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Canada announces modifications to the transition to the Medical Device Single Audit Program (MDSAP)

Changes to the transition process are intended to make it easier for manufacturers to switch to MDSAP. The MDSAP was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of quality management systems (QMS). Health Canada’s decision to replace the Canadian Medical Devices Conformity Assessment System (CMDCAS) and require an MDSAP audit to maintain Canadian Device Licenses is leading to a rapid increase in use of the programme. Health Canada expected manufacturers to submit a valid MDSAP certificate to the Medical Devices Bureau by December 31st, 2018.

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Will you need more space on your labels?

One area that has been changed substantially in the Medical Devices Regulations (MDR) and In Vitro Diagnostic Medical Devices Regulations (IVDR) relates to the information to be provided with medical devices and in vitro diagnostic medical devices (IVDs). Annex I in each Regulation details the general safety and performance requirements. Chapter III of this Annex gives the requirements for information to be supplied with the device. This includes information on the label as well as in the instructions for use (IFU). All labels and IFUs will need to be reviewed and updated. One practical implication of the amount of additional information stipulated to be included in the label is that the labels will likely need to be bigger.

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