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Author: المحرر التنظيمي

Published by regulatory affairs team in PharmaKnowl, Riyadh office.
  • Signal Management Workshop (March 2023 Riyadh)

  • How to submit a PSUR to SFDA and what are the requirments?

    Periodic Safety Update Report (PSUR) Submission to SFDA

  • The new route of registration for low risk medical device

    SFDA Sunsets the MDNR Procedure for Low-Risk Medical Devices

  • Product label and artwork requirements in Saudi Arabia according to SFDA.

    SFDA Labelling Requirements (SPC, PIL, IFU, Artworks)

  • NDLP: Saudi Pharmaceutical Market is expected at $11.7 billion by 2030 (Medical Devices Included)

  • UDI services SFDA

    UDI Data Submission to SFDA for Medical Devices

  • SFDA fees and charges for applications and services.

    SFDA Fees

  • SFDA-Variation types in the guidelines

    How to Submit an SFDA Variation Application? (Guidelines V. 6.3)

  • SFDA-Classification

    SFDA Product Classification

  • SFDA GMP Manufacturer-Registration-in-Saudi-Arabia

    How to Obtain an SFDA GMP License for Pharma Manufacturers?

  • SFDA Priority Registration

    SFDA Priority Review: 40% Faster Registration

  • sfda cosmetics registration

    SFDA Cosmetics Registration

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