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/
Key points:
- Revised classification criteria and categories
- Risk level of 40 categories products have been reduced (Class III⇒Class II, Class II⇒Class I)
- Newly added more than 5,000 product name examples, 6,609 product name examples in the new catalogue vs the 1,008 in the original 2002 classification catalogue
- Clinical indications and product descriptions are added and expanded in details.
Revision Background
- The previous catalogue was released in 2002, fifteen years ago. The 2002 version catalogue cannot meet the needs anymore:
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.
- Medical device classification is the foundation of medical device supervision on registration, production, operating and usage.
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 |
| Clinical Indication |
Classification |
| Product name example |
|
| Classification |
|
| 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
- 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 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.
About China Med Device, LLC (CMD) CMD provides turn-key solution for Western medtech companies with regulatory and commercialization services. CMD helps its clients accelerate China entry and growth by offering: market Intelligence and research; CFDA regulatory services (premarket submission, clinical evaluation, clinical trial design & management, post market compliance and legal representation), and other commercial services.
FREE Situational Review: Are you exploring entry into China? Let us help you develop a strategy that optimizes your resources and objectives. Email us info@ChinaMedDevice.com and check out additional resources on our website: www.ChinaMedDevice.com
------------------------------
Grace Fu Palma
China Med Device, LLC
MA, U.S.
gpalma@chinameddevice.com978-390-4453
www.chinameddevice.com------------------------------