New Regulations in Saudi Arabia
The market for medical devices in the Kingdom of Saudi Arabia (KSA) has exhibited many years of growth and is currently estimated at US$3.5 billion (€2.4 billion) per year, almost all imported. As a result, the implementation of the first KSA regulations applying to the medical devices industry has global significance.
Previously there were no restrictions on the importation and sale of medical devices, although the Gulf Co-operation Council (GCC) audited some manufacturers as an entry requirement for large state-funded tenders.
In 2009, the medical devices sector of the Saudi Food and Drug Authority (SFDA) published the Medical Devices Interim Regulations. These included implementation dates, now amended to August 14 and December 31, 2011 (as described later). Despite the Interim title, the expectation is that these regulations will be in place for at least 5 years. They impose requirements on importers, distributors, authorized representatives, overseas manufacturers and local manufacturers. This article summarizes these regulations, focusing on those affecting overseas manufacturers.
The KSA Interim Regulations use the recognition of existing Global Harmonization Task Force (GHTF) approvals. They are based on the GHTF requirements of Europe, USA, Canada, Japan and Australia so many basic features are familiar to medical device manufacturers.
Scope of Regulations
The Regulations have adopted the global definition of a medical device, with wording similar to the GHTF/EC/Australian/Canadian text. In the KSA, active implantable, general and in vitro diagnostic medical devices and their accessories are included in this one regulation. Additionally, contact lenses and lasers used for cosmetic purposes are included. The regulations do not apply to equipment already in use but will eventually apply to unused stock within the KSA.
Requirements on KSA Operators
A web-based Medical Devices National Registry (MDNR) has been established as a result of the Interim Regulations. This includes establishment and medical device registration and listings. Within the MDNR, all KSA importers, distributors, authorized representatives and local manufacturers must be KSA legal entities and obtain an establishment license for their appropriate operations. Each of these operations is seen as a separate process, for example an authorized representative may or may not also be the importer or distributor of a device. Overseas manufacturers may wish to check that their KSA partners have obtained the necessary licenses.
Authorized Representatives needed
All overseas manufacturers must appoint a KSA Authorized Representative (AR). This AR undertakes all the duties under the Interim Regulations on behalf of the manufacturer and represents them to the SFDA. One of these tasks is the application for marketing authorizations. Appointment of the AR must be complete before any device application can be made. The appointment is based on an establishment license for the AR and a specific agreement or mandate between the two parties. The SFDA Guidance for Medical Devices Authorized Representatives includes a recommended model agreement.
Marketing Authorization through Authorized Representatives
Once appointed, the AR can apply for marketing authorizations on behalf of the manufacturer via the SFDA web-based system. Each application is for a single device or a family of devices with the same purpose and mode of operation. Fees vary from US$4,000 to US$6,700 (€2,800 to €4,700) per application. The information required for each application is normally supplied by the manufacturer and based on an existing device approval of their choice, either from Europe, the USA, Japan, Canada or Australia. The AR uploads information on behalf of the manufacturer, including: documentation to show a GHTF approval (classification, certification, declarations, registrations, notified body report etc); KSA labeling; a manufacturers declaration; information on transport, storage, environmental and electricity supply requirements; and any KSA advertising material.
Marketing authorization is granted by the SFDA but they involve a small number of appointed Conformity Assessment Bodies (CAB) such as SGS to support them. However, the manufacturer does not have a choice of CAB and there is no direct manufacturer/CAB communication in the marketing authorization process. Once authorization has been obtained, manufacturers are free to ship to, and sell devices in, the KSA.
Deadlines and Actions
The official announcement, 12/10/MDA-AN001, published on 12/29/2010, changed the original implementation dates. The announcement states:
“After 14 August 2011, only medical devices that have a SFDA marketing authorization may be placed on the market within KSA.”
SGS understands this as applying to all imports for the purpose of sale in the KSA and in particular to devices new to the KSA market.
It also states:
“After 31 December 2011, only medical devices that have a SFDA marketing authorization may be put into service within the KSA.”
SGS understands this as applying to the use of medical devices already imported legally into the KSA.
There have been delays with the AR licensing system and of obtaining marketing authorizations, although the system is now operational. Therefore, all the marketing authorizations will not be issued in time to meet either of the deadlines and there may have to be a degree of flexibility in the system. However, to avoid problems at the KSA customs and with the SFDA, overseas manufacturers who currently sell in the KSA must ensure they have an appointed licensed AR, and that applications for marketing authorization are made as soon as possible. Manufacturers entering the KSA market for the first time must ensure the total process is complete before shipping the first batch of devices.
The SFDA has emphasized – in August 2011 – to those CABs working with them the importance of compliance to the new regulations. They have asked CABs, such as SGS, to contact all customers and manufacturers and inform them of the new regulations and the urgency of compliance. To quote the SFDA news bulletin:
“It is therefore important for any manufacturer wishing to place goods on the Saudi market to engage with the process in place at the SFDA without delay. It is likely that failure to either have approval or to be in the process of approval could result in products being prevented from either entering the country or being sold or used”
Saudi Food and Drug Authority – August 24, 2011
The SFDA website is a good source of official information in particular the Regulations and Guidelines and Official Announcements sections. Manufacturers outside KSA should first read Guidance for Overseas Manufacturers, Guidance on Marketing Authorization Procedure and Guidance for Medical Devices Authorized Representatives.
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Medical Device Team
The SGS Group is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With more than 67,000 employees, SGS operates a network of over 1,250 offices and laboratories around the world.