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 ( Click Here ).

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, summarized in Section B1 below, 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.

B.1 . Implementing Rules

Implementing Rule on Designation and Oversight of Conformity Assessment Bodies (MDS-IR1) ( Click Here ).

This Implementing Rule specifies and refines the provisions of CHAPTER SEVEN of the Medical Devices Interim Regulation. While retaining in full the responsibilities placed upon it by the regulations, the SFDA may designate third-party organizations, known as Conformity Assessment Bodies (CABs), to assist it in carrying out the duties specified in CHAPTERS TWO and SIX of the Medical Device Interim Regulation, and its Implementing Rule MDS-IR6.

Implementing Rule on Establishment Registration (MDS-IR2) ( Click Here )

This Implementing Rule specifies and refines the provisions of CHAPTERS THREE and FOUR of the Medical Device Interim Regulation. Local manufactures, authorized representatives, importers and distributers involved in the supply of SFDA authorized medical devices shall register their establishments with the SFDA’s Medical Device National Registry (MDNR). They shall submit the information specified in Article Eight of Implementing Rule MDS–IR2 before they place such medical devices on the KSA market. SFDA will assign an establishment National Registry Number to each registrant. 

Implementing Rule on Medical Devices Listing (MDS-IR3) ( Click Here ).

This Implementing Rule specifies and refines the provisions of CHAPTERS THREE and FOUR of the Medical Devices Interim Regulation. Local manufacturers, authorized representatives, importers and distributers involved in the supply of SFDA authorized medical devices shall list the devices they intend to place on the Saudi market with the SFDA’s Medical Device National Registry (MDNR). They shall submit the information specified in Article Eight of Implementing Rule MDS-IR3 when they supply such medical devices to the KSA market. SFDA will assign a Listing National Registry Number to each medical device listed in the database.

Implementing Rule on Establishment Licensing (MDS-IR4) ( Click Here ).

This Implementing Rule specifies and refines the provisions of CHAPTER FIVE of the Medical Devices Interim Regulation. Organizations involved in the importation and/or the distribution of SFDA authorized medical devices into or within the KSA shall have an establishment license for each activity issued by the SFDA before supplying devices. They shall submit the information specified in respectively Articles Seven and Twelve of Implementing Rule MDS-IR4 in due time ( see electronic form MDELS ). SFDA will issue the applicant with an establishment license for its requested activity(ies), when it is satisfied that the relevant requirements have been met.

Implementing Rule on Licensing of Authorized Representatives (MDS-IR5) ( Click Here

This Implementing Rule specifies and refines the provisions of CHAPTER SIX of the Medical Devices Interim Regulation. Manufacturers not established in the KSA shall designate an organization authorized by it to act on his behalf in the KSA. This authorized representative shall introduce an application with the SFDA and declare to perform the activities specified in Article Six of Implementing Rule MDS-IR5 ( see electronic form MDELS ). SFDA will issue the authorized representative with an establishment License, when it is satisfied that the relevant requirements have been met.

Implementing Rule on Marketing Authorization (MDS-IR6) ( Click Here ). 

This Implementing Rule specifies and refines the provisions of CHAPTERS TWO and SIX of the Medical Devices Interim Regulation.Manufacturers wishing to supply a Medical Device in the KSA shall provide the SFDA with documentation that demonstrates that the device is authorized to be placed on the market in one of the GHTF Founding Member jurisdictions and that it complies with the specific Saudi requirements specified in the Medical Device Interim Regulation and Article Five of Implementing Rule MDS-IR6 ( see electronic form MDMA ). SFDA shall issue a marketing authorization in writing to the manufacturer, when it is satisfied that the relevant requirements have been met.

Implementing Rule on Post-Marketing Surveillance (MDS-IR7) ( Click Here ).

This Implementing Rule specifies and refines the provisions of CHAPTERS EIGHT and TEN of the Medical Devices Interim Regulation. SFDA shall take all appropriate measures, within its power, to ensure that SFDA authorized medical devices are subject to post-marketing surveillance, comprising device adverse event management (CHAPTER TWO) and market control (CHAPTER THREE). All parties concerned shall be made aware of their responsibilities and obligations.

Implementing Rule on Safeguard Procedures (MDS-IR8) ( Click Here ).

This Implementing Rule specifies and refines the provisions of CHAPTER NINE of the Medical Devices Interim Regulation (MDIR). SFDA requires that measures are taken to remove any threat to public health that may be caused by medical devices available on the KSA market which do not comply with the Medical Devices Interim Regulation and its relevant Implementation Rules. Where appropriate, SFDA shall take safeguard actions against these devices and inform the authorizing GHTF Competent Authorities concerned. 

National Provisions and Requirements for Medical Devices ( Click Here ).

This document shall provide the National Requirements to be applied for Medical Devices for inpatient, outpatient and home health care settings. All rules and regulations published by the Saudi Food & Drug Authority- Medical Devices Sector shall be applied and adopted in part in this document.

B.2. Guidance Documents ( Click Here ).

The SFDA-MDS has also adopted the guidance documents, - enumerated below , to ensure a coherent and uniform application of the Implementing Rules:

1- Guidance for Medical Devices Importers and Distributers

2- Guidance for Local Manufacturers

3- Guidance for Medical Device Authorised Representatives

4- Guidance for Overseas Manufacturers

5- Guidance on Marketing Authorization Procedures

6- Implementing Rule on Post-Marketing Surveillanc

B.3. Application Fees and Review Times ( Click Here ).