CFDA announced the new “Medical Device Classification Catalogue”!

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CFDA announced the new “Medical Device Classification Catalogue”!

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.

 


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