Riyadh, Saudi Arabia

info@unifusion-bsc.com

+966557696888

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Saudi Regulatory Consultant
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Connecting Global Manufacturers with Licensed Saudi Distributors 

Through our top-tier partners within the Kingdom of Saudi Arabia, we can connect you with a well-established network of licensed distributors who are actively engaged in the healthcare sector, including medical devices, in vitro diagnostics (IVDs), and pharmaceutical products. These partners have a proven track record and are strategically positioned to support the local promotion, sales, and distribution of your products. 

Our team at Unifusion B.S.C. is well-versed in the regulatory and commercial landscape of Saudi Arabia. We offer end-to-end support, beginning with the selection and qualification of distributors, to handling the full importation process, ensuring that all documentation and regulatory requirements are met in accordance with Saudi Food and Drug Authority (SFDA) regulations. 

For medical devices and IVDs, we can assist in obtaining MDMA/IVDMA approvals, linking authorized representatives, and ensuring compliance with labeling, UDI, and post-market surveillance obligations. For pharmaceutical and drug products, we help ensure proper product classification, registration in the Drug Registration System (DRS), pricing submission, and support in securing import permits and distribution rights through SFDA-licensed wholesalers. 

By leveraging our strong relationships within the Kingdom, we aim to streamline your market entry process and help position your products for long-term success in one of the most dynamic and regulated healthcare markets in the region. 

UniFusion
  • About UniFusion
  • Our Values
  • Why UniFusion
  • Clients
  • News
  • Success Stories
  • Contact Us
Core Services
  • MDs & IVDs Registration
  • UDI Submission
  • Drugs Registration
  • Cosmetics Registration
  • Product Classification
  • Distribution Solutions
  • Localization Support
  • Expert Consulting
ISO Services
  • ISO 13485
  • ISO 9001
  • ISO 21001
  • ISO 22483
  • ISO 18788
  • IATF 16949
Resources
  • Regulatory Guidance
  • Webinars
  • Newsletter
  • Company Brochure

Riyadh, Saudi Arabia

info@unifusion-bsc.com

+966557696888

  • Follow us

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