Medical Device Related Regulations

Medical device regulations around the world. Regulations are laws set by a regulatory authority of a country or region and are generally mandatory.

Canada Medical Device Regulations

This forum is for Health Canada regulations and other applicable regulations related to medical devices in Canada.
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Canadian Med Device distributors per MDSAP need to be treated as suppliers...

China Medical Device Regulations

SFDA regulations and other applicable regulations related to medical devices in China.
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128
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656
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128
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656
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Returning Overseas Implantable Complaint Product to China

EU Medical Device Regulations

The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
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Post-market surveillance

Japan Medical Device Regulations

MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
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102
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436
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102
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Does my "new" assay require a clinical study? or will a reference interval study suffice?

UK Medical Device Regulations

UK Medical Device Regulations, especially with respect to BREXIT issues.
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80
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338
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80
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Qualification of Medical Transcription Software

US Medical Device Regulations

United States Medical Device Regulations
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Sub-forums:
  1. 21 CFR Part 820 - US FDA Quality System Regulations (QSR)
  2. Other US Medical Device Regulations
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California Prop 65 requirements as they relate to 820.120

Other Medical Device Regulations World-Wide

Regulatory systems around the world different from the ones in the above sub-forums.
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Korea MFDS Regulation on Advertising - only to Healthcare professional
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Ear, nose, and throat E.N.T devices
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nizark
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MAUDE Report
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margadia
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Transport of components off site for final assembly.
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regi_601
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Add MDSAP to Internal Audit Schedule
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AADIVISH
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Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device
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jdlin47
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