On March 28, 2018, the State Food and Drug Administration issued a guideline circular. The following are the names and applicable scope of 1 guideline. For reference:

   Hard optical endoscope (invasive) registration technical review guidelines

   Scope of application: This guideline applies to invasive rigid optical endoscopes. It mainly enters the human body through invasive methods rather than through the natural channels of the human body.For example: abdominal endoscopy, arthroscopy, disc endoscopy, thoracic endoscopy, etc. Its purpose is to observe the image during an examination or surgery in a medical environment.The rigid optical endoscope is a rigid endoscope that includes a transmission illumination optical path and an optical imaging system. The external illumination light can enter the human body through the illumination light path. The condition in the patient can be externally imaged by the imaging system or visually observed by the doctor directly.A rigid endoscope is an endoscope in which the endoscope enters the human body and cannot bend along a natural orifice or a created surgical incision or other instrument channel.

   In clinical applications, a soft endoscope is opposed to a rigid endoscope; an electronic endoscope is opposed to an optical endoscope.Soft endoscpoes and electronic endoscopes are not in the scope of this guideline because imaging principles and technical points are different from those of optical endoscopes. In addition, this guideline does not apply to tubes or tubes that do not contain optical imaging systems.

   The following types of products can refer to this guiding principle, but this principle cannot cover all technical review requirements for it, but also need to add relevant requirements depending on the actual situation, such as:(1) Electrosurgical endoscopes need to increase considerations for high-frequency applications in product design, verification, and quality control; (2) Products with additional functions such as displays need additional functions and components. Safety and effectiveness are considered;(3) Disposable aseptically packaged products have differences in terms of biocompatibility, expiration date, sterilization, and packaging from reusable rigid optical endoscopes that are commonly used. Similar individualized differences are not discussed in detail within the scope of this guideline, and specific issues should be specific analyzed.