We are a small company wishing to distribute an annex 2 list B IVD, manufactured by an ISO 13485 certified company in China. We are working towards ISO13485 certification. I'm looking for some help with what should be included in the supply contract from our point of view regarding things like PMS, vigilance, traceability, managing changes etc. Is specifying these requirements necessary or is it assumed within their CE approval and ISO13485 certification that they would notify us of any quality issues automatically? Presumably they will expect the contract to contain the requirement to notify them if we became aware of any problems with the product? Any help with what should be included and drafting the wording of a contract would be very gratefully received. Thank you.