Medical endoscopes are typical interdisciplinary products covering optical imaging, mechanical structure, materials, biological evaluation, reprocessing technology and clinical application scenarios. For registration applicants, the difficulty of endoscope registration lies not only in compiling application documents, but in establishing a complete evidence chain complying with product intended use and risk characteristics to pass technical review.
According to current published review frameworks, NMPA and CMDE have issued corresponding guidelines or key review points for invasive rigid optical endoscopes, electronic upper gastrointestinal endoscopes, flexible fiber endoscopes and laparoscopic surgical systems. It indicates that endoscope registration now focuses more on product definition, systematic attributes and application scenarios. For teams conducting registration consultation, Class III device registration or clinical evaluation, correct pathway assessment at an early stage effectively reduces rework costs.
Many project teams raise a core question at project initiation: whether a medical endoscope is classified as Class II or Class III medical device. A reliable conclusion cannot be given directly; instead, basic judgment factors need to be confirmed first: rigid, flexible or capsule type, optical or electronic configuration, registration as a standalone endoscope or a complete system, access route via natural orifice, penetration into sterile tissues, and built-in active functions such as image processing, illumination or navigation. Different results directly determine classification definition, registration unit division and subsequent document preparation.
Published regulatory guidelines clearly adopt differentiated review principles. Rigid optical endoscopes for natural orifice use, invasive rigid optical endoscopes, flexible fiber endoscopes, electronic endoscopes and laparoscopic surgical systems registered as complete sets differ vastly in applicable guidelines, review focuses and document frameworks. Wrong judgment at this stage usually requires full revision of the entire application dossier rather than partial modification.
For endoscope projects, priority should not be given to drafting application documents but completing classification determination and registration unit planning. First, confirm the regulatory classification matching the product’s clinical application; second, decide on standalone registration or system-based registration. For laparoscopic endoscopic surgical systems, the review covers not only endoscope bodies but overall system composition, interface configuration, risk management and supporting verification.
In addition, judgments on model discrepancies including shaft length, viewing direction angle, field-of-view angle, working channel, insertion tube structure and imaging mode shall be finalized by mid-R&D to distinguish items eligible for one registration unit from those requiring separate applications. Late unit splitting prior to submission will adversely affect testing, validation and dossier compilation.
The core of endoscope technical review is never limited to image definition, but the sustainable, stable and safe application of products under intended clinical scenarios. Relevant standards specify optical indicators, mechanical properties and general requirements for rigid endoscopes, while verification documents for flexible fiber and electronic endoscopes shall be prepared targeting practical risks such as insertability, bending property, image quality, tightness and durability.
Four major assessment items are commonly highlighted in actual projects: first, imaging indicators including field of view, resolution, image uniformity and color reproduction; second, structural and operational performances, especially the diameter of insertion tube, bending performance, working channel, sealing property and durability of flexible endoscopes; third, reprocessing verification covering cleaning, disinfection and sterilization; fourth, systemic compliance. Where endoscopes are assembled with image processors, light sources, camera units or software modules into an integrated system, electrical safety, EMC, software verification and usability engineering will also be examined.
In project management, these specifications indicate that quality management system control shall be introduced at prototype development instead of supplementary document preparation before testing or registration. Most supplementary data requests arise from missing R&D and verification records rather than insufficient technical responses.
The selection of clinical evaluation for medical endoscopes shall be formulated in accordance with prevailing clinical evaluation framework rather than empirical judgment. To decide whether clinical trials are required, confirm first if the product falls within the exemption catalogue, then verify whether discrepancies from predicate devices can be fully justified by non-clinical data. The key challenge for endoscope projects is not identifying the predicate comparison pathway, but gathering complete documents on discrepancy verification, reprocessing and product performance.
Under current review rules, mature products with consistent intended use as marketed counterparts whose variations are limited to specifications, structural details, partial materials or optimized parameters qualify for predicate comparison or clinical exemption, provided such differences are verified via performance testing, reprocessing validation, biological evaluation or animal tests. In contrast, products adopting innovative imaging principles, adding core new functions or expanding indications with undemonstrable discrepancies via non-clinical evidence shall arrange clinical trial assessment in advance.
It should be noted that clinical evaluation is not an independent section but the outcome of well-performed classification, registration unit partition, performance verification and reprocessing research. Comprehensive upstream evidence facilitates definite downstream pathway selection.
The following defects frequently occur in endoscope registration projects, which seldom exist individually but exert cascading impacts on classification determination, verification scheme formulation and clinical evaluation route selection.
Applicants preparing for medical endoscope registration are recommended to finish the following preparations in advance. First, define product scope to confirm whether it refers to endoscope body, complete system or accessories, and clarify invasiveness, active characteristics and reusability. Second, confirm registration unit division and applicable standards to avoid inconsistency between test scheme and registration application later. Arrange performance verification and reprocessing validation synchronously instead of leaving cleaning, disinfection, sterilization, sealing and durability tests to the final stage. Evaluate clinical evaluation pathway as early as possible since dossier requirements differ greatly among catalogue exemption, predicate comparison and clinical trial.
For products with ambiguous classification, unclear systematic features or insufficient discrepancy data, apply for regulatory consultation at key milestones. Consistent technical logic established in early development effectively reduces supplementary data and rework risks.
Focusing on medical endoscope registration projects, Deda Medical provides customized services tailored to product development phases and project objectives, including classification consultation and registration roadmap planning, registration unit division and applicable standard screening, compilation of product technical requirements and instructions for use, predicate-based clinical evaluation and discrepancy evidence collation, clinical trial protocol design when necessary, reprocessing validation and response to review supplementary requests, as well as quality system coaching linking R&D and production.
For endoscope projects, risk mitigation rarely relies on ad-hoc document supplementation, but the establishment of consistent logical framework covering R&D, verification, registration and quality system. Early setup of such framework ensures smooth subsequent registration submission.
The challenges of medical endoscope registration stem not from complicated product denomination, but ambiguous product definition, stringent evidence chain requirements and systematic review criteria. Accurate classification, rational registration unit setting, complete performance and reprocessing verification, and appropriate clinical evaluation pathway determine project efficiency and review stability.
For ongoing rigid, flexible or electronic endoscope projects, regulatory planning, verification design and dossier arrangement shall be arranged synchronously at project initiation and prototype phase rather than postponed till late R&D stage. Based on specific product conditions, Deda Medical assists in classification and registration route assessment, optimizes clinical evaluation and review solutions, and facilitates compliant market access from product development.
This document is compiled based on the following publicly released documents and standards.
5. Catalogue of Published Technical Review Guidelines for Medical Device Registration issued by NMPA
6. YY 0068.1-2008, Medical Endoscope - Rigid Endoscope - Part 1: Optical Properties and Test Methods
7. YY/T 1028-2023, Medical Endoscopes - Fiber Endoscopes
8. YY/T 1587-2018, Medical Endoscopes - Electronic Endoscopes
