008)

    https://sfda.gov.sa/en/regulations/65997
    SFDA in vision 2030 . Vision Realization Office ; National Transformation Program ; ... Guidance on Medical Devices Classification (MDS – G008) Guidance on Medical Devices Classification (MDS – G008) 2022-12-13. Guidance on Medical …

Product Classification - Food and Drug Administration

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm

    Medical Devices | Saudi Food and Drug Authority - SFDA

      https://www.sfda.gov.sa/en/node/66119
      Medical Devices. - SFDA list of Authorized Medical Devices for COVID-19 (EUA and MDMA) . - Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic. - …

    Medical Devices Classification System - SFDA

      https://pcs.sfda.gov.sa/FAQen.aspx
      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 …

    Product Classification System - SFDA

      http://pcs.sfda.gov.sa/
      © 2014 , All rights reserved, Saudi Food and Drug Authority | Terms of UseTerms of Use

    "SFDA" launches classification system for …

      https://sfda.gov.sa/en/news/426
      SFDA launched classification for medical devices and products system (MDC), which aims to facilitate and accelerate the procedures in categorization received transactions for medical …

    SFDA Classification Guidelines (2022 Updates Explained)

      https://pharmaknowl.com/sfda-product-classification/
      The classification decision is based on scientific grounds and regulations related to labelling, claims, and ingredients. A famous late example is the hyaluronic acid …

    Medical Equipment List | Saudi Food and Drug Authority

      https://www.sfda.gov.sa/en/medical-equipment-list
      Details. STA Single Tooth Anesthesia System Computer Controlled Local Anesthetic Delivery (C-CLAD) Drive Unit. Class IIa. مصنع مها طالب عبدالله السعدون للصناعة. Active. Details. The …

    SFDA Medical Device Registration

      https://pharmaknowl.com/sfda-medical-devices-registration-saudi-arabia/
      The Saudi Food and Drug Authority (SFDA) has extensively updated the medical device regulations in Saudi Arabia. Mainly between 2019 and 2022, which increased the complexity of …

    Provisions for Medical Device Classification - SFDA

      http://www.sfda.com/provisions-for-medical-device-classification.html
      Article 8 The terms used in the provisions are defined as follows: 1. Intended purpose: the desired effect of a medical device that is illustrated in its product specification, label or …



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