September 14, 2017
(Image via incompliancemag.com)
On September 4th 2017, China Food and Drug Administration (CFDA) officially published the new revision of "Medical Device Classification Catalog". It will be implemented from August 1, 2018.
The current catalog of medical devices was published in 2002. However, there are some existing problems in the current catalog, such as the classification not being detailed, so the catalog framework couldn't meet the industry and regulatory requirements. Besides, the current catalog lacks product description, intended use and other key information. Moreover, because of the lack of the dynamic adjustment mechanism, the innovative medical devices cannot reasonably be classified into appropriate categories. Because of all these reasons, CFDA decided to revise the catalog of medical devices.
The new "classification catalog" refers to the US clinical-oriented classification system, and refers to the EU classification structure and there are 3 major changes, as follows:
1. The 43 sub-catalogs in the current catalog are integrated into 22 sub-catalogs based on the technical and clinical use of medical device technology. The sub-catalog includes a primary product category, a secondary product category, a product description, an intended use, an example of product name, and a management category.
2. The 260 product categories are organized into 206 primary product categories and 1157 secondary product categories. New catalog is a three-level catalog hierarchy: sub-catalog, primary category, and secondary category.
3. There were more than 2,000 intended uses and product descriptions that were added. The example number of product name expanded to 6609 from 1008 examples.
When determining the product classification, you should consider your product with the product description, intended use and name examples in the new catalog of medical device at the same time for a comprehensive decision.
The code rule of new catalog:
For example, the current classification number of Proton Therapy System is 6832-01, but the number becomes 05-01-02 in the new medical device catalog. “05” is the sub-category of the Radiology device; the current classification number of Dermal Filler Injection is 6846-01, but the number becomes 13-09-02 in the new medical device catalog. “13” is the sub-category of the non-active implantable device.
The risk levels of some product categories changed, some categories have been changed from Class III to Class II, some categories have been down reduced down to Class I from Class II, while some categories will no longer be classified as a medical device.
For example, a non-absorbable medical dressing (for non-chronic wounds, contacting with the dermis layer/hypodermis), which was originally under Class III, is now under Class II. If your company would like to know the new risk level of own products, please contact us!
To let the medical device industry adapt to the new catalog, the CFDA’s timeline will allow for the eventual transition to the new classification system, before its full implementation. During this time, the industry will be required to provide both the old and the new classification number for Post-Market Surveillance, Production and Quality Management processes. CFDA will also provide the new “classification catalog” training to guide the regulatory authorities and manufacturers to be able to comply with the revised classification system.