1, the domestic class I medical devices, from June 1, 2014, according to the notice issued by the drug monitoring system (CFDA Circular 2014008 on the release of the product catalog of Class I Medical Devices (No. 8)), or the classification definition results from June 1 as a class I, can be as a class I medical device;
2. Drug-containing devices with the function of medical devices are mainly declared in accordance with Class III (e.g. condoms containing drugs are Class III medical devices), and if the function of drugs is mainly declared, it should be declared in accordance with drugs (e.g. band-aid containing drugs is a drug)
The main process of registration is to write the standard - testing for product registration - clinical trials - system assessment - and Finally, the registration audit.
The main decision time is testing and clinical trials. The more complex the test items, the longer the time will be, and the same is true for clinical trials, such as Class III implantable medical devices than non-implantable devices to spend much more time.
The overall time can range from 1 year to 5.6 years.