EMERGO SUMMARY OF KEY POINTS:

• A new China FDA classification catalog may require new registrations for some medical device market applicants.
• Changes in classification requirements in the new catalog may result in up-classification (and re-registration) of some Class I medical devices in China.
• The new classification catalog will be implemented on August 1, 2018.

Medical device regulators at the China Food and Drug Administration (CFDA) plan to implement a new medical device classification catalog in August 2018.

According to Emergo consultants in Hong Kong, the new catalog’s (link in Chinese) implementation date is set for August 1, 2018. Several significant changes to device coding and classification processes will affect Chinese market applicants once CFDA begins utilizing the new catalog.

CFDA registrants should be aware that the new catalog will apply only to medical devices; CFDA will continue using existing classification and coding systems for IVD products. Furthermore, once the new catalog comes into force, all previous classification catalogs for Class II and III devices will become obsolete. Class I device classification will still rely not only on the new catalog but also other resources currently available, however.

New product code formatting

The 2018 catalog will comprise 22 sub-catalogs such as primary device type, secondary device type, description, intended use and classification. Under the current system, medical device product codes follow the format “68XX-XX.” Starting in August 2018, though, sub-catalog data will affect product code formatting for devices: Product codes will be created using a sub-catalog number, primary device type number and secondary device type number, creating an “XX-XX” format.

As an example, CFDA currently assigns surgical lamps a product code of 6854-13; in the new catalog, surgical lamps are assigned a sub-catalog number of 01 and a primary device type number of 08, resulting in a product code of “01-08 surgical illumination system.”

(The new catalog helpfully includes a table to compare current and new product coding formats.)

Implications for CFDA registrations

Chinese medical device market applicants whose CFDA submissions are approved before the new catalog’s August 2018 implementation date will not be affected by the new catalog’s product coding and classification requirements.

CFDA reviewers will use the current catalog also for applications submitted before the August 2018 implementation date but not yet approved; for these registrants, if there is no change in the device classification between the old and new catalogs, certificates will be issued using new classification and product codes. However, if there is a change in such classification, certificates will be issued using old classification and product codes along with notes that include new catalog codes.

For CFDA registration applications submitted on or after the August 2018 deadline, the new catalog will fully apply.

How CFDA registration extensions will be affected

Chinese regulators will treat registration extensions applications in similar fashion regarding the new catalog:

• Extensions approved by CFDA before the August 2018 implementation date will be based on the classification catalog currently in use.
• Extension applications submitted prior to August 1, 2018 but still awaiting approval by that date will undergo CFDA review according to the catalog currently in use. Certifications will be issued with new product codes for applications wherein there are no classification changes between old and new catalogs; for devices with changes in their classifications, certifications will include old product codes but also notations for product codes from the new catalog.
• Extension applications filed after August 1, 2018 will be reviewed according to the new catalog.

CFDA registrants should be aware that classification changes to their devices under the new catalog may require re-registration with Chinese authorities. If new catalog requirements lower a device’s classification, the registrant should apply for Class I notification or an extension six months prior to expiration. If a device’s classification is raised according to the new catalog, however, the manufacturer must apply for a new registration with CFDA. In such cases of up-classification, submitting a new registration application before your current CFDA certificate expires allows you to apply for an extension to your original registration; this extension will remain valid until no later than August 31, 2019.

Class I medical device issues

CFDA Class I notifications obtained before August 1, 2018 will remain valid once the new catalog is implemented. But in instances where a device is up-classified according to new catalog criteria, companies will have to apply for new CFDA registrations; August 31, 2019 is the deadline for such registrations to be complete.

Following implementation of the new CFDA classification catalog next year, registrants should utilize the following resources to determine whether their devices qualify for Class I notification:

• The new CFDA classification catalog
• CFDA Class I medical device catalog (link in Chinese)
• CFDA Class I notification implementation details (link in Chinese)

CFDA Class I medical device registrants should keep in mind that up-classifications may prove especially challenging for them, as Class II and III registrations require in-country testing and clinical trial data.

Emergo consultants are currently seeking additional information on how the new classification catalog will affect CFDA registrants.

Related information on Chinese medical device regulations:

• CFDA registration consulting for medical device companies
• China in-country Agent Representation for foreign medical device companies
• CFDA medical device clinical and testing assessment and support
• Whitepaper: Chinese medical device regulations
• Regulatory process chart: CFDA registration requirements