NMPA issued the “Guideline of Drug-coated Balloon Dilatation Catheter (draft)” today on June 22, 2022, collecting public opinions. Feedbacks need to be submitted by July 22, 2022.

Referring to “ASTM F3320-18 Standard Guide for Coating Characterization of Drug Coated Balloons”, the proposed guideline is trying to keep up with international standards.

Highlights of the Guideline

Registration Units

The registration units of drug-coated balloon dilatation catheter shall be based on the “Guideline for Registration Units of Medical Devices”, and focuses on factors such as the technical principle, structural composition, performance indicators and scope of application of the product. The below principles shall be followed:

Composition materials

Identify basic information such as common name/chemical name, trade name/brand, material standard (if applicable) and material supplier of all components of the product, including solder, adhesive, colorant, etc. used in the manufacturing process.

It is recommended that the constituent materials of the product be provided in the form of a list and correspond one-to-one with the names of the parts identified in the product structure diagram.

If the constituent materials of the product are mixtures, it is also necessary to clarify the components and content of the mixed materials.

If the component structure is designed with a layered/segmented structure, for example, the conduit body is designed with a multi-layered structure and the materials of different segments are different, it needs to be described layer by layer/segment by segment.

For the specific requirements on the drug, drug-loaded matrix and excipients, please email info@ChinaMedDevice.com.

Research materials

Research materials shall include

• Product performance research

Apart from the general requirements listed in the “Guideline for Balloon Dilation Catheters Registration”, the following research materials should also be provided:

1. Research on drugs: identification and purity of drugs, drug loading, types and contents of drug degradation products/impurities, drug release studies in vitro, solvent residues, etc.
2. Degradation characteristics of the degradable matrix and the safety of the degradation products (if applicable)
3. Selection basis of drug dose density
4. Selection basis of drug-loading matrix (if applicable)
5. Interactions between medical devices and drugs
6. Characterization of drug coating distribution

• Biocompatibility evaluation studies
• Biosafety research
• Research on sterilization process
• Product shelf life and packaging research
• Preclinical animal testing

Clinical evaluation

1. Clinical evaluation data should be submitted in accordance with the “Guideline for Clinical Evaluation of Medical Devices”.
2. For necessity of clinical trial, refer to the “Guideline for Decision-making on Conducting Clinical Trials of Medical Devices”
3. For design of clinical trials, refer to the “Guideline for the Design of Clinical Trials of Medical Devices”
4. If the registration applicant has overseas clinical trial data, relevant materials shall be submitted based on the “Guideline for Acceptance of Overseas Clinical Trial Data of Medical Device”

For the English version of the full guideline, with annexes on performance verification and particle characterization, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.