Workshop - Procedures for Licensing Medical Devices Manufacturing Facilities and Technical Requirements for Obtaining a Marketing Authorization Certificate - JCC
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Jeddah Chamber
About the Chamber
Board of Directors
The Chamber's History
Work with Us
The City of Jeddah
About the Chamber
Board of Directors
The Chamber's History
Work with Us
The City of Jeddah
- Subscriber Services
Subscriber Services
Subscription Services
Approval Services
Commercial Services
Legal Services
Sectorial Councils’ Services
Saudi Business Boards
Commercial Delegation Services
Opportunities and Investment Ideas
Data Request Services
Partnerships and Suppliers Services
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Approval Services
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Legal Services
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Small and Medium Enterprises Support Center Programs
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Basta Market - Season Seven
Jeddah Moves - Season 2
- Circulars and Publications
Circulars and Publications
Circulars
Publications
Reports and Information
Circulars
Publications
Reports and Information
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Added Value Projects
Warehouse City
Exhibition and Events Center
Jeddah International Business Center
Warehouse City
Exhibition and Events Center
Jeddah International Business Center
workshop
Workshop - Procedures for Licensing Medical Devices Manufacturing Facilities and Technical Requirements for Obtaining a Marketing Authorization Certificate
5/27/24
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)
Updates to the Contractor and Engineering Offices Classification System and Mechanism
Jeddah Chamber - Main Building – Al Juffali Hall - 1st Floor
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