Grace Fu Palma, China Med Device
The China Food and Drug Administration (CFDA) recently unveiled its new “Medical Device Classification Catalogue” – which has significant implications for medical devices registrations or renewals.
The new catalog, announced Aug. 31 after a previous draft release and feedback period, goes into effect in less than a year – on Aug. 1, 2018.
The revised medical device classification directory is more robust and comprehensive as compared to its 2002 classification version. Here are the major things you need to know about it:
- Revised classification criteria and categories. The risk level of 40 categories products has been reduced (Class III down to Class II, Class II down to Class I).
- Added more than 5,000 product name examples. There are 6,609 product name examples in the new catalog, versus the 1,008 in the original 2002 classification catalog.
- Clinical indications and product descriptions are added and expanded in detail.
The previous catalog was released in 2002, 15 years ago. The 2002 version can no longer meet China’s regulatory needs:
- The structure is not thorough, there are duplicates in subcategories.
- Key information is missing which impact the standardization of registration review.
- New products and new categories are not included. The catalog cannot be updated in time. Classification lacks logic.
The situation has been a problem because medical device classification is the foundation of medical device supervision on registration, production, operating and usage.
New catalog versus old 2002 catalog
|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|
There are 22 new sub-catalogs
|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 the new catalog
- 3-level structure: more logical and closer to clinical practice
- Adding key info: adding product description and clinical indication for the standardization and unity of different parties.
- Increasing product name examples: boarder coverage.
- Reducing the classification level of 40 categories products: decrease the percentage of Class III medical devices
Impacts for CFDA registration
Before Aug. 1, 2018, applicants whose CFDA certificates are approved will not be affected by the new classification. After Aug. 1, 2018, all the registration and reviewing should correspond with new catalogue. Product classifications should be based on the new catalogue during the certificate extension process.
Class I medical device filing
The filing notifications obtained before Aug. 1 ,2018 are still valid. Applicants should apply for new registration if their product are up-classified. After Aug. 1, 2018, all Class I medical devices should be filed 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 two parts: classification code of 2002 catalogue and classification code of new catalogue.
After Aug. 1, 2018, the manufacturing scope of medical device production license and medical device manufacturing products registration form should be divided into two parts, highlighting the classification code of the 2002 catalogue and classification code of the new catalogue.
Grace Fu Palma is founder and CEO of Boston-based China Med Device, a firm specializing in commercialization and funding for U.S. medtech companies entering China.