The new catalogue, which becomes effective on August 1, 2018, is likely to have a significant impact on the registration, manufacturing, operation, and distribution of medical devices in China.
On September 4, the China Food and Drug Administration (CFDA) published an amendment to the Medical Device Classification Catalogue (New MD List) that simplifies the existing classification of medical devices in China.
This LawFlash discusses the characteristics of the New MD List and its implications for the registration, import, and use of medical devices in China.
CHARACTERISTICS OF THE NEW MD LIST
As compared to the 2002 Medical Device Classification Catalogue (Existing MD List), the architecture of the New MD List is more scientific, comprehensive, and user-friendly. The New MD List does the following:
- Reduces the number of device categories from 43 to 22 based on the medical devices’ functions and clinical uses. It also reclassifies the current 260 device types into 206 primary types and further subdivides the 206 primary types into 1,157 sub-types.
- Provides clearer guidance and product examples that enable companies to determine the level of regulatory control. For example, each catalogue of the New MD List contains a primary type, sub-type, device description, intended use, device examples, and classifications for Classes I, II, and III. It also includes 6,609 devices in the device example column, while the Existing MD List offers only 1,008 example devices.
- Downgrades the classification of 40 devices to Class II (e.g., infusion pumps for surgical instruments) or Class I (e.g., plate washers).
- Upgrades the classification of certain types of devices to Class III (e.g., alcohol swabs and active breathing coordinators).
- Includes 86 categories of clinical testing devices in Section 22. More importantly, the explanatory notes in Section 22 state that if a device is related to clinical testing but itself does not function as a medical device, the product is not considered a medical device. This article also lists some examples—such as transfer pipettes, common sampling tubes, common sampling cups, and common sample collection devices.
The New MD List does not, however, cover classification categories for in-vitro diagnostic (IVD) reagents. The classification of IVD reagents remains subject to the existing specialized IVD sub-catalogue issued by the CFDA in 2013, as well as other relevant CFDA notices.
IMPLICATIONS OF THE NEW MD LIST
We recommend that manufacturers, importers, and users of medical devices pay close attention to the New MD List because it will affect the registration and import of medical devices. Below is a list of considerations.
Initial Medical Device Registration or Filing
- Applications approved by the CFDA before August 1, 2018 will not be affected by the New MD List. However, if a Class I medical device filed with the CFDA under the Existing MD List has been upgraded to Class II or Class III under the New MD List, this product must be registered with the CFDA, rather than being filed, before a statutory deadline of August 31, 2019. We recommend that companies that own Class I medical devices review whether their products have been upgraded under the New MD List. If so, preparations should be made well in advance of the deadline given that CFDA registration of Class II and Class III medical devices is time consuming, as in-country testing and clinical trials generally are required.
- Applications submitted before August 1, 2018 but not yet approved by the CFDA will be reviewed based on the Existing MD List. Upon approval of the application, if the classification remains the same under the New MD List, the CFDA will issue a registration/filing certificate that states the product code under the New MD List. However, if the product classification has changed under the New MD List, a certificate will be issued that states the product code under the Existing MD List along with a note that includes the code under the New MD List.
- The New MD List will be used for all applications submitted to the CFDA on or after August 1, 2018.
Extensions of Existing Registrations or Filings
- Extension applications approved by the CFDA before August 1, 2018 will not be affected by the New MD List. The CFDA will issue a renewal certificate in accordance with the Existing MD List.
- Extension applications submitted before August 1, 2018 but not yet approved, as well as extension applications submitted on or after August 1, 2018, will use the New MD List. The CFDA will review the application and issue a renewal certificate in accordance with the New MD List.
- If an extension application for a product that has been downgraded under the New MD List is made on or after August 1, 2018, the registrant must apply with the CFDA for a registration extension or a Class I filing (if applicable) six months prior to expiration.
- If an extension application has been made for a product that is upgraded under the New MD List, while the existing registration or filing certificate remains valid, the registrant may apply with the CFDA for an extension. Such an extension could be granted up to August 31, 2019. After August 31, 2019, or at an earlier expiration date approved by the CFDA, the registrant must reregister the product in accordance with the New MD List.
Import and Use of Medical Devices
The New MD List becomes effective on August 1, 2018. Until that time, the Existing MD List will remain effective. However, many entities such as hospitals, pharmacological research and development institutions, and medical testing labs may import and use medical devices in China before August 1, 2018. The law is silent on whether CFDA and its local counterparts would refer to the New MD List before the effective date, especially for products whose classification is unclear under the Existing MD List but clear under the New MD List.
Although the New MD List is not yet effective from a legal perspective, it could represent the CFDA’s attitude toward the classification of medical devices in general. At this stage, the CFDA may use the New MD List as a reference when the classification of a particular product is not clear under the Existing MD List. We believe that this is a positive development—especially for products whose classification is unclear under the Existing MD List but clear under the New MD List. That said, local CFDA staff are now being trained on the New MD List, and the agency’s position regarding the use of the New MD List prior to its effective date has not been finalized.
We will continue to closely monitor developments in this area.
If you have any questions or would like more information on the issues discussed in this LawFlash, please contact any of the following Morgan Lewis lawyers: