On September 7, 2021, the NMPA (National Medical Products Administration) announced (No.68-2021) the technical review guideline for the clinical evaluation of intravascular catheter products in comparison with its predicate devices.
- Predicate devices must be sold in the market already, and should be similiar to the applicant product in terms of intended use, technical characteristics and biological characteristics.
- The guideline’s objective is to ensure the clinical data of the predicate device is being used reasonably as supporting evidence to prove the product is safe and effective for clinical use.
- Basic requirements of the clinical evaluation in comparison with predicate devices including but not limited to the following:
- Anatomic sites for catheters should be described and compared in detail.
- Product designs should be compared in detail because the outcome might be different in terms of the function. For example, a specially designed head-end configuration is used to reduce vascular damage.
- Comparison of the basic structure in terms of number and size of different cavities, the types of joint, the position and number of holes in the end of the catheters and the coating.
- Production process and manufacturing materials: Raw materials that may have direct or indirect contact with the human body should be compared.
- Performance Requirements: Based on the product category, intravascular catheters should comply with the mandatory industrial standard YY0285, and take the corresponding technical requirements of the product design features as reference.
- According to Order 739, clinical trials can be exempted if the safety and effectiveness of medical devices can be proven by other non-clinical evaluation studies such as existing clinical data of predicate devices in the market, clinical evaluation, etc.
Read our blog post about the clinical trial exemption list for medical devices and IVD reagents recently published by the NMPA in accordance with Order 47 and Order 48 respectively.
By Judith Sun and Jacky Li. Contact Cisema if you would like to learn more.