Hi Covers - I am using the Health Canada (HC) Guidance regarding interpretation of Significant Changes. I have a couple of questions about Flowchart F (materials change in non-IVDD device):
1)It states that if the supplier of the material changes but it meets the manufacturer's "previously reviewed acceptance criteria" then the change is not significant. What is meant by "previously reviewed acceptance criteria"? Is this the finished product specifications or the acceptance criteria for the raw material itself? I understand that "previously reviewed" means reviewed and approved by HC.
2) How do I interpret the phrase "If the device is a surgically invasive device intended to be absorbed by the body or to remain in the body for for at least 30 consecutive days..."? Does this mean the device must be a) surgically invasive and absorbed OR b) surgically invasive and remain in the body for at least 30 days? My device is not surgically invasive but will remain in the body for at least 30 days in contact with body tissues/fluids so just wanted to make sure I am reading this correctly.
Thanks for your help!
1)It states that if the supplier of the material changes but it meets the manufacturer's "previously reviewed acceptance criteria" then the change is not significant. What is meant by "previously reviewed acceptance criteria"? Is this the finished product specifications or the acceptance criteria for the raw material itself? I understand that "previously reviewed" means reviewed and approved by HC.
2) How do I interpret the phrase "If the device is a surgically invasive device intended to be absorbed by the body or to remain in the body for for at least 30 consecutive days..."? Does this mean the device must be a) surgically invasive and absorbed OR b) surgically invasive and remain in the body for at least 30 days? My device is not surgically invasive but will remain in the body for at least 30 days in contact with body tissues/fluids so just wanted to make sure I am reading this correctly.
Thanks for your help!