The new article highlights the key points related to the specific categories of changes and describes the way the regulatory status of such changes should be determined based on the nature of such changes, the impact they are expected to have on the safety and performance of the product, and also the risks associated thereto.

The Saudi Food and Drug Authority (SFDA), the country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to changes to medical device marketing approval (MDMA). The document describes the way significant and non-significant changes could be distinguished, provides an overview of the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding changes to the underlying regulations. 

The document describes in detail the requirements to be applied with respect to different types of changes and highlights the key points to be considered.

Changes to the QMS

The scope of the guidance covers, inter alia, the aspects related to changes to the Quality Management System (QMS) to be developed and implemented by the party responsible for a medical device. 

According to the guidance, the changes considered significant include:

  1. Changes to QMS processes. As further explained by SFDA, this includes changes to critical processes that have been already validated, provided the validation is required to mitigate the risks associated thereto. This becomes especially important when the risks could be associated with potential adverse events and harm caused to device users or patients. The examples provided by the authority include the changes to:
    1. Sterilisation method;
    2. The critical parameters of the sterilization process;
    3. A manufacturing process that might impact on pre-sterilization bioburden;
    4. The location for a step in manufacturing; 
    5. A drug coating process;
    6. A viral inactivation process. 
  2. Apart from the above, significant changes to the QMS also include the ones related to the device design.

Changes to Manufacturing Processes, Facilities, or Equipment

The document also outlines the scope of changes considered significant with respect to manufacturing processes, facilities involved, or equipment used. According to the guidance, this includes the changes that have the potential to affect the safety and/or proper performance of the product, for instance:

  • Changes in the equipment used for cutting, resulting in a change in the length of sutures;
  • Changes to molding or cutting manufacturing process;
  • Changes of centrifugation to filtration process which results in better molecule separation;
  • Changes in the implant manufacturing process from casting to 3D printing;
  • Changes from manual operation to automatic operation, without changing the product specification;
  • Changes to the packaging process. 

Apart from the ones listed hereabove, significant changes also include the ones related to the specifications of the product implemented due to changes in suppliers, as well as the ones associated with the quality control processes in the sphere of manufacturing procedures – for instance, removing test acceptance criteria or certain parameters, introducing changes to tests and methods applied to control the product quality, or changing the material acceptance criteria adopted by the manufacturer.  

The document also describes the changes that, according to the applicable regulation, are considered non-significant. According to the guidance, they include:

  • Introducing changes to existing ones or adding new test acceptance criteria in order to improve the reliability or at least ensure the same level;
  • Introducing changes to packaging, providing they are not affecting the sterile barrier integrity (the authority additionally emphasizes that such changes should be subject to validation and stability testing). 

Changes to Software

As explained by the SFDA, specific aspects should be also taken into consideration with respect to changes to the software. It is important to mention that the scope of the guidance covers the changes to both standalone software and software embedded into a medical device. 

According to the guidance, significant change to the software is the one that:

  • Impacts the control of the device that may be altered diagnostic or therapeutic function, such as software change causing the change of critical steps for laser delivery on eye treatment;
  • Initiated by the manufacturer that modifies the algorithm that affects the diagnostic or therapeutic function […] to support physicians in the visualization, identification, evaluation, and reporting of pulmonary lesions/nodules in chest images;
  • Are related to the addition of new features or software applications that affect any diagnostic or therapeutic functions of a device;
  • Includes addition or removal of alarm function;
  • Alter treatment or diagnostic of the patient;
  • Incorporate a change to the operation system platform;
  • Affect the usability of the user interface significantly.

In order to assist the industry in interpreting the above, the authority also provides examples of changes falling within the scope of each of the categories. 

The document also describes the criteria to be applied to determine that the changes in question are non-significant. According to the guidance, such changes include, inter alia:

  • Minor bug fix intended to correct the display error,
  • Disabling functions that are neither affecting the overall performance of the device nor interacting with other functions;
  • Modifying the UI appearance (provided there is no risk associated with impacting the performance of the product).

In summary, the present SFDA guidance describes in detail the requirements to be applied with respect to certain types of changes and their regulatory status. For instance, the authority explains how the significance should be determined when it takes to the changes associated with the QMS, manufacturing sites and processes, and the software used for medical purposes. 

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