Saudi Food & Drug Authority (SFDA) is the regulatory authority for medical devices sold and distributed in Saudi Arabia. Prior to marketing your medical devices, you need to register your product with SFDA. Compliance with SFDA regulatory guidelines for medical devices is mandatory for securing the SFDA medical device registration. Recently, the regulatory authority has released a SFDA significant and non-significant changes guidance document. In this blog, we have discussed the type of changes to medical devices that will be considered significant or non-significant. Additionally, we have mentioned the reporting requirements for the different categories of changes.
What does the guidance document on SFDA significant and non-significant changes contain?
Recently, SFDA has released a guidance document explaining significant and non-significant changes of registered medical devices. The guidance document mentions any change made by the medical device manufacturer should be categorized as significant or non-significant. Accordingly, these changes have to be reported and notified to the SFDA. Additionally, the SFDA significant and non-significant changes document mentions the obligations of manufacturers with respect to changes depending on their significance. Furthermore, the document sheds light on type of changes made to medical devices. The document has defined significant and non-significant changes related to the manufacturing processes, intended use and labelling, design, safety and performance, QMS, and software. We have highlighted the obligations of manufacturers mentioned in the document:
- Significant changes: A significant change will require SFDA approval. A report on the significant changes has to be sent to the SFDA within 10 days of the change.
- Non-significant changes: A non-significant change does not require SFDA approval. SFDA needs to be notified of the non-significant change within 30 days of the occurrence of the change.
SFDA significant and non-significant changes
We have highlighted some of the SFDA significant and non-significant changes with respect to certain parameters.
Changes to manufacturing processes, facilities or equipment
Significant changes
Changes in manufacturing processes, facilities, or equipment (including changes to outsourced processes) that may affect the safety or performance of the device will be considered significant. Also, changes to manufacturing quality control process or procedures are placed under the significant changes bracket. The changes considered significant are:
- Change from manual operation to automatic operation, without changing the product specification.
- Changes in the equipment used for cutting resulting in a change in the length of sutures.
- Changes to the molding or cutting manufacturing process.
- Change of centrifugation to a filtration process which results in better molecule separation.
- Changes to the packaging process.
- Changes in the implant manufacturing process from casting to 3D printing.
- Removal of test acceptance criteria, in-process inspections, or final inspections without replacement of these activities.
- Changes to the manufacturer’s requirements for material acceptance criteria, if it alters the design specifications of the device.
- Changing the methods, tests or procedures used to control the quality, purity and sterility of the materials or the device.
Non-significant changes
We have also highlighted some examples of non-significant changes:
- Adding new or modifying existing test acceptance criteria or test methods to achieve equivalent or better reliability assurance.
- Changes in packaging that do not affect the sterile barrier integrity of a device, or its performance after storage, shelf life, or changing to the storage requirements. However, validation and stability testing must demonstrate that the integrity of the system is not compromised.
Changes to intended use and labelling
Significant changes
- Changes to the name or model of the device
- Changes to name and/or address of the manufacturer
- Changes to information on the label or IFU considered an important part of the risk mitigation measures for using the device, for example to add a contraindication, warning, or other important information about safe use of the device.
- Changes to the intended purpose, such as broadening the clinical indications, therapeutic use, patient groups or users.
- Changes to sterilization status/method
- Changes to the labelling from single use to re-usable
- Adding a new procedure for a use or purpose
- Changes to the MRI compatibility status of a device
- Changes to the storage conditions for a device whose performance may be impacted by these conditions
Non-significant changes
- Changes to the artwork, color, font, or layout of the packaging and labelling of a device.
Changes to Design
Significant changes
- Changes in the intended use/intended users
- Changes affecting the product’s risk management file
- Changes of the materials
- Changes in operating principle
- Changes in design specifications
- Changes in the device packaging or storage
- Changes in the sterilization
- Changes in the control mechanism
- Changes in technology, engineering, performance, or materials of an IVD
- Changes in components or accessories
- Changes in the device’s energy input and/or output
- Changes in the human factors of the patient or user interface
- Changes in the operation environment
- Changes that require new clinical data
Non-significant change
- Changes that will not impact the design or the intended purpose of the device
Changes to safety and performance characteristics
Significant changes
- Clinical and analytical data that is obtained through new studies could prompt a significant change to the safety and/or performance of the device. For example, changes to diagnostic sensitivity or the inclusion of new interfering substances in the instructions for use.
Changes to software
SFDA significant and non-significant changes guidance document focuses on changes to both standalone software and software embedded in a medical device.
Significant changes
- Changes to software that alter treatment or diagnostic of the patient
- Changes that impact the control of the device
- Changes that are initiated by the manufacturer that modifies the algorithm
- Changes in software that includes a change in the operating system platform
- Change to software that significantly affect the usability of the user interface
- Changes related to the addition of new features or software applications that may affect diagnostic or therapeutic functions of the device
- Changes to software that includes addition or removal of alarm function
Non-significant changes
- Changes in software to disable certain functions that do not interact with any functions or affect the performance of the device
- A simple bug fix to correct the display error
- Changes in software to modify the appearance of the user interface with minimal or no impact on performance.
Changes to quality management system (QMS)
Significant changes to QMS are changes in critical validated processes, particularly changes to a process where the validation is crucial to reduce risks related to that process. Patients or users may suffer adverse effects, if the risks are not addressed.
Significant changes
- Changes in critical parameters of the sterilization process
- Changes to the sterilization method
- Change in a viral inactivation process
- Change in a drug coating process
Changes to sterilization
Significant changes
- Changes to the sterilization process or equipment or cycle parameters
- Changes that increase the bioburden alert, action levels, or that introduces a more difficult to kill organism
- Changes to the quality control verification and validation process
- Changes in the density or configuration of the sterilization load
- Changes in device design or material that introduces a more difficult to sterilize feature
Non-significant changes
- Adding a new test acceptance criteria or test method, over and above the existing process
- A change from a pre-blended sterilant (EO and CHCs) to EO post-blended with nitrogen
- A change from using Air (mixture of 80% Nitrogen and 20% Oxygen) to pure Nitrogen in the aeration process to avoid explosive gas mixtures
- Changes in air-flow or HVAC system in the manufacturing environment
In this blog, we have summarised the key takeaways of the SFDA significant and non-significant changes guidance document. For any queries or SFDA regulatory support, drop an email at [email protected] or call/Whatsapp on 9996859227.
