In order to strengthen the supervision and guidance of the registration for medical device and further improve the quality of registration review, NMPA has published a new guidance document focusing on equivalence demonstration in clinical evaluation report of intravascular catheters. This does not include independent diagnostic or therapeutic functions catheters, such as vascular balloon dilatation catheters.
According to the guidance document, when comparing intravascular catheter products with predicate device, the predicate device should have been legally marketed in China and has same intended use and similar technical characteristics. The predicate device with higher homogeneity should be selected in aspects to intended use, technical characteristics, and biological characteristics.
The specific comparison items between subject and predicate device should follow the requirements in the "Technical Reviewing Guidance for Clinical Evaluation of Medical Devices", and stakehodlers should pay attention to the following items:
- Basic principles: (We need to specify and compare the anatomical parts of the catheters; also focus on the anatomical parts that the tip of the comparing catheter reaches. The principle of realization of the function should also be compared in detail) ;
- Structure and composition.
- Production process and manufacturing materials (The raw materials that directly or indirectly contact the human body should be compared);
- Performance requirements;
- Scopes of application, including population, applicable body parts, contact method with human body, indications, applicable stage and degree of disease, use environments.
- Method of use (We should pay attention to the differences in pretreatment methods used in different catheters);
- Precautions and warnings;
- Instruction for Use.
After detailed comparison between subject and predicate devices, all differences should be analyzed individually with supporting information. Corresponding non-clinical or clinical evidence should be submitted to the Authority to prove that the differences will not cause any adverse effect on the clinical use of the product.
Most intravascular catheters are widely used in clinical applications and in large quantities. Meanwhile, the product design is relatively mature. Any difference found during comparison which might not be the faced by a single product, but other similar products with same characteristics might face as well. Therefore, in addition to searching the clinical data of the predicate device, it is recommended to collect data of similar products with the same characteristics to support the clinical safety and effectiveness of the subject device.
Technical Reviewing Guidance for the Equivalence Demonstration in Clinical Evaluation Report of Intravascular Catheters (No. 68 of 2021)