Saudi Food and Drug Administration (SFDA) has issued two guidance dedicated to innovative medical devices and new applicable standards. Both guidance have been developed during the process of making general improvements to the medical device regulatory framework as announced by the authority.
SFDA Innovative Medical Device Regulation
The first guidance issued by the SFDA is dedicated to innovative medical devices. It is intended to eliminate the delays in patients gaining access to the newest medical devices and technologies. The authority aims to find the balance between reducing the time needed for the innovative device to be placed on the market and maintaining high safety standards that prevent harm caused by medical devices. The document covers the most important aspects related to the application review process.
The guidance is based on the principles established by the Medical Device Interim Regulation, the main act in the sphere of medical device circulation. According to these principles, medical devices can only be placed on the market if they comply with all applicable safety and effectiveness requirements. These requirements should be confirmed in writing by marketing authorization issued by the regulating authority. At the same time, the SFDA reserves the right to exempt medical devices from the obligatory authorization process by publishing the appropriate notice. As usual, the authority takes additional measures to simplify access to the market in case the delays could cause harm to patients, restrict access to innovative technologies, or reduce the number of treatment options available.
First of all, the authority defines the devices that fall within the scope of the guidance by providing a list of criteria an innovative medical device should meet, namely:
- It should be based on the novel technologies that have not been present on the market before or there is no equivalent device;
- It provides benefits for patients, e.g. clinical advantage over any existing technology or there is no alternative treatment approach available.
Thus, the manufacturer applying for the innovative medical device registration has to prove that it meets the aforementioned criteria to be eligible to use the special pathway while the authority is entitled to request the manufacturer to provide any additional information reasonably necessary to identify the device as an innovative one.
The regulatory approach to innovative medical devices, in general, is based on the idea that such devices are always associated with a higher risk due to their nature. That is why they require more attention and should be subject to scrupulous assessment. As usual, unexpected delays in the review process can take place due to a lack of information provided by the manufacturer – in some cases it is not sufficient for the authority to perform safety and performance assessments. Thus, it is quite important for the manufacturer to properly prepare all the documents that could be necessary to confirm the compliance with applicable requirements.
To improve communications with applicants, the authority has introduced the following procedures:
- Prioritizing evaluation. The SFDA will focus on the applications related to innovative medical devices first since they require more attention. At the same time, the authority is not going to reduce the scope of assessment to reduce the time needed to perform it.
- Assigning Case Manager to communicate directly with the applicant during the whole application review process. This approach could substantially improve the effectiveness of communications between an applicant and the authority.
- Granting Conditional Approval providing that the applicant is allowed to make its device available on the market under certain limiting conditions while the full scope approval would be granted only upon the confirmation of compliance with all applicable requirements.
The authority also requires an applicant to provide sufficient evidence of the safety and effectiveness of an innovative medical device, e.g. clinical study data. At the same time, an applicant would have to provide all the documents usually required for the particular safety class the device is assigned to. To be allowed to use a special pathway, the manufacturer must apply for the appropriate designation. In particular, it would be necessary to provide Innovative Medical Device Declaration Form and Innovative Medical Device Summary.
SFDA Guidance on Recognized Standards
The second guidance published by the SFDA covers aspects related to the standards medical device manufacturers are allowed to refer to in confirming the compliance with safety and performance requirements. The list containing all standards recognized by the authority for reference purposes is available on the SFDA’s official website, and the authority keeps the list up to date. At the same, the standards themselves are not in free access and need to be purchased separately. The list of recognized standards includes ISO and IEC standards approved to be used within the application process.
According to the Medical Device Interim Regulation, the SFDA is entitled to develop and approve both mandatory and non-mandatory standards in the sphere of medical device circulation.
In particular, the standards recognized by the SFDA could be divided into the following groups:
- Standards related to injection, infusion, transfusion and blood processing equipment (including plastic containers for human blood or intravenous injections),
- Respiratory and anesthetic equipment (e.g. medical gas pipeline systems and anesthetic and respiratory equipment),
- Implants for surgery (including both active implantable medical devices and non-active implants),
- Orthotics and prosthetics,
- Surgical instruments, (covering a wide range of surgical instruments, such as scalpels, and also certain categories of medical equipment),
- Optics and photonics (e.g. ophthalmic implants and ophthalmic optics),
- Assistive products (e.g. technical aids for disabled persons),
And other groups together covering a wide range of devices of different types.
Other Regulatory Changes in Saudi Arabia
The authority also announced that medical device manufacturers would be allowed to make references to the registration process existing prior to the implementation of the new rules for four additional months. Due to the extension of the transition period, they would be able to register or renew the registration under the new framework. This possibility was introduced by the SFDA to assist medical device manufacturers failing to comply with new requirements in the time since a lot of them have not managed to finalize the registration process within the initial term.
The SFDA also extended the period during which the Medical Device Marketing Authorization (MDMA) applications could be submitted through the electronic system existing prior to the implementation of the new GHAD platform which actually constitutes a unified platform combining the features of separate systems. The initial implementation date was December 26, 2019, but the authority decided to extend the transition period allowing to access the applications uploaded to the old system that were not submitted yet.
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Innovative Medical Device Guidance (download link: https://www.sfda.gov.sa/ar/medicaldevices/regulations/DocLib/MDS-G43.pdf)
Guidance on recognized standards (download link: https://www.sfda.gov.sa/ar/medicaldevices/regulations/DocLib/MDS%E2%80%93G44.pdf)