Starting from January 2017, the “Priority Review and Approval Procedure for Medical Devices” entered finally into force. The reform is an innovative system of laws and in-progress regulations.
This reform wants to satisfy the request of Medical Devices from healthcare professionals and users in the territory through Medical Devices specific rules.
For example, recently the “Medical Device Classification Catalogue” has been set up to associate a specific category to each medical device and allow the application of the right CFDA registration procedure (read the article).
To date CFDA has released four main guidelines for some medical device categories as, for example, magnetic resonance imaging (MRI) systems, defibrillators and computed tomography systems.
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