CFDA is planning to down-size the number of categories for medical devices

14 Jun

CFDA is planning to down-size the number of categories for medical devices

The China Food and Drug Administration (CFDA) has been using the four-digits category system for medical device since the year of 2000. Currently, all medical devices are divided into 43 categories from “6801” to “68xx”. The category information is embedded in the CFDA certification number as the second and third digits. For example, a certificate of 2016-3642017 shows the product is in the category of 6864 Medical sanitation material and dressing.

IndexCategoryDescription
16801General surgery instrument
26802Microsurgery instrument
36803Neurosurgery instrument
46804Ophthalmic surgery instrument
56805ENT surgery instrument
66806Stomatological surgery instrument
76807Thoracic and vascular surgery instrument
86808Abodomal surgery instrument
96809Urology and anorectal surgery instrument
106810Orthopedic sugery instrument
116812Gynaecology and obstetrics surgery instrument
126813Family planning surgery instrument
136815Injection and puncture device
146816Burn (plastic surgery) surgery instrument
156820General diagnostic device
166821Medical electrical equipment
176822Medical Optical apparatus and instrument & endoscopic equipment
186823Medical ultrasound device and relevant equipment
196824Medical laser equipment
206825Medical high-frequency equipment
216826Physical treatment and rehabilitation equipment
226827Chinese medicine device
236828Medical magnetic resonance equipment
246830Medical x-ray equipment
256831Medical x-ray ancillary equipment and component
266832Medical high-energy ray equipment
276833Medical nuclear equipment
286834Medical ray protection articles and apparatus
296840Clinical diagnostic analysis device
306841Clinical assay and basic equipment and instrument
316845Extracorporeal circulation and blood processing equipment
326846Implant material and artifical organ
336854Operating room, ER and examination rooom equipment and instrument
346855Stomatology equipment and instrument
356856Ward care equipment and instrument
366857Disinfection and sterilization equipment and instrument
376858Medical cold therapy, low-temperature, refrigerating equipment and instrument
386863Stomatology material
396864Medical sanitation material and dressing
406865Medical suture material and adhesives
416866Medical polymer material and product
426870Software
436877Intervention instrument and material

Now the CFDA plans to simply the category system. A draft proposal is made on September 30th, 2016, in which the number of categories is reduced to 22 (from “01” to “22”).  Although changes may still be made to this draft version, it is said that the new system will be adapted by the end of 2017.

CategoryDescription
1Active surgery instrument
2Non-active surgery instrument
3Neurological and Cardiovascular surgery instrument
4Orthopedics surgery instrument
5Radiation therapy device
6Medical imaging device
7Medical diagnositic and monitoring device
8Respiration, anesthesia and ER device
9Physical treatment device
10Blood transfusion, dialysis and extracorporeal circulation device
11Disinfection and sterilization device for medical devices
12Active implant device
13Non-active implant device
14Infusion, nursing and protecting device
15Patient carrying equipment
16Ophthalmic device
17Stomatological device
18Obstetrics and gynecology, assisted reproductive and contraceptive devices
19Medical rehabilitation device
20Chinese medicine device
21Medical software
22Clinical assay device

The more simplified category applies with the aim of the CFDA to establish a better organized system for product naming and function description.

 

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