SFDA organized in collaboration with the World Health Organization (WHO), World Health Organization regional conference associated with meeting of inter-country on design and implementation of a regulatory program for medical devices, and on the period from 11 until April 14, 2016, in Riyadh, in addition to sessions and workshops at SFDA headquarters.
The conference, which is held with Regional Office of the World Health Organization for the Eastern Mediterranean Region participation is to reach a unified approach that it will help to legalize and regulate medical devices and products with the development of joint controls on the level of the region, thus contributing to protection and guarantee public health and safety.
It also seeks to provide guidance on design and implementation of effective and reasonable cost of regulation and legislation of laws for medical devices and products of national programs, and share countries experiences on different models to define the regulatory functions of medical devices, and develop a plan to be followed when implementing the regulation of medical devices in domestic settings.
The conference will put general framework for the development and improvement of the regulatory functions of medical devices, by discussing the key concepts and elements of the medical device system in terms of difficulty, and conformity assessment, registration, and marketing licenses, inspection and monitoring of post-marketing, in addition to Saudi Arabia experience in development of regulating Medical devices.
And will work to develop a plan that can be used by Member States in various stages of development in regulation of medical devices, includes strategic objectives and adhere to policies, consumer protection controls, and marketing system licenses.
Participants in the conference are two candidates from Member States (22 countries), and they are directly related to the organization of medical devices and products in those countries.
Conference illustrates to officials and legislators Member States the importance of legalizing and regulating medical devices to improve the quality of and safety of health care services, and in particular the meeting will support the Member States in the preparation of a road map that it can be used in the design and implementation of the regulatory program for medical devices, and to identify required actions that will be taken by World health organization to provide technical support to Member States in the preparation of regulatory functions for medical devices, in addition to the development of a regional forum to discuss about the regulation of medical devices to facilitate and the exchange of knowledge and information.
Meanwhile, the Executive Vice President of medical devices and products sector , SFDA, Dr. Nazeeh Al-Othmani, said, that the main objective of the implementation of the regulatory program for medical devices is to help protect and ensure public health and safety. And to do that, it must maintain the safety, quality and performance of any medical device level throughout operating in lifetime period.
He added: "Not only that, but all establishments in the system must operate on implementation of the system in an effective and responsible way."
He stressed that this applications unless it done by some or all of the Member States of the Eastern Mediterranean to unified and regulate the medical devices and products and the development of joint controls at the regional level (as in European Union), "all this solutions will be individually designed and specific to each individual state, where the lawmakers in that state will define the difficulty of the regulatory that controls the medical devices.”