In order to help and guide the registration applicant to prepare the application materials of registered products to meet the basic requirements of technical review, CMDE of NMPA recently issued two drafts for comments online. They are the Guideline for Registration and Review of Disposable Abdominal Puncture Device(Draft) and the Guideline for Special Registration and Review of Digital Technology of Positron Emission / X-ray Computed Tomography System(Draft). The comments should be submitted by October 21 and October 8, 2021 respectively.
It is a great opportunity to have your voices heard by NMPA reviewers and influence them to form a more practical guideline in the end. A thorough and realistic guidance document not only helps NMPA reviewers during their technical review process but also guides manufacturers to satisfy NMPA’s requirements. For more information about how to develop a feedback strategy or assistance in submitting your inputs, please contact info@inspirativemed.com.
Scope of Application
Guideline for Registration and Review of Disposable Abdominal Puncture Device
This guideline is applicable to the disposable abdominal puncture device (hereinafter referred to as the puncture device). This product is used to puncture the human abdominal wall tissue during laparoscopic surgery to provide a channel for the operation of surgical devices.
In order to ensure the air tightness during use, there are two design methods for common puncture device. One is to maintain pneumoperitoneum by relying on the sealing ring and mechanical valve at the head end of puncture casing. Its structure which is not the only type is shown in Figure 1 below:
(Figure 1)
One is used in combination with special pneumoperitoneum system. A stable pneumoperitoneum is maintained by recirculation through a tiny pressure nozzle within the puncture device to create an air-tight pressure barrier usually comparable to the intra-abdominal pressure of the patient (as shown in 2). For reusable abdominal puncture device and thoracic puncture device, refer to their applicable parts.
FIG. 2 Non – mechanical valve design puncture for maintaining pneumoperitoneum
Guideline for Special Registration and Review of Digital Technology of Positron Emission / X-ray Computed Tomography System
The guideline is applicable to the requirements related to the digital technology of PET/CT products. According to the Classification Catalogue for Medical Devices, this product belongs to medical imaging devices of category 06, with Class I product category of 17 combined functional fusion imaging devices and Class II product category of 02 Positron Emission/X-ray Computed Tomography System. This product is managed as Class III medical device.
