Medical Device Sector

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Medical Device Sector

• Medical Device National Registry

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Agenda

• Introduction
• Medical Devices National Registry (MDNR)
• Purpose of MDNR
• Who Should Enroll

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Introduction
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• The MDNR is the first step towards implementing a
  comprehensive regulating system.
• It aims at obtaining a profile of the Saudi
  Arabian medical Devices industry.
• Measuring the readiness of medical devices
  establishments compliance with medical device
  regulations.

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Launching date

• MDNR launched in November 2007.
• MDNR has been developed in cooperation with
  Information Technology Directorate in SFDA.

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MDNR aims to list

• Medical Devices Establishments
• Manufacturers
• Agents Suppliers dealing with
• medical devices
• In vitro diagnostics
• Prescription eye glasses
• Contact lenses their solutions

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Medical Devices National Registry (MDNR)
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• MDNR is an enrollment scheme for medical devices
  establishments, manufacturers, agents suppliers
  in Saudi Arabia
• It is a web-based enrollment system

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Consists of two parts

• An account creation

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• 2. Requests for information pertaining to
  medical devices establishments,
  manufacturersetc including company profile,
  responsible person, medical devices particulars
  post-market details

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• MDNR is not an approval system
• Assignment of registry number does not constitute
  an admission or agreement by the SFDA

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Purpose of MDNR
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• To obtain a profile of the Saudi Arabia medical
  devices industry
• To establish a database of all establishments
  working in the field of medical devices
• To measure the readiness of medical devices
  establishments to comply with medical devices
  regulation

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Who Should Enroll?
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• Manufacturers of medical devices, in vitro
  diagnostics, prescription eye glasses, contact
  lenses their solutions.
• Exporters Importers of medical devicesetc.
• Distributors / Vendors of medical devicesetc.

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Thank You