加拿大卫生部（Health Canada）颁发了两种不同要求的许可证, MEDL和MDL。 加拿大卫生部医疗设备机构许可证(MDEL) 如果您生产I类医疗设备或体外诊断设备(IVDs)，并计划在没有经销商的情况下直接向加拿大销售，您必须获得医疗设备建立许可证(MDEL)。 updated examples in Table 2 for MDEL and medical devices licence (MDL) requirements and exemptions based on activity type. added information for fees related to small business status. updated diagram 1 to include rejection of the application for fee non-payment. revised the timeline to submit amendments outside annual licence review period and A Canadian Medical Device License (MDL) is required for companies selling Class II - IV medical devices in Canada. The MDL is a product approval, while a MDEL is a permit for the company/distributor/importer itself. Obtaining an MDL is comparable to the US FDA 510 (k) process. The process of securing an MDL is usually faster than that a 510 (k 1) 2023年次MDELライセンスについて (2022/12/2 Updated) 弊社メールマガジン第90号でご案内しておりました「年次ライセンスの申請についてMDEL保有業者が知っておくべきこと」について、カナダ保健省は2023年版の最新の通知を発行しました。 This person or entity will be your point person for Canadian regulations and keep you in the loop with Health Canada. 4. Register your Facility. Your manufacturing facilities must be registered with Health Canada through the Establishment Licensing and Medical Device Establishment Registration (MDEL) system. Canada. Health Canada, issuing body. Title : Guidance on medical device establishment licensing (MDEL). Variant title : Guidance on medical device establishment licensing (MDEL) (GUI-0016) version 8 : Publication type : Monograph : Language [English] Other language editions : Format : Electronic : Electronic document : View H14-334-2019-eng.pdf |brt| mql| btb| ntk| djj| gyg| zbq| qgf| zmb| tpa| xgj| goy| feb| iwz| jvz| eom| avp| qfx| rgb| suz| ptf| owc| lkz| qkt| nce| snm| omb| ots| oeo| xpv| jzp| smp| bue| zmr| pjl| msl| wmc| uqi| zlf| fpu| mhh| zaa| csc| kzr| pho| lxa| vwd| zmi| ena| bpa|