What Tests Are Needed For Orthopedic And Oral Implant Devices To Add Sterilization Methods In A Registration Of Change?

If a manufacturer intends to add more sterilization methods in a change of permission items, the corresponding sterilization verification data and test the sterility performance should be submitted. Any other performance changes caused by the addition of sterilization methods should be tested. For example, if ethylene oxide sterilization method is newly added, sterility test and ethylene oxide residue test must be added.