Medical Device Sector

1. Medical Device Sector Medical Device National Registry

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

3. Introduction

4. 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.

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

6. MDNR aims to list : Medical Devices Establishments Manufacturers Agents & Suppliers dealing with medical devices In vitro diagnostics Prescription eye glasses Contact lenses & their solutions

7. Medical Devices National Registry (MDNR)

8. MDNR is an enrollment scheme for medical devices establishments, manufacturers, agents & suppliers in Saudi Arabia • It is a web-based enrollment system

9. Consists of two parts : An account creation

10. 2. Requests for information pertaining to medical devices establishments, manufacturers…etc including company profile, responsible person, medical devices particulars & post-market details

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

16. Purpose of MDNR

17. 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

18. Who Should Enroll?

19. Manufacturers of medical devices, in vitro diagnostics, prescription eye glasses, contact lenses & their solutions. • Exporters & Importers of medical devices…etc. • Distributors / Vendors of medical devices…etc.

20. Thank You