Kingdom of Saudi Arabia – Operon Strategist

The Kingdom of Saudi Arabia is one of the largest markets for medical devices and associated products in the Middle East region. As part of the Gulf Cooperation Council (GCC, also known as the economic union of the six Arab states), Saudi Arabia has experienced extraordinary growth, primarily due to its hydrocarbon-based economy.

In Saudi Arabia, the Saudi Food & Drug Authority (SFDA) is the government agency that regulates drugs and medical devices in Saudi Arabia. The Medical Device Sector has three responsibilities: legislative, executive, and surveillance. As to the first, the sub-agency sets mandatory specifications for medical devices, IVDs, and radiation-emitting electronic devices; set good manufacture practices; issues policies and procedures for medical device testing; set requirements for medical devices marketing and distribution, and provides advertising regulations. The Saudi Food & Drug Authority’s objective is to ensure the safety of food and drug for man and animal, and safety of biological and chemical substance as well as electronic products. The main purpose of the Saudi Food and Drug Authority establishment is to regulate, oversee, and control food, drug, medical devices, as well as to set mandatory standard specifications thereof, whether they are imported or locally manufactured. The control and/or testing activities can be conducted in the SFDA or other agency’s laboratories. Moreover, the SFDA is in charge of consumers’ awareness of all matters related to food, drug, and medical devices and all other products and supplies.

FDA 510 k Clearance & Premarket Approval for Medical Device

Operon Strategist is FDA 510 k process consultant helps the clients to register SBU (Small Business Unit), if applicable. Take out the testing requirement of the product, creation of the dossier, resolving the queries and after completion of all the activities.

Contact UsWhatsApp

SFDA has issued a number of guidelines to assist an organization operating in the field of medical devices to understand its obligations under the Interim Regulation and the Implementing Rules.

The Saudi Food and Drug Authority seeks to achieve the kingdom of Saudi Arabia 2030 vision by enhancing efficiency and transparency and set up the necessary environment for the Saudi Community and business sector to endure their responsibilities. In addition, take the lead in facing challenges and grab opportunities, which will ensure the food safety, safety, quality and effectiveness of the drug, and the safety and efficiency of medical devices and products. This all was discussed in the recent conference named “Saudi Food and Drug Authority Second Annual Conference” which was held on 25^th – 27^th September 2018, Saudi Arabia

Saudi Food & Drug Authority Second Annual Conference Objectives Are As Follows:

• Serves as an annual gathering connects SFDA with other stakeholders from the private and public sectors.
• Exchange professional and scientific experiences with SFDA partners from the public and private sector.
• Share up-to-date best practices in regulatory sciences and other relevant disciplines.
• Transfer experiences and enhance knowledge concerning drug, food, medical devices awareness, and health promotion.
• Conduct applied workshops addressing professional and scientific aspects.
• Arranging for an annual exhibition in collaboration with SFDA partners to demonstrate the updated regulatory sciences and related tools.

Medical Devices Topics Were Discussed On:

• Clinical evaluations & investigations for medical devices.
• Medical device regulation.
• Medical devices post market surveillance and vigilance.
• Medical devices testing and calibration.
• Impact of medical device regulation.
• Cyber Security for medical devices.