Late last month, the CFDA released a draft document updating their Classification Catalogue for medical devices. The currently used classification catalogue for medical device was published in 2002 and in the time since its issue, the CFDA has identified some deficiencies in its provisions, specifically that:
- It only provides device categories, device types and typical device names, without specific functional descriptions or intend uses for such devices. Therefore, in a practical sense it can be difficult to classify a prospective device.
- The overall design of the catalogue and designation of devices into a hierarchy is poor and may cause confusion; for example, there are some overlapping product types or sub-types.
- Technology has advanced and the devices covered by the current catalogue does not adequately reflect the breadth of new devices that have been developed since. Although CFDA has published supplementary classification announcements for those new devices, there hasn’t been a consolidated catalogue in which all devices are contained.
The proposed revision of the classification catalogue has re-defined device categories, this time classifying device types and sub-types according to functionality and clinical application. In this way, all new devices that do not appear in the current classification catalogue can be integrated with the existing device types in one single registry.
It has 22 device categories as listed below Table 1. There are multiple device types under each category, and multiple sub-types under each device type. The detailed device description, intended use, a number of typical device names and classifications (I, II, III) are assigned to each sub-type. The hierarchy is shown in below Figure 1.
In total, under the 22 device categories, there are 205 device types, 1,136 sub-types and 5,641 typical device names in the catalogue. The presentation of the catalogue has been maintained from the original catalogue, with one example of a catalogue entry shown below in Table 2.
Please note that IVD devices are not included in this proposed revision of classification catalogue. CFDA is maintaining a distinct classification catalogue for IVDs.
The CFDA is seeking industry feedback on the updated catalogue and they will be accepting written feedback to the Medical Device Registration Division of the CFDA as well as feedback via emails to firstname.lastname@example.org
Table 1: Categories
|#||Category Description ( %)|
|1.||Active Surgical device|
|2.||Non-active surgical device|
|3.||Neurological and cardio-vascular surgical device|
|4.||Orthopedic surgical device|
|5.||Radiological therapy device|
|6.||Medical imaging device|
|7.||Medical diagnostic and monitoring device|
|8.||Respiratory, anesthesia and emergency therapy device|
|9.||Physical therapy device|
|10.||Blood transfusion, dialysis and extra-corporeal circulation|
|11.||Sterilization and disinfection equipment for medical device|
|12.||Active implantable device|
|13.||Non-active implantable device|
|14.||Infusion, nursing and protection device|
|15.||Patient bearing equipment|
|18.||Gynaecology & obstetrics, reproduction assistance, contraception device|
|19.||Medical rehabilitation device|
|20.||Traditional Chinese medical device|
|22.||Clinical examination device|
Table 2: Example of a device classification
|Category:||01 – Active surgical equipment|
|Device type:||High frequency/ radio frequency surgical equipment|
|Sub-type:||01 – High frequency surgical equipment|
|Device description:||Usually is composed of high frequency generator, surgical hand piece, surgical electrode (including neutral electrode), connection cable and foot paddle. The high frequency current is generated between the two electrod (usually higher than 200kHz)|
|Intended use:||To be used to cut and coagulate the tissue in regular surgical procedure|
|Typical device names:||High frequency electrotometer, high frequency surgical equipment, bipolar electrical coagulator, high frequency surgical system, high frequency electrical surgical system, plasma radiofrequency treatment system, radiofrequency ablation|
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