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Workshop - Procedures for Licensing Medical Devices Manufacturing Facilities and Technical Requirements for Obtaining a Marketing Authorization Certificate

workshop

Workshop - Procedures for Licensing Medical Devices Manufacturing Facilities and Technical Requirements for Obtaining a Marketing Authorization Certificate

5/27/24

Date
11:00am - 1:00pm
Locaton
Jeddah Chamber - Main Building - Naheda Al-Fadl Hall - Second Floor
Industrial Council

Goals

To clarify the role of the Saudi Food and Drug Authority (SFDA) in supporting local factories.

Axles

  • Legislative and regulatory framework for medical devices and supplies
  • The role of standards in supporting the medical device industry
  • Requirements for obtaining marketing authorization for medical devices and supplies
  • Technical requirements for the manufacturing pathways of medical devices and supplies
  • Basic principles of safety and performance for medical devices and supplies
  • Post-market surveillance requirements for medical devices and supplies
  • Quality management system for medical devices according to ISO 13485:2016
  • Licensing requirements for medical device and supply factories
  • Requirements for importing raw materials for manufacturing

Speakers

  • Fajr Al-Qusair
  • Eng. Thamer Al-Arawan
  • Eng. Moaz Al-Sheha
  • Eng. Firas Al-Asqa
  • Eng. Mishal Al-Aqlaa
  • Ahmed Al-Mukhtar
  • Eng. Waleed Al-Zaidi 
  • Othman Al-Shahri

Target Group

Local manufacturers of medical devices and supplies

Organizer

Jeddah Chamber

Participating Entities

Saudi Food and Drug Authority (SFDA)

To contact and inquire

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