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Hello, I looked up the HWC product code which you referred to (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=4656) - this appears to be for a different device than what you are describing.  The HWC code refers to "Screw, Fixation, Bone" as described by 21 CFR 888.3040 ...

Hi Barry, I have had luck in the past using the EU Essential Requirements for Singapore, but I have not submitted a new application in the past year. Singapore also offers expedited routes which leverage Australia, the EU or other markets which may help: https://www.hsa.gov.sg/medical-de ...

Thank you ------------------------------ Elizabeth Goldstein RAC Regulatory Affairs Manager-International Irvine CA United States ------------------------------

Thank you ------------------------------ Elizabeth Goldstein RAC Regulatory Affairs Manager-International Irvine CA United States ------------------------------

Hello, I am seeking some guidance on amendment applications for Health Canada, in particular for class III and class IV medical devices. I have located the following resources - the regulations, guidance document and amendment form: https://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/ ...