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Commercialization of Medical Technologies - Coggle Diagram
Commercialization of Medical Technologies
Medical Device
Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material, or other similar or related article intended by the manufacturer to be used, alone or in combination for human beings.
Risk classification
factors influencing classification
intended action on the human body
devices comes into contact with injured skin
Device is intended to have a biological effect on the body
diagnosis or treatment
Device deliver medicines or energy to the patient
ability to be reused or not
Degree of and site of invasiveness into the body
combination of devices
Duration of contact with the body
Non-invasive medical device
invasive medical device
additional rule
active medical device
Grouping of MD
General medical device
single
system
SET
family
invitro medical device
Single
family
system
set
IVD test kit
IVD kluster
Common Submission Dossier Template (CSDT)
element of CDST
Summary of design verification and validate documents
Device labelling
Device description
Risk analysis
Essential principle of safety and performance
Manufacturing information
Executive summary
Conformity assessment
to recognize the conformity assessment and approval of medical devices in the market of selected countries
undergoes a simpler process of verification of evidence-based compliance obtained from the manufacturer of the MDs
Conformity assessment Body (CAB)
body registered under the Act to carry out conformity assessment of a medical device to be registered under the Act