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Does US class 1 require - "complaint handling unit, to raise and analyze every adverse effect on the field, and report to regulatory bodies the worst hazardous
by danvoell 7y ago
Does US class 1 require - "complaint handling unit, to raise and analyze every adverse effect on the field, and report to regulatory bodies the worst hazardous case in a limited time frame, be able to do recall and so on." - Don't know so I'm asking. I would assume any product with class 2 has these requirements. My assumption under class 1 is that you need to be able to determine you built the product to a predefined set of specifications.
- seehafer 7y agoYes. Complaints are part of the Quality System Regulation that all device manufacturers selling in the US must abide by.
- seren 7y agoThe device is registered in Canada and I found that information [0] : >For all devices except Class I, implement an ISO 13485:2016 under the Medical Device Single Audit Program (MDSAP) compliant quality management system, which includes the specific requirements of the CMDR. ISO 13485 certification, used to demonstrate compliance with European regulations, does not meet Canadian requirements. Updates to the existing procedures, or new procedures, must be implemented. So it seems you don't need to implement post market surveillance for a class 1 device or having a complaint handling unit. [0] https://www.emergobyul.com/resources/canada-process-chart https://www.emergobyul.com/resources/canada-process-chart