The Saudi Food and Drugs Authority (SFDA), a country’s regulating agency responsible for medical devices, has published guidance dedicated to the marketing authorization procedures for medical devices.
The document highlights the most important rules and requirements related to the marketing authorization set forth under the applicable regulations. In particular, the document is based on the provisions of the following regulations:
- Medical Devices Interim Regulation,
- Implementing Rule MDS-IR 5 Licensing of Authorized Representatives,
- Implementing Rule MDS-IR6 Marketing Authorization.
According to the general rule set forth by the Medical Devices Interim Regulation, any and all medical devices allowed to be marketed in the Kingdom of Saudi Arabia should comply with the applicable requirements, and such compliance should be confirmed by the appropriate marketing authorization issued by the regulating authority – the SFDA. The scope of this rule covers all medical devices and accessories thereto, including contact lenses and equipment for cosmetic (non-medical) purposes, while the accessories to medical devices should be treated as separate medical devices. Moreover, all medical devices should comply not only with the local requirements but also with the ones applicable in trusted jurisdictions, such as Australia, Canada, Japan, the USA, and the EU/EFTA. In particular, this relates to the general safety and performance requirements, while the aspects related to labeling and instructions for use are governed by the local requirements.
According to the present SFDA guidance, marketing authorization is not required for in-house medical devices designed and manufactured by the healthcare institutions themselves, providing that such devices are being used solely by the same institutions and are not transferred to any third party.
Applying for Medical Device Marketing Authorization
In accordance with the current regulations, a medical device manufacturer (in the case of an overseas manufacturer – its authorized representative based in Saudi Arabia) shall apply for a medical device marketing authorization (MDMA). Before applying for the MDMA, the applicant shall be also registered with the SFDA and hold the appropriate establishment license.
As it is stated in the present SFDA guidance, an applicant entity applying for the medical device marketing approval shall commit the following steps:
- Submit a Declaration of Conformity with regard to the medical devices subject to review. The Declaration, which should be issued in English, shall confirm the compliance of the medical devices in question with the applicable safety and performance requirements set forth in the trusted jurisdictions outlined hereinabove.
- Submit a labeling sample, which should be issued in English and/or Arabic. The labeling shall contain the information on the intended use of the device, while the way the information is provided should be based on the expected knowledge and qualification of potential users.
- Indicate specific conditions of use associated with the medical devices in question.
- Outline the storing, transportation, installation, and maintenance measures to be followed by the parties using the device.
- Submit an undertaking regarding compliance with the reporting requirements. In particular, the entity responsible for a medical device shall duly inform the regulating authority about any and all adverse events associated with the medical device placed on the market.
According to the regulations, the information outlined hereinabove should be submitted to the regulating authority online via the appropriate electronic application form. In the course of the application procedure, the applicant shall indicate the particular jurisdiction used for reference purposes. The SFDA may ask the applicant to provide additional information in case it is reasonably necessary to assess the application. In general, the documents submitted by the applicant should be sufficient to:
- Identify the medical device that is the subject of the application, its manufacturer, and the legal entity making the application;
- Demonstrate the device complies with all relevant provisions specific to the KSA;
- Demonstrate the manufacturer of the device has been authorized to place the device in the market in one of the five GHTF Founding Member jurisdictions.
Should the information submitted by the applicant be found sufficient, the SFDA would notify the applicant that the marketing permission has been granted and assign the appropriate Medical Device Listing National Registry Number, which would be used for all further references related to the medical device in question. This number would be later used for tracking purposes and marketing control procedures. Upon successful completion of the application process and placing a medical device on the market, the applicant would become an entity responsible for a medical device, hence, be bound by the respective requirements on post-market surveillance.
In case if the scope of application covers more than one type of medical device, the applicant shall submit information about each type separately.
Information to be Provided to SFDA
The present SFDA guidance also describes in detail the information to be submitted with regard to the medical device itself, its manufacture, and also the applicant entity.
According to the guidance, the general information to be submitted by the applicant shall include:
- Contact details of the medical device manufacturer,
- National Registry number (for local manufacturers),
- Contact details and National Registry number of an authorized representative (for an overseas manufacturer),
- Name and contact details of the particular persons responsible for completing the application form,
- Details about the medical device in question,
- Indication related compliance of the medical device subject to review with the applicable requirements set forth by one or more of the GHTF Founding Member jurisdictions.
It is important to mention that local medical device manufacturers may also refer to the appropriate guidance issued previously by the SFDA.
The guidance also clarifies the local requirements related to medical devices. As it was mentioned before, the local requirements cover such aspects as advertising and labeling.
For instance, according to the aforementioned requirements:
- It is strictly prohibited to advertise medical devices that are not duly authorized for marketing in Saudi Arabia,
- All promotional materials related to medical devices should be subject to prior approval,
- The information and statements contained in the marketing materials should be accurate and not misleading,
- The persons involved in marketing should have sufficient knowledge,
- The advertising materials aimed at healthcare professionals should contain information compatible with their specific needs.
The SFDA additionally emphasizes that in the case of medical devices intended to be used by laypersons (non-professionals), all information should be provided in a clear and understandable format in order to ensure that users having no special qualification or knowledge would be able to understand the information and use the device in a safe and correct way.
In the course of the application process, the applicant shall provide electronic copies of the labeling, together with the instructions for use. The regulating authority would review the samples provided and determine whether they are compliant with the applicable requirements.
Summarizing the information provided here above, the present SFDA guidance outlines the main aspects related to marketing authorization of medical devices in accordance with the current legislation of the Kingdom of Saudi Arabia. In particular, the document describes the obligations of the entity interested in placing a medical device on Saudi Arabia`s market and provides additional clarifications regarding the particular actions to be performed, together with the references to the applicable regulations.
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