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

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

خدمة البث المباشر للمناسبة ستكون متاحة في حال تم الإعلان عنها في قنوات التواصل الإجتماعي

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