The article provides an overview of the regulatory requirements for innovative medical devices intended to be marketed and used in Saudi Arabia.
The Saudi Food & Drug Authority (SFDA), the country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to innovative medical devices. It is important to mention that the document constitutes a revised version of the guidance issued earlier by the SFDA and substitutes the previous one. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties interested in placing medical devices on the country’s market. Provisions of the guidance are non-binding in their legal nature, so in case of any discrepancies with provisions of the underlying legislation, the latter should prevail.
First of all, the authority acknowledges the importance of ensuring timely access to medical devices based on novel technologies, as it provides healthcare professionals and customers with additional flexibility in choosing treatment options. For this purpose, the authority has developed and introduced a special regulatory framework intended to reduce the time and regulatory burden associated with placing innovative medical devices on the market while ensuring that any medical devices used are compliant with the respective safety and performance requirements. The present guidance provides additional details regarding such aspects as:
- Determining the eligibility of a medical device for placing on the market under the special framework for innovative products;
- The process of reviewing applications for marketing approval in case of innovative products;
- Specific features of the special framework.
As further explained by the SFDA, the present guidance is based on the “Medical Devices Law” which prescribes the basics of the existing regulatory framework. According to the document, medical devices that employ novel technologies could be subject to exemption from some of the regulatory requirements, provided they are compliant with the general safety and performance requirements. The appropriate approach is set forth under the “Medical Devices Executive Regulation”.
Innovative Medical Devices Pathways
As it was mentioned before, to streamline the review of applications for marketing authorization about medical devices based on novel technologies, the authority has developed and implemented a special regulatory pathway. However, an applicant is still obliged to provide sufficient evidence demonstrating that the product in question complies with the Essential Principles. It is important to mention that the new framework applies to both medical devices being developed and the ones that are currently at the development stage. According to the guidance, the pathway includes two stages:
- Pre-Submission Assessment. The new medical device based on novel technologies should be subject to continuous regulatory assessment within the whole period of its development before the initial application for marketing approval will be submitted.
- Priority Assessment for Marketing Authorization. When applying for marketing approval, an entity responsible for a medical device may request priority assessment designation for its product.
Innovative Medical Device Designation Criteria
The document also describes the specific criteria to be applied when determining the eligibility of a medical device for the special regulatory framework described herein. According to the guidance, a medical device will be considered eligible if it meets the following criteria:
- The medical device is designed with innovative features in the technology, indications for use, or performance attributes that have no equivalence in the local/global market.
- The medical device provides a considerable clinical/medical advantage over existing alternative treatments.
- Any other criteria to be determined by the authority and published through the website.
As further explained by the SFDA, an interested party shall provide sufficient evidence justifying the applicability of the aforementioned criteria. Furthermore, the authority is also entitled to request additional information, should such information be reasonably necessary to assess the case. Once the SFDA will make a final determination, an interested party will be notified accordingly.
Apart from the general points described hereinabove, the document also addresses the aspects related to the SFDA facilitation for innovative medical devices. In this respect, the authority mentions that the information available about the novel technologies is limited due to their specific nature. Hence, the risks associated thereto could be higher as well, so a rigorous assessment is required to ensure the safety of patients. Based on the above, the authority has introduced the following pathways:
- Facilitations for Pre-Submission Assessment Pathway:
- Preliminary Regulatory Feedback – a free service available before the application is submitted, in the course of which the interested party may request feedback and guidance regarding the applicable regulatory requirements, while the authority will also outline the scope of requirements to be fulfilled.
- Facilitations for Priority Assessment for Marketing Authorization Pathway:
- Prioritizing Evaluation. The products based on novel technologies will have the highest priority for premarket review and assessment. However, the authority also mentions that the scope of review would not be reduced as due to the specific nature of innovative medical devices they require a rigorous assessment.
- Granting Conditional Marketing Authorization. In certain cases, innovative medical devices could be placed on the market under conditional marketing authorization which means that special post-market controls and requirements should be applied. In such a case, approval will be granted only provided the applicant complies with any such additional requirements.
- Announcement Release. As soon as the marketing authorization for an innovative medical device has been granted, the authority will make a public announcement.
The authority further describes the specific regulatory requirements to be fulfilled. All the requirements are divided into several groups, namely:
- General. The applicant should ensure compliance with any applicable regulations including, inter alia, Medical Devices Law, and Medical Devices Executive Regulation. The product should meet the applicable eligibility criteria as described herein, and also comply with the Essential Principles for Safety and Performance requirements.
- SFDA Prerequisites. A party interested in placing an innovative medical device on the market should submit the appropriate form accompanied with sufficient evidence demonstrating compliance with the requirements described hereinabove. In particular, the evidence should cover the aspects related to the safety and actual effectiveness of the product subject to review.
- Specific Requirements for Pre-Submission Assessment Pathway. The applicant should also provide additional forms and documentation as required for special pathways described in the guidance.
- Specific Requirements for Priority Assessment for Marketing Authorization Pathway. To claim priority review for its product, an interested party should submit the appropriate application via the electronic system and indicate the respective number of the application for marketing approval. The authority will assess the request and notify the applicant about the decision taken.
In summary, the present SFDA guidance provides a brief overview of the existing regulatory framework for innovative medical devices. The document highlights the most important aspects to be considered including, inter alia, the criteria the product should meet to be eligible for placing on the market under the special pathway for medical devices based on novel technologies.
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