Preamble

The purpose of this guideline is to provide reference for the technical review department to review the registration information of corneal topographer, and also used to guide the applicant to prepare and write the registration information.

This guideline is a general requirement for corneal topographer, the applicant for registration should determine whether the content is applicable according to the specific characteristics of the product, if not, it is necessary to specify the reasons and the corresponding scientific basis, and according to the specific characteristics of the product to enrich and refine the content of the registration information.

This guideline is for registration applicants and reviewers to use the guidance document, does not involve administrative matters such as registration approval, and is not mandatory as a law, if there are other methods that can meet the regulatory requirements, can also be used, but should provide detailed research information and verification information. This guideline should be used under the premise of complying with relevant regulations.

Scope of Application

This guideline applies to devices that obtain the shape of the corneal surface through a non-contact method, utilizing the working principle of optical imaging/measurement. According to the 2017 edition of the Classification Catalog of Medical Devices, this type of device is managed as a Class II medical device, covering applicable products with classification code 16-04-12. Other medical devices that utilize optical principles to obtain the shape of the corneal surface can refer to the applicable part of this guideline.

Key points for registration review

The division of registration unit should focus on the consideration of the working principle, the difference in the scope of application, different imaging/measuring principle (optical path design) and the scope of application should be divided into different registration units. For example: (1) A device that measures the shape of the corneal surface by analyzing the Placido ring image reflected from the corneal surface and a corneal topographer that measures the shape of the corneal surface by analyzing multiple optical sections of the corneal surface should be classified as different registration units. (2) A corneal topography device that acquires corneal surface shape and multiple other ophthalmic biological parameters (resulting from differences in optical path design) shall be classified as a different unit of registration from a device that acquires only corneal surface shape.

Product risk management information

The main risks of measurement devices include energy hazards, biological hazards, environmental hazards, hazards related to use, functional failure and aging-related hazards, etc., should be in accordance with the requirements of GB/T 42062, "Risk Management of Medical Devices for Medical Devices," describes the safety characteristics of the product in the design, raw materials, production and processing, packaging, transportation, storage, use and other aspects of the life cycle, from the Biological hazards, environmental hazards, hazards related to the use of hazards, due to functional failure, aging and improper storage of hazards caused by the product to carry out a comprehensive risk analysis, and details of the risk control measures taken and the verification results, if necessary, need to cite the test and evaluation report. For each of the possible hazards involved in the identification and assessment, the implementation of risk control to reduce the risk, the acceptability of the residual risk assessment, the product benefit compared to the overall evaluation, and the formation of the product before the market for the comprehensive review of its risk management activities to form a risk management report, the report is intended to explain and commitment to risk management program has been properly implemented, and after verification of the comprehensive residual risk is judged to be acceptable.

Basic principles of safety and performance

The applicability of the declared product to the requirements in the Basic Principles of Safety and Performance of Medical Devices (Annex 1) should be clarified. For inapplicable requirements, the reasons for inapplicability should be stated item by item. For the applicable requirements, should be itemized to meet the requirements of the method used, as well as to prove its compliance with the documents. Documentation to prove compliance with the requirements, if included in the declaration of product registration information, should indicate its specific location in the declaration. For documents not included in the declaration of product registration information, should indicate the name of the evidence document and its quality management system documents in the number.

Product technical requirements

Product performance indicators should be able to reflect the scope of application of the declared product requirements and test methods for each measurement parameter. In addition to the requirements of the industry standard YY / T 0787 should be in line with the requirements of the light source should also specify the performance of the light source, measuring head displacement adjustment range and measurement performance. Light source performance requirements include at least the wavelength, tolerance and radiant power of all light sources of the device (imaging light source, illumination light source, solid view light source, etc.), measurement performance requirements include at least the measurement range, tolerance, repeatability, etc..

Software functions and network security can be prepared according to the actual situation of the product.

Should also be declared according to the working principle of the product to clarify the actual characteristics of the product, such as the number of rings of Placido's disk and the number of measurement points or the number of optical cross-section picture and measurement angle.

Electrical safety should meet the requirements of GB 9706.1; electromagnetic compatibility should meet the requirements of YY9706.102; laser light source should also meet the requirements of GB 7247.1.

Inspection report

The applicant for registration shall provide a product inspection report, the product inspection report shall comply with the requirements of the drug supervision and management department of the State Council, which can be the self-inspection report of the applicant for registration of the medical device, or the inspection report issued by a medical device inspection organization entrusted with the qualification of medical device inspection.

Inspection report to provide software version of the interface photo or list the software version information, with a user interface software to reflect the software release version, the full version of the software, no user interface software to reflect the full version of the software.

Inspection of product typicality: the same registered unit to select the most complex structure, the most functional, the highest technical indicators of the model performance and electrical safety testing. If the detection of a model can not cover all the performance functions of other models, the other models can not cover the part of the difference in detection. Differences in optical path design, light source, differences in function/application range, etc. should be analyzed at least.

Clinical evaluation requirements

If the corneal topographer is different from the products described in the Catalog, clinical evaluation should be conducted in accordance with other evaluation paths in the Technical Guidelines for Clinical Evaluation of Medical Devices. Products or working principles or functions that are not included in the "Catalog of Medical Devices Exempted from Clinical Evaluation", such as obtaining the biological parameters of the anterior eye segment. The applicant for registration shall submit clinical evaluation information based on the structural composition, performance parameters and intended use of the declared product, etc., with reference to the "Technical Guidelines for Clinical Evaluation of Medical Devices", "Technical Guidelines for Demonstrating the Equivalence of Medical Devices" and other relevant requirements.