The First Step of Drug-Device Combination Product Registration in China----Jurisdictional Designation

Drug-device combination products are novel medical products that combined drugs and devices. The first and most important work is to decide whether the product is managed as medical device or drug when starting the CFDA registration in China.
There are some specific procedures of jurisdictional designation for Drug-Device Combination Product under CFDA regulations.

What is a Drug-Device Combination Product?

The Drug-Device Combination Product is a product composed of any combination of a drug and a device, which is physically combined or mixed and produced as a single entity according to Notification on Matters Concerning Registration of Drug and Medical Device Combination Products (SFDA, No.16, 2009).

How to define your Drug-Device Combination Product?

Compared with conventional medical devices, it is more complex and more date requirements to register the Drug-Device Combination Product. If drug plays the leading role, the combination product shall apply for drug registration. Otherwise, it shall apply for medical device registration. Such as:

Procedures of Jurisdictional Designation

Documents Preparation: Explanation and relevant supporting materials of the product to facilitate making decision whether the product is registered as a drug or a medical device.

Liable Governmental Authority: Administrative Processing Service Center (APSC) of the China Food and Drug Administration (CFDA); Center of Drug Evaluation (CDE); Center of Medical Device Evaluation (CMDE).

Timeline: Within 20 business days

However, the application will not be accepted if your product meets one of the following conditions:

The combination products have not been approved for sale in the export country (region).
The drug in a combination product has not been registered in China or has not been approved for sale in the country (region) of manufacturer.

Application supporting documents preparation

1. Description of structure and composition

Applicant shall describe the components and combination models completely to make audit/expert panel have enough information to understand the product.

2. Intended use

Applicant shall explain the intended use of product concisely and clearly, include total intended use of whole product and each component’s intended use. For example, the total intended use of drug-eluting stent consisted of drug and stent is to improve the lumen diameter of coronary artery and prevent rest enosis. Stent is used for improving the artery diameter, and drug is used for preventing restenosis.

3. Action mode

The mode of action refers to the way that product achieves intended use. For single product, only one action way in generally, which always determine the manage attribute of product. For combination product, there is more than one type of actions. The contribution of each type to total intended use is different, and the main action type will determine the manage attribute. So applicant shall list all known actions, and indicate which action is main with reason.
Staying with the drug-eluting stent example, stent opens the vessel by physical action, and drug’s action is immunosuppression. The main action of the product is physical action of stent, so the product is managed as medical device.

4. Usage and Duration

Applicant shall declare the usage, frequency and duration of the product, and the proportion of each component in life span of whole product. Applicant also shall clearly show the dosage of drug.

5. Report of process and results of development

Applicant shall summarize all research data as far as possible, including animal test, to help panel to decide which action is main.

6. Manufacturing procedure description

Applicant shall describe the manufacturing procedure briefly, including source of each component, etc.

7. Description of related product and supervision

If there are similar or related products in market, applicant shall introduce the products and their managed attribute in brief for panel reference.

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