The Saudi Food and Drug Administration (SFDA) issued updated guidance requirements for medical device listing and marketing authorization. The document is intended to provide medical device manufacturers, their authorized representatives, distributors, and other parties involved with the information on requirements to be met when placing a medical device on Saudi Arabia`s market.
The present SFDA guidance is based on the «Medical Devices Interim Regulation» as the main legislative document regulating operations with medical devices in Saudi Arabia. The aforementioned regulation implements the following rules:
- In order to be allowed for marketing and use, a medical device shall meet the requirements set forth by the Interim Regulation, and its manufacturer shall duly obtain a written marketing authorization to be issued by the Saudi FDA. At the same time, the SFDA is entitled to exempt certain medical devices from the mandatory marketing authorization in case if it is reasonably necessary due to the public health protection needs.
- The manufacturer of the device subject to review should demonstrate compliance of the medical device with the applicable regulations introduced in one of the following countries: Australia, Canada, Japan, the USA, and the EU/EFTA). The medical device in question should also comply with the labeling requirements and pre-conditions for marketing authorization set forth by the «National Provisions and Requirements for Medical Devices» describing national specifics. When issuing the marketing authorization, the SFDA would make its decision based on compliance with the aforementioned requirements.
- Any party involved in operations with medical devices, including both domestic medical device manufacturers and importers making foreign medical devices available in Saudi Arabia, shall duly apply for inclusion of a medical device to the national register of medical devices (the MDNR).
Medical Device Marketing Authorization in Saudi Arabia
The document issued by the SFDA describes in detail the conditions to be met for medical devices to be allowed for marketing and use in Saudi Arabia. All regulatory requirements are divided into several groups depending on their nature.
The general requirement includes, inter alia, the following ones:
- Depending on the type of the device and its class under the risk-based classification, a medical device should be either registered in the course of medical device listing procedure or authorized under the Medical Devices Marketing Authorization (MDMA) to be issued by the SFDA.
- Any medical devices should meet the requirements set forth by the «Essential Principles of Safety and Performance».
- The manufacturer of the device shall have the «Medical Device Technical Documentation» that should be provided to the authority upon request, and also to implement the quality management system (QMS) compliant with the applicable international standard (ISO 13485:2016) or its equivalent.
The submission process itself actually depends on the type of medical device in question and the risk associated with using it.
- Rules for non-sterile, low-risk medical devices without measuring functions:
- The devices of this type are exempted from mandatory authorization, so in order to be allowed for marketing, they should be either registered under the listing procedure or authorized under the MDMA framework as decided by the entity applying for registration.
- The entity intended to place the device on the market shall submit the appropriate application, accompanied by the Establishment National Registry Number and the Medical Device Establishment License (except the cases when the device is being imported by a healthcare institution for its own internal use).
- The application form should be submitted electronically via «SFDA E-Services» and accompanied by the appropriate documents required by the authority.
- A special fee should be paid for these regulatory procedures.
- Other medical devices should be subject to the marketing authorization under the MDMA framework.
- The medical device manufacturer or its authorized representative (in the case of a foreign manufacturer) shall submit the appropriate application.
- The application form should be submitted electronically via the special governmental online service. It is also necessary to submit the documents required under the Implementing Rule (MDS-IR6).
- The appropriate authorization fee should be paid by the applicant.
The SFDA guidance also describes the post-marketing surveillance rules the entity responsible for placing a medical device on Saudi Arabia`s market shall follow, namely:
- the entity shall duly inform the authority on any changes to the application within ten days.
- the application for renewal of the marketing authorization/listing should be filed at least for 60 days prior to the date of the initial authorization/listing expiration.
Additional Saudi FDA`s Requirements for Medical Device Marketing Authorization
When applying for listing of the medical device in the national register or marketing authorization, the applying entity shall submit its application form accompanied by the appropriate documents including, inter alia, the following ones:
- sample of the labeling,
- Instructions for use (eIFU are also allowed),
- Documents demonstrating compliance with the applicable international QMS standard (e.g. ISO 13485:2016),
- Declaration of compliance with the requirements set forth by the Interim Regulation,
- Confirmation of compliance with the requirements implemented in one of the aforementioned countries.
Essential Principles of Safety and Performance for Medical Devices
The document published by the SFDA also describes the safety and performance requirements the device should meet in order to be allowed for marketing and use in Saudi Arabia. In particular, the medical device shall be compliant with the following principles:
- The device shall perform as intended by the manufacturer. The medical device manufacturer shall develop and produce the device in a way ensuring it would perform as intended when used for the intended purpose in accordance with the instructions provided by the manufacturer.
- When being used, the medical device should not expose patients to unnecessary risks. All risks associated with the use of the device should be acceptable – these criteria should be considered on the basis of benefit-risk analysis providing that the risks associated with the use of the device should be compared to the benefits.
- The medical device manufacturer shall take all reasonable measures to reduce the risks associated with the use of the device.
- Any medical device manufacturer is obliged to have a properly implemented risk management system to be applied at all the steps of the device’s lifecycle. Other obligations of the medical device manufacturer in the sphere of risk management include the identification and analysis of potential risks associated with the particular device, risk evaluation, and control, and also the implementation of the appropriate control measures. These measures should comply with the applicable safety principles. First of all, the medical device manufacturer shall justify and evaluate the residual risk (the one that could not be reduced due to the nature of the device) that should be acceptable in terms of benefit-risk balance.
Summarizing the information provided here above, the SFDA guidance on medical device listing and marketing authorization requirements describes the conditions to be assessed by the authority when deciding on the possibility of marketing authorization required by the medical device manufacturer or its authorized representative to be allowed to place the device on Saudi Arabia`s market. In particular, the document describes existing regulatory frameworks to be applied depending on the intended purpose of the device, its type, and class under the risk-based classification. The guidance also provides information regarding general requirements and essential principles to be applied at each step of the medical device`s lifecycle.
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