At present, China has approximately 77,000 medical device registration certificates and 3.7 million medical equipment records, making the process of obtaining, tracking and managing classification documentation a rather large feat.
On September 4, 2017, in an effort to simplify the classification process, the China Food and Drug Administration (CFDA) introduced a new version of the “Medical Device Classification Catalog.” This revised catalog includes an updated ‘classification directory’ framework and will become effective beginning August 1, 2018.
Comparatively, the 2002 edition of the Medical Device Classification Catalog includes:
- 43 sub-catalogs
- 22 subdirectories
- 260 product categories
- 206 first-level product categories
- 1,157 secondary product categories
Whereas, the new version of the classification catalog includes the following (lesser) attributes:
- 22 sub-catalogs, categorized by medical device industry and clinical features
- sub-catalogs that consist of a first-class product category, secondary product category, product description, intended use, examples and a management category
- a process whereby product classification determinations are based on use case scenarios of a device
The architecture of the new catalog is far more scientific while at the same time, more realistic for everyday use by medical device manufacturers. For example, the catalog uses the U.S. Food & Drug Administration’s (FDA) clinical use and classification system, while also taking into account the EU Notified Body structural catalog as a reference (thus paring down 43 sub-catalogs to 22 sub-catalogs).
While much of the new catalog has been trimmed in contrast to the old version – such as the new option for high maturity products (with controllable risk) to transfer to a lower class management category – it should be noted that extensive information has also been added that is instructional and operational in nature.
Important Timelines and Factors
- For CFDA classification applications submitted after August 1, 2018, new classification rules will apply.
- If a device manufacturer’s product classification will fall into a higher category under the new catalog, the manufacturer will be required to apply for a new CFDA registration.
- If a device manufacturer’s product classification is lowered as a result of the new classification catalog, the registering party must apply for a Class I notification or a six month extension from the device’s date of expiration.
- Device manufacturers registered with the CFDA should determine whether their devices, under the new catalog, may require re-registration early-on so they may appropriately manage the new classification process.
The above considerations for Chinese medical device manufacturers are just a few that must be carefully managed prior to the mandatory implementation date of August 1, 2018.
NAMSA invites you to contact us at email@example.com to discuss you medical device development efforts in China, including regulatory impacts that may impact your intended commercialization strategies. More information on NAMSA’s regulatory services can also be found by clicking here.