Ultrasound soft tissue surgical equipment in China have a newly amended technical review guidelines issued for the preparation of registration dossiers moving forward. The guidelines were announced by the by the Center for Medical Device Evaluation (CMDE) on March 31, 2023, and came to effect immediately.
Scope of product
The guidelines are applicable to ultrasound soft tissue surgical equipment products for sealing blood vessels of up to 5mm in diameters. For products where ultrasound is used in conjunction with other energy outputs, the section about ultrasound of this guideline may also be used as a reference. If the product does not come with a multi-use shear or curved multi-use shear design at the tip, a comparative analysis should be carried out before deciding whether the product would fall under the scope of this set of guidelines. A brief description of the product features and working principles are provided in Annex 1 of the document.
According to the 2017 edition of the Classification Catalogue of Medical Devices, the ultrasound soft tissue surgical equipment products is managed under product category III with 01-01-01 as the product classification code.
It is recommended that the main unit, transducer and cutter head are either registered as one unit, or the main unit and cutter head are registered separately. The transducer is an essential component which cannot be registered separately, however, can be registered with either the main unit or cutter head.
A registration unit can contain more than one model of the system, but there should only be one mainframe to operate with all other accessories.
Types of tests and requirements
According to the guidelines, three tests are available for ultrasound soft tissues surgical equipment in China for sealing vessels up to 3mm and/or 5mm in diameters:
- In vitro vascular burst pressure test
- Acute animal test
- Chronic animal test
The guidelines also address the product technical requirements, packaging information, other tests and studies, as well as standards to refer to such as the YY/T 1750 “Ultrasonic soft tissue cutting and haemostasis surgical equipment” for performance indicators. If applicable, a cybersecurity study should also be submitted in accordance with the requirements of the Guidelines for the Review of Medical Device Cybersecurity Registrations.
Read the original CMDE announcement on the newly amended technical review guidelines for ultrasound soft tissue surgical equipment in China or discover our services for medical device manufacturers.