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SFDA Head: “We have gone far in the field of regulations and control of medical devices”

2016-05-17


His Excellency the Chief executive Officer of SFDA, Prof. Mohammed bin Abdul Rahman Almishal, confirmed that SFDA has gone far in the field of regulations and control of medical devices, pointing out to the significant growth of demand on medical devices and products in the Kingdom of Saudi Arabia at the rate of 10% annually.
 Prof. Almishal said today ‘Monday’ during opening WHO Regional Conference associated with the world health organization inter-country meeting on designing and implementing a regulatory program of medical devices: “ I am pleased to welcome you in the WHO Regional Conference associated with the world health organization inter-country meeting, Organized by SFDA in cooperation with WHO and in line with the keenness of the Custodian of the Two Holy Mosques, King Salman bin Abdul Aziz and Crown Prince, Chairman of SFDA Board and their directions to SFDA towards taking care of citizens and residents safety and health.
He added:” The state has assigned an important role to SFDA, as a legislative, regulatory and control body in the field of food, drug and medical device & products field in order to enhance and protect the public health in the Kingdom. through implementing the requirements, procedures and conditions that guarantee safety and protection of citizens, residents, patients, operators, users and all associated parties health.
His Excellency pointed out that SFDA has gone far towards regulation and control of medical devices and has endeavored to keep pace with the international regulations in this field.
Prof. Almishal referred to the increasing growth of healthcare organizations, hospitals, public & private medical centers during the last few years. The number of hospitals reached 390 with capacity of over 54000 beds, 2037 primary health centers, 175 kidney centers and approximately 217 private medical centers. This resulted in a significant growth of demand for medical devices and products which reached 10% per year. This has resulted in a larger role of SFDA towards regulation of entry, release and marketing authorization  and them monitoring of the medical devices and products in the local markets after marketing. This included reporting and recall of such devices and products if needed in order to guarantee safety of any one dealing with these devices and products.
His Excellency said he is pleased to host international experts and professional speakers in the field of regulation of medical devices from 22 states in the region to establish control of medical devices & products regulations.
He pointed out that the purpose of the conference is to view the outstanding international experience in the field of control of medical devices and to present the Kingdom’s experience in the field of medical devices regulation and control in order to come jup with a road map and action plan that enables participating states to establish their control regulations imitating the Kingdom’s experience. He thanked all participating guests. Organizing committees and participants and the regional WHO Office for their continuous and fruitful cooperation.
Prof. Almishal looked forward that the conference would come up with specific recommendations to contribute to the development of policies and legislations in the respective countries that help to design and implement a regulatory program for medical devices to realize safety and protection of the lives of patients or workers from dangers.
The conference activities started with the first session entitled: ” Medical Devices Policies on Regulation, Assessment and Management Bodies- Management & Assessment” Chaired by Dr. Nazeeh Al Othmany- VP for Medical Devices & Products – SFDA.
Engineer Adriana Vasquez of WHO delivered a paper entitled:” Success elements of Medical Devices Policies”. Dr. Adham Ismail of WHO/EMRO, presented a paper about assessment of health technologies as a tool of decision making in the field of health. Engineer Kamel Abdul Raheem of WHO/IRQ addressed ‘Improving quality, access and use of medical devices through efficient management programs”.
In Session 2- Medical Devices Regulatory Frameworks Chaired by DR. Marthe Everard- WHO/EMRO, Dr. Nazeeh Al Othmany- VP for Medical Devices & Products Sector-SFDA, presented a paper entitled: “Overview of Medical Devices & Products Regulatory Framework in Saudi Arabia” wherein he addressed SFDA  medical devices % products control Regulations, procedures and national requirements and guides in this field. He pointed out that the purpose of these regulations and legislation is to protect the public health in the Kingdom,
Mrs Joanna Koh, consultant , AHWPTC reviewed Medical Devices Regulatory Framework across Asia.
Mrs Josee Hansen, WHO/HQ addressed Global Medical Devices Regulatory Framework.Session 3 : Medical Devices Regulatory Program was chaired by Eng Ali Al-Dalaan, executive director of radiology safety department – SFDA.
Mr.Alan Kent , Consultant, UK , reviewed Step-by-Step Implementation of Medical Devices Regulatory Programs in Countries. Eng Abdullah AL-Dobaib, Executive director registration and licenses department – SFDA addressed the Development of Medical Devices Regulatory Programs in countries and SFDA experience in this field

 


 





 

 

Medical Devices