(i) Intended purpose
(ii) Passive medical devices
(iii) Active medical devices
(iv) Invasive devices
(v) Reusable surgical devices
(vi) Implantable devices
(vii) Devices that come into contact with the body
(viii) Time limit for use
(ix) skin
(x) cavity (mouth)
(xi) trauma
(xii) tissue
(xiii) blood circulatory system
(xiv) the central nervous system
(xv) stand-alone software
(p) (xvi) medical devices with measurement and testing functions
(xvii) chronic trauma
Medical devices in accordance with the degree of risk from low to high, the management category is divided into Class I, Class II and Class III.
One class can directly apply for a business license
The second class needs to do the record to the Drug Administration
The third class needs to be given by the Food and Drug Administration of the medical device business license