Q1: If have integral DDC product with lots of device (packaging) info in Modules 3.2.P.2.4 & P.7 can you simply x-ref to these sections for safety, tesing/CoA's, stability etc.
A1: Considering the definition of DDC product in China could be different with other countries, it is crucial to clarify the classification of DDC products in China first. According to current technical guideline for DDC registration, if the DDC is classified as a device-based product, DMF filing is not required for the packaging of the product, while if the DDC is classified as a drug-based product, DMF filing is applicable for packaging.
Additionally, it is also recommended that applicants determine whether the device/packaging combined in the DDC product is classified as a packaging product in China. We have encountered many cases where the classifications of a product differ between its country of origin and China.
If the device/packaging is indeed classified as a packaging product, when applying for DMF registration, applicants can refer to the data in Modules 3.2.P.2.4 and P.7 for sections related to safety, testing/CoA’s, and stability data. However, we strongly advise conducting a data completeness analysis as the data in Modules 3.2.P.2.4 and P.7 may not fully comply with DMF requirements in China.
On the other hand, if the device/packaging is classified as a medical device, the applicant should consider applying for medical device registration, or register the whole DDC product following the DDC registration guideline, which involves a classification determination procedure.
For further information, please do not hesitate to contact us and provide your specific situation.