On August 31, CFDA announced the new “Medical Device Classification Catalogue”. This new catalogue will be implemented on August 1ST, 2018. The revised medical device classification directory has significant implications for medical devices registrations or renewals. It is more robust and comprehensive as compared to its 2002 classificaiton version. We have summarized below the key points, revision background and comparision with the previous catalogue, and key contents of the new catalogue etc.
Here is the link for our comments this the new classification catalogue was first released as draft for feedback. https://chinameddevice.com/cfda-new-medical-device-classification-directory-will-be-released-soon/
The structure is not thorough, there are duplicates in sub categories.
Key information is missing which impact the standardization of registration review.
New products and new categories are not included. The catalogue cannot be updated in time. Classification lacks logic.
New catalogue VS Old 2002 catalogue
|New Version||2002 Version|
|Sub catalogue (Level I catalogue)|
|Level II Product category||Sub catalogue|
|Level III Product category||Product category|
|Product description||Product name example|
|Product name example|
|Content||New Version||2002 Version|
|# of Sub catalogue||22||43|
|# of Product category||206 Level I product categories|
1157 Level II product categories
|260 product categories|
|# of product name example||6609||1008|
|# of products that have been reduced to lower risk level||40|
New 22 Sub catalogues:
|Surgical instruments||01 surgical instruments with electronics (active)|
02 surgical instruments without electronics (passive)
03 nerve and vascular surgical instruments
04 orthopedic surgery-related devices
|Devices with electronics (active)||05 radiation therapy equipment|
06 medical imaging equipment
07 medical examination and monitoring equipment
08 respiratory, anesthesia and first-aid equipment.
09 physical therapy equipment
10 blood transfusion, dialysis and cardiopulmonary bypass equipment
11 medical equipment disinfection and sterilization equipment
12 active implant devices
|Devices without electronics (passive)||13 passive implant devices|
14 infusion, care and protective equipment
15 patient-carrying devices
|Devices by clinical departments||16 ophthalmic devices|
17 dental instruments
18 obstetrics and Gynecology, reproductive and contraceptive devices
|Others||19 medical rehabilitation devices|
20 Chinese medicine instruments
21 medical software
22 clinical testing devices
The Key Advantages of New Catalogue
Impacts for CFDA Registration
Before August 1st 2018, applicants whose CFDA certificates are approved will not be affected by the new classification. Meanwhile, the products that are included in classification revision will the certificate base on 2002 version catalogue.
After August 1st 2018, all the registration and reviewing should be corresponding with new catalogue. Product classification should be based on new catalogue during the certificate extension process.
Class I medical device filing
The filing notifications obtained before August 1st ,2018 are still valid. Applicants should apply for new registration if their product are up-classified.
After August 1st 2018, all the Class I medical devices should do the filing based on new catalogue.
Classification Code on Production and Operation license
The operating scope of newly issued medical device operating license and Class II medical equipment operating filing certificate should be divided in 2 parts: classification code of 2002 catalogue and classification code of new catalogue.
After August 1st 2018, the manufacturing scope of medical device production license and medical device manufacturing products registration form should be divided into 2 parts with highlight: classification code of 2002 catalogue and classification code of new catalogue.
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