How is device incorporating a medicinal substance defined in China?
According to the relevant guidelines published in 2009, device incorporating a medicinal substance is the novel medical device composed of both medicinal substance and medical, which functions mainly by the device part.
Some examples are drug-eluting stents, catheters with antibacterial coating, condom with drug, and intra-uterine device with drugs.
The registration review process shall be led by the Center for Medical Device Evaluation (CMDE) of the NMPA, who shall involve the Center for Drug Evaluation for joined review.
How is the registration of device incorporating a medicinal substance done in China?
Currently, imported device incorporating a medicinal substance must be registered first in the home-country before entering China. Also, the medicinal substance shall be also registered in China before the device can apply for the registration.
Due to the novel characteristics of the device-drug combination products, the NMPA requires a process of Product Type Determination before the registration process in China. The administration service office will form an expert team together with CDE and CMDE to confirm the product type. The decision letter shall be sent to the applicant within 20 working days after receiving the application.
Like normal medical devices, the device incorporating a medicinal substance must also perform the lab tests according to the Product Technical Requirements (PTR) in a NMPA-accredited testing lab in China. Besides the general requirements for devices, the PTR shall include the relevant qualitative or quantitative specifications of the medicinal substance. How the release of the drug substance in the device is controlled must be also included if applicable. In case of any special requirements of drugs in the storage and transport, it shall be clearly defined in the PTR.
The biocompatibility tests are not required to be repeated in Chinese lab if the tests were done abroad in a GLP-accredited lab. It is usually required to provide the local drug tolerance data, such as genotoxicity, long-term toxicity, carcinogenicity and drug dependence, etc.
It is usually seen that the clinical evaluation of a device incorporating a medicinal substance is done via clinical trial in China.
Manufacturers shall be prepared to conduct a full clinical trial in China for such a device.
Besides the general requirements for the devices, the device incorporating a medicinal substance shall provide more information regarding to the medicinal substance, including but not limited to:
Information on the source, and the quality of the drug;
Quality stability data of the drug administration material;
Data about pharmacology, pharmatoxicology and pharmacokinetics;
Adverse drug events of the drug;
Manufacturing process of the drug and the device and the research data of the drug and device interaction;
Research data on the drug strength;
Research data on the storage and shelf life.
Main challenges for the registration of device incorporating a medicinal substance
Why choose JMedTec to assist you with the registration for device incorporating a medicinal substance?
JMedTec has expert consultant as the member in the Work Group for DDC new regulation establishment and can update you the information about DDC approval.
With both inhouse device and pharma teams, JMedTec is specially strong in drug-device combinations.