CFDA did some reasonable adjustment for the product management category. Based on the new regulation, some products are not managed as medical devices as before.
The expanded list of non-medical devices
- Radiotherapy patient mattress for the patients supporting during the radiotherapy has to register with the radiotherapy medical device. It cannot register as an individual medical device.
- Medical gamma-ray sterilizer is not used in the medical environment. And there is not any products registered in CFDA so it will not be included in the medical device catalog.
- Syringe piston was classified as class III medical device in the past, but in the new regulation it is not managed as a medical device.
- Infusion bottle stickers---It is used for sealing the opening venous infusion bottle outlet to prevent contaminate infusion liquid. This product is not conformed to the medical device definition so in the new catalog it will not be the medical device.
- Infusion Workstation was the class II medical device in the past. It provide space and power supply but not with warning function. As a result, it is not consistent with the medical device definition so it is not belongs to the medical device catalog.
- Trial frame used to be class I medical device but now it is managed as the non-medical device.
- Vaginal filling products containing disinfectant (antimicrobial) was class II medical device previously, however, in the new catalog it belongs to non-medical device.
- If the remote medical consultation system software not includes medical images or data, it will be non-medical device.
- The 6870-5 human anatomy measurement software in the classification catalog (Year 2002 edition) did not have any CFDA registered products previously. And it not follow the definition of medical device so it will no longer be medical device.
- The product that related to the clinical trials itself does not have any medical device function. This kind of product will not be included in the medical device catalog. Ex: transfer pipette, general reaction glass, reaction tube and plate and etc.
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