Experts from 22 countries discussed during the 2nd day of World Health Organization Inter-Country Meeting on designing and implementing, SFDA experience in regulation and control of medical devices and products

The 2nd day of the conference organized by SFDA in coordination with WHO started with session 4 chaired by Josee Hansen, entitled Overview of Pre-Market Regulatory Controls.

The executive director of pre marketing and scientific assessment department of SFDA, Mr.Meshal bin Abdurrahman Al-Amri presented a paper entitled : (Pre-Marketing Regulatory Controls in Saudi Arabia ) wherein he referred to the pre-marketing Regulatory Controls to ensure complaints to SFDA regulations.

This include registration and licensing of organizations, authorized representatives and requirements of marketing authorization of medical devices (Eg. Classifications and clinical studies).

He referred and pointed out that SFDA is keen to ensure safety and efficiency of the medical device or product. This can be proved through complaints to the Saudi, Regional and International specifications adopted by SFDA regulations. This is to improve quality and safety standards of medical devices and products and to regulate and facilitate their entry to the Saudi Market.

Mr. Paul Lovell , UL LLC, expert addressed key updates to European Union ( EU ) medical devices on pre-market regulatory controls while Peter Kaars-Wiele (Abbott Diagnostics ) addressed pre market regulatory controls from manufacturer point of view.

Eng Abdullah Al-Rasheed  Chaired the 5th sessions entitled : ( Overview of Post-Market Regulatory Controls) wherein the executive director of control and biometrics of medical devices and products department Eng Essam Al Mohandis,SFDA presented a paper entitled ( Post-Market Regulatory Controls in Saudi Arabia) while Douglas Mclvor from BSI Healthcare Saudi Arabia spoke about the elements of effective Post-Market Surveillance (PMS) Strategy. Ojaz Zatakia ( Philips) addressed Industry prespectives on post-market regulatory controls.

Session 6 was held at 2:00 Pm entitled : ( Special Topics in Medical Devices Regulation) and chaired by : Eng Adriana Velazquez, WHO wherein Mr.Mohammed Alhayan, Director of Surveillance participated by a paper entitled : ( Reprocessing of Single Use of SUD and associated hazards). Mr. Alhayan numerated the ways through which the use of a medical device would affect the properties and classification of that device. He also addressed the transformation of multi-use device into SUDs and how to process and key reasons to process used SUDs and associated risks and the studies conducted by SFDA in this field. Eng Mr. Jeffery Nelson from Nelson Laboratories Inc. presented a paper on Testing, Inspection and Verification. While Dr. Danielle Giroud, World Medical Device Organization (WMDO) addressed the Clinical Evaluation of Medical Devices and Clinical Trials Oversight (CTO).

His Excellency the Chief executive Officer of SFDA, Prof. Mohammed bin Abdul Rahman Almishal. Confirmed yesterday during opening the conference that SFDA has gone far in the field of medical devices regulation and control.

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.

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.