Medical Device Classification Catalog Adjusted, A Number of Devices Downgraded
On March 24, NMPA issues an announcement on adjusting some of the contents of the Medical Device Classification Catalog, adjusting the contents of the Medical Device Classification Catalog for 10 medical device products including clip devices on 02-15-14.
This adjustment is a routine dynamic adjustment. The working procedure for dynamic adjustment of medical device classification catalogue issued by the State NMPA in May 2021 makes it clear that the classification catalogue should be adjusted according to needs. In principle, the adjustment work shall not be less than once a year.
This adjustment is mainly a category reduction adjustment. Several products are reduced from category III to category II, which means that the management and registration threshold of relevant products will be relaxed in the future.
1
Category reduction products: focus on cardiovascular interventional devices
There are 7 degraded medical devices involved, including 02-15-14-clip device, 03-13-04-catheter disinfection connector, 03-13-12-puncture needle, 03-13-14-catheter sheath, 03-13-15-expander, 03-13-18-connecting valve and 03-13-25-extension tube. The management level is downgraded from class III to class II, including 6 cardiovascular interventional devices and one passive surgical device.
There are 17 effective registered products of clip devices, 10 puncture needles, 8 catheter disinfection connectors, 181 catheter sheaths, 13 expanders, 35 connecting valves and 11 extension tubes.
For the registered products whose management category is adjusted from class III to class II, the State Food and drug administration has made it clear that the medical device registration certificate will continue to be valid within the period of validity. If the registration is continued, the class II medical device registration certificate shall be issued after approval 6 months before the expiration of the registration certificate.
02
Intended use and product name adjustment
The adjustment of the classification catalogue of medical devices also involves the adjustment of expected uses and product names. The intended use of “13-01-05 metal fixation and cerclage device” is adjusted from “around the long bone, anchored on the long bone through wire or screw for fracture fixation” to “anchored on the bone through wire or screw for bone fixation or bone joint”.
The additional designation of Injectable Filler for Plastic Use exemplifies the addition of Recombinant Type III Humanized Collagen Lyophilized Fiber to the original Cross-linked Sodium Hyaluronate Gel for injection, Sodium Hyaluronate Gel for Injection, Collagen Implant, Polylactic Acid Filler for Injection with no change in management category.
03
Liquid, cream dressings (not supplied aseptically)
Upgrading to Class II
Among the 10 categories of medical devices adjusted this time, only one category of medical devices Liquid and Paste Dressings (non-sterile)”, has an upgraded management level, which is upgraded from Class I to Class II.
The number of valid filing products under this category is 5,092, including 5,070 domestic products and 22 imported products.
For the 10 categories of medical devices involved in the content adjustment this time, if the approval has been accepted but the approval has not been completed, the NMPA will approve it according to the original category, and the issued registration certificate will note the adjusted management category.
The adjustment of this classification list involves the declassification of a number of medical devices, which provides certain convenience for the registration and production of related products. You are also welcome to put forward your own opinions and views.
Source:Zhongcheng Medical
Please reach out to us for any questions via info@bradyknowsmedical.com
