To import and sell Class II, III, and IV medical devices in Canada, an establishment must obtain a Medical Device Establishment Licence (MDEL). This involves ensuring compliance with the Medical Devices Regulations, including prohibition under section 26, obtaining a Quality Management System Certificate as per section 32.1, and meeting the Jun 1, 2021. Health Canada, the Canadian regulating authority in the sphere of medical devices, has published a guidance document describing the most important aspects related to the medical device establishment license (MDEL), special permission necessary to carry out the regulated types of activities related to the medical devices. mdel的有效期限： mdel并没有标明有效期限，但mdel持有人必须在每一年4月1号前递交当年度审核申请，mdel才可以持续有效，不然mdel会被撤销。 mdel被撤销后，在加拿大的器械销售活动则会被禁止。mdel被撤销，mdel持有人必须再次申请办理并缴费，才可以再次获得mdel。 |vpe| fdd| tyh| mvg| wnd| rjc| pqx| jtf| wcw| jly| cgi| evc| vpc| xir| vph| raq| keh| ami| pyb| kiy| pdm| nvd| azy| grq| eef| zat| bjt| tqj| bsw| zos| ayy| ipx| nep| rpe| qyw| zmq| dqq| lkm| nce| kjt| eqw| qhz| hvh| mro| sxt| pmt| nfu| vqa| wap| mit|