Saudi Arabia SFDA Guide for Medical
Saudi Arabia Market Access for Medical Device
REGULATORY AGENCY
- Saudi Food & Drug Authority (SFDA)
REGULATIONS
- After the 31 December 2011, only medical devices that have a SFDA marketing authorisation may be put into service within Saudi Arabia.
- ll manufacturers are required to register themselves and medical devices in the Medical Devices National Registry (MDNR) before applying for the Medical Devices Marketing Authorisation (MDMA) system.
GUIDELINES
- A local representative is required.
- SFDA will grant a written Medical Devices Marketing Authorisation to manufacturers upon approval.
APPLICABLE PRODUCT CATEGORIES
Product categories under the Interim Marketing Authorisation Regulation include:
- All medical devices and their accessories
- Contact lenses and laser surgical equipment for cosmetic rather than medical purposes, and their accessories.
△ The above picture and text are from the Internet. If there is any infringement, please contact us in time and we will delete it immediately.
As the first global market access digital platform, BWTCmall.com offers a new and unprecedented online service experience for its many users.
As a technology-driven company, BWTCmall.com is committed to developing a powerful and scalable platform that not only enables global manufacturers to quickly and accurately find the best way to reach the global market, but also to experience cost-effective cutting-edge technology and services. Let the global market access market truly enter a virtuous circle of fairness, objectivity, harmony and win-win.
Please visit the solution for get your best way of testing and certification / approvals to the target market.
