![]() ![]() changes to the quality control validation process such as introducing parametric release. ![]() changes in the density or configuration of the sterilization load.changes in sterilization process or equipment or cycle parameters.a change to the manufacturing environment outside of the sterilization facility may not be a significant change.changes to the manufacturing environment (note that if the sterilization process and facility is physically and/or environmentally segregated and managed from other areas.manufacturing changes that affect the original bioburden of the device.This flowchart describes the required documentation pertaining to changes in sterilization method or process for medical devices or to any changes that might affect the effectiveness of the process. Long Description - Appendix 5: Flowchart D - Changes to Sterilization Do the results of a risk analysis, undertaken during the design validation process, raise new issues of safety and effectiveness, or are any risks changed and/or increased for any issues of safety and effectiveness?įlowchart D - Sterilization of Medical Devices.Are clinical data necessary to support the safety and effectiveness of the altered device?.Does the change affect the indications for use?.If the response to any of the following three questions is yes, then it is likely that the design change is significant and a licence amendment application would be required. The results of this validation process for each proposed change are then used to determine if a licence amendment application is required.Ĭhanges to the design specifications, physical description, patient or user interface, software or firmware may be significant if they affect the indications for use of the device. All design changes must be evaluated and validated according to the accepted procedures recorded in the quality management system. Long Description - Appendix 4: Flowchart C - Changes in DesignĬhanges in design span the full spectrum from minor engineering changes to major changes in operating principles. When a supplier's manufacturing process, facility or equipment changes, this is not a significant change provided device specifications have not been changed and incoming inspections to evaluate the material/equipment provided by the supplier have not been changed. The manufacturer is also required to submit a licence amendment. In cases where the manufacturer's name and address on the device labelling stays the same but a new manufacturing facility is added, the new facility will need to be covered by the manufacturer's quality management system certificate. For example, this may include changes to the packaging process, which is a component of manufacturing.įor changes to the manufacturing facility that lead to a change of the manufacturer's address on the device labelling, the manufacturer will be required to submit a new licence application. Long Description - Appendix 2: Flowchart A - Changes to Manufacturing Processes, Facility or EquipmentĪ change to the manufacturing process, facility or equipment that impacts the safety or effectiveness of a device is significant, and therefore an amendment is required. These examples are grouped according to the type of change.įlowchart A - Changes to Manufacturing Processes, Facilities or Equipment The third tool (Appendix 10) is a list of examples of significant and non-significant changes.If the change is significant, then a licence amendment application must be submitted to Health Canada. The accompanying discussions and flowcharts are intended to define the processes used to answer the question, "is this a significant change?". The "Main Flowchart" provides assistance in identifying which of these charts will be helpful. The nine flowcharts described in sections 2.3 to 2.11 (also presented in Appendices 1 - 9) are a second tool which details specific questions and answers to assist manufacturers in determining if a change is considered to be significant.įlowcharts A to H detail the most common types of changes made to medical devices.The first tool is a generalized discussion of the broad principles that can be used to determine if a change would affect the safety and effectiveness of a medical device (section 2.2, "Significant Changes: General Principles"). ![]()
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