What is a classification determination?
Classification Determination is a process to submit a dossier to the NMPA to determine
1) whether a product is a device;
2) if the product is a device, what is the risk level and category code of the device.
When is a classification determination needed?
Medical Devices and IVDs are regulated in three classes in term of risk levels in China. There is also a three-level category code to show to the specific field of use (e.g. orthopedics, dressing, etc.). The category code system is fully described in the Category List.
Both class and category must be determined before the registration submission. Due to the limited entries in the Category List, it is often to see that a device does not fill into any of existing category in the Category List. In this case, to avoid the immediate rejection of the submission, it is recommended to run a classification determination process while preparing the dossier.
Classification determination is also extremely important for borderline products. Some products regulated as medical devices in the home country are NOT necessarily a medical device in China. For example, we have justified a dressing products as medical device in Europe and the US to be a hygiene product in China. Also some non-medical device products in the home country can be treated as medical devices in China. For example, eye drops including hyaluronic acid are considered as drugs in China. To develop a successful marketing strategy in China, the manufacturer must identify the borderline product correctly.
How is the classification determination process to be done?
The product does not need to be approved in the home-country.
The application dossier including product description, product prototype photo, IFU, label, technical specifications and other information must be prepared. No notarization is needed.
The dossier submitted to the NMPA Standard Regulation Committee online.
NMPA does not charge any administration fee.
The NMPA shall give a feedback of the dossier on unclear topics. And the manufacturer shall provide additional information with supporting material to the NMPA.
The final results shall be available in the online system after the Standard Committee passes the decision to the NMPA project department, who approves it.
As the review time is not regulated by any guidelines, the waiting time for the whole process varies dramatically. We have seen reviewing time from 2 months to 6 months.
Therefore, it is better to prepare this process earlier during the registration process.
Why to choose JMEDTEC to help you with the classification determination?
JMedTec has the professional team to construct the dossier information into the best need for borderline products. For example, we have managed to justify a European medical device to be considered as hygiene product in China to fit the best need of the marketing strategy of the manufacturer.
JMedTec also keeps a good and close communication with the Standard committee to reduce the waiting time as much as possible.
Please contact us for further help at email@example.com.