The Medical Devices Interim Regulation

Introduction

Saudi Food and Drug Authority (SFDA) was established under the Council of Ministers resolution no. (1) Issued on 10/3/2003, as an independent Authority reporting to the Council of Ministers. The SFDA aims to "ensure the safety of food, safety, quality and effectiveness of drug, and the safety, quality, effectiveness and performance of medical devices according to their intended purpose. Regulating medical devices, in vitro- diagnostic devices, prescription eye glasses, contact lenses and their solutions, are among the responsibilities of SFDA in accordance with its law issued by the royal decree No.(M/6) issued on 13/2/2007. Based on the Council of Ministers resolution no. (181) issued on 18/6/2007, that gave SFDA the right to issue regulations for medical devices registration rules and procedures, the SFDA issued a medical devices interim regulation, which was adopted by SFDA board of director’s decision no. (1-8-1429) issued on 27/12/2008. This regulation will apply until the medical devices comprehensive law is approved.

As a result the SFDA launched a comprehensive marketing authorization program intended to safeguard public health as it relates to medical devices. The program comprises two major steps.

  • Establish an overall profile of the medical devices presently on the Kingdom of Saudi Arabia (KSA) market.

  • Develop, adopt and apply a Medical Devices Interim Regulation, complemented by Implementing Rules, thereby ensuring legal certainty that only medical devices that have been authorized by one of the Founding Members of the Global Harmonization Task Force (GHTF) have access to the KSA market.

A. First Steps

  • The SFDA has launched the Medical Devices National Registry (MDNR) for the purpose of obtaining a profile of the KSA medical device industry and establishing a database of all establishments, manufacturers, agents, and suppliers working in the field of medical devices. Enrolment is through the SFDA’s internet site, with a registrant providing information on its role (e.g. local Manufacturer, Importer, and Distributer), the name of a responsible person, particulars of the medical devices with which they are involved (e.g. manufacturer’s details, country of origin, its identification code, any pre-market approval and, where applicable, post-market activities).

  • SFDA has launched a Medical Device Establishment Licensing System (MDEL) for establishments presently involved in importation and/or distribution of medical devices on the Saudi market. The applicant has to be registered in the Medical Devices National Registry (MDNR) and shall ensure that it is able to manage appropriately the imported and/or distributed devices in relation to storage, transport, traceability, installation and the like.

  •  SFDA has established the National Center for Medical Devices Reporting (NCMDR) to record, analyze and manage medical device recalls and adverse events occurring with devices during their use. The main objective is to reduce the likelihood of occurrence of incidents and/or to prevent repetition of adverse events. Authorized representatives, manufacturers, importers, distributors and users are expected to inform the SFDA about any device recalls or adverse events of which they are aware. The reports will be analyzed and appropriate action shall be taken. This process applies to all medical devices placed on the market and/or in use within the KSA.

B. The Interim Regulatory Scheme .

The interim regulatory scheme comprises the Medical Devices Interim Regulation issued by the Saudi Food and Drug Authority Board of Directors together with eight Implementing Rules adopted by the SFDA/MDS.

  • The Interim Regulation Decree number 1-8-1429 is dated 27th December 2008 was published in Umm Al-Qura Journal year 86 Issue No 4249 dated 17th April 2009. It stipulates the overall framework of the regulatory approach to allow only those medical devices that have been authorized by the SFDA to be placed on the KSA market, to ensure organizations involved in importation and distribution activities are registered with the SFDA, to ensure authorized representatives acting on behalf of overseas manufacturers are registered with the SFDA, and specify appropriate post-marketing surveillance activities.

  • Eight Implementing Rules, have been adopted by the SFDA/MDS to specify and refine the provisions of the Interim Regulation. As required by Article Forty Three of the Medical Devices Interim Regulation, each Implementing Rule specifies its application date and the application date of the provisions of the Medical Devices Interim Regulation to which it relates.

With respect to medical devices marketing authorization, Implementing Rule MDS-IR 6 specifies a six month transitional period allowing the progressive placing on the Saudi market of medical devices authorized by the SFDA. From 14th February 2011 any medical device that has obtained an SFDA marketing authorization may be placed on the Saudi market. Medical devices which are presently allowed on the KSA market may continue to be placed on the market, however, after 14th August2011 only medical devices with an SFDA marketing authorization may be placed on the market. After 31st December 2011 only medical devices with an SFDA marketing authorization may be put into service within the KSA, while devices in use at that date may continue to be utilized.