CFDA Update: Optical Coherence Tomography (OCT) Technical Review Guideline Draft

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CFDA Update: Optical Coherence Tomography (OCT) Technical Review Guideline Draft

On June 9th, CFDA issued a technical review guideline on Optical Coherence Tomography (OTC) for comments. 

The guideline is intended to guide the applicant’s preparation and writing of registration documents for Optical Coherence Tomography (OCT) ophthalmology devices. It provided a reference for the technical review department to review the registration report as well.

Currently the mainstream ophthalmology devices OCT is based on frequency domain principle. So his guideline is mainly for the OCT with the frequency domain coherent principle. For OCT with time domain coherence principle or any other principle, this guideline serves as a reference.

1.     Working Principle (frequency domain OCT as the example)

The optical coherence tomography is used to measure and calculate the backscattered light from the ocular tissue by optical interference of near-infrared light, thereby generating an ocular tissue tomographic image. Optical coherence tomography uses the difference between different tissue’ ability of light reflection, absorption and scattering to create the imaging and achieve the purpose of clearly distinguishing the tissue structure.

2.     Registration Unit Basis

Registration unit should be consistent with the relevant laws and regulations or guiding principles. Under normal circumstances, different model can be used as a registration unit if the only difference between them is the number of functions. OCTs with different intended use could not be used as a registration unit. OCTs with different working principles could not be used as a registration unit. For the same registration unit, the applicant should use typical model that has most complex structure, the highest indicator and the richest functions to do the test.

3.     Medical Device Safety and efficacy Requirements List

Applicants could fill out the method to use to comply and provide the documents with objective evidence for compliance according to the specific situation.

If you need the English version of this list, contact us at . China Med Device, LLC, specializing in providing turn-key solution for medtech companies entry into China, brings you up to date information on CFDA.

On June 9th, CFDA issued a technical review guideline on Optical Coherence Tomography (OTC)for comments.

The guideline is intended to guide the applicant’s preparation and writing of registration documents for Optical Coherence Tomography (OCT) ophthalmology devices. It provided a reference for the technical review department to review the registration report as well.

Currently the mainstream ophthalmology devices OCT is based on frequency domain principle. So his guideline is mainly for the OCT with the frequency domain coherent principle. For OCT with time domain coherence principle or any other principle, this guideline serves as a reference.

 

1. Working Principle (frequency domain OCT as the example)

The optical coherence tomography is used to measure and calculate the backscattered light from the ocular tissue by optical interference of near-infrared light, thereby generating an ocular tissue tomographic image. Optical coherence tomography uses the difference between different tissue’ ability of light reflection, absorption and scattering to create the imaging and achieve the purpose of clearly distinguishing the tissue structure.

2. Registration Unit Basis

Registration unit should be consistent with the relevant laws and regulations or guiding principles. Under normal circumstances, different model can be used as a registration unit if the only difference between them is the number of functions. OCTs with different intended use could not be used as a registration unit. OCTs with different working principles could not be used as a registration unit. For the same registration unit, the applicant should use typical model that has most complex structure, the highest indicator and the richest functions to do the test.

3. Medical Device Safety and efficacy Requirements List

Applicants could fill out the method to use to comply and provide the documents with objective evidence for compliance according to the specific situation.

If you need the English version of this list, contact us at . China Med Device, LLC, specializing in providing turn-key solution for medtech companies entry into China, brings you up to date information on CFDA.

4. Review Key Points

a. Product name

The product name consists of a core word and no more than 3 characteristic words. The core word of OCT is “Scanner”. The three characteristic words are “ophthalmology”, “optical coherence” and “tomography” .

b. Product Structure

The product structure can include optical host, power part, chin cradle part, front section adapter (optional), non-embedded software, etc. If the product must be used with the computer, regardless of whether the computer is part of the product composition, the computer’s brand and specification models should be limited, and should be consistent with the computer used in electromagnetic compatibility testing.

c. Intended Use and Contraindications

Ophthalmic OCT is used for tomographic imaging of the anterior segment and / or posterior segmental tissue, operated by trained ophthalmologists and technicians for use in medical institutions. The anterior segment OCT can be used for tomography and measurement of cornea and corners, which can be achieved through the anterior segment adapter. The posterior segmental OCT is primarily used for retinal tomography, and if there is any other analysis (eg, glaucoma analysis), imaging (eg, fundus imaging, angiography) or measurement (eg, macular thickness measurement), they can be described in the intended use with the appropriate technical information and clinical evaluation of information support.

Product contraindication is for patients who received photodynamic therapy in 48h.

Please be careful with following patients: high-risk groups of light radiation hazards, aphakia eyes, infants, or patients that are not sensitive to lights because of ocular fundus disease.

d. Summarized Data

1) Describe the main functions of the product, the function of each component and the characteristics of the product. The differences from the characteristics of similar products is the key point of technical review. In addition, the improvements. The meaning of improvements and the technical problems or clinical problems that have been solved should be described in the development background.

2) The information of referred congeneric products (Launched in China and abroad) or predecessor should be provided. Applicants should explain the research background and purpose of registration products. For congeneric products, the reason for choosing it as a research reference should be explained. Please list the similarities and differences between the registration product and referred product in terms of working principle, structure composition, performance index and scope of application.

e. Research Materials

1) Product performance research

Please provide the product performance research data and product technical requirements of research and preparation instructions, including functional, safety indicators and the basis of other indicators related to quality control.

2) Biocompatibility evaluation studies

Applicants should do the biocompatibility evaluation on the materials that will contact patients. There are points that need special attention:

· Biocompatibility evaluation should be done on the material in the finished product instead of the raw material

· For the biological test report in the research data, applicants could provide a domestic inspection report or an overseas inspection report. The test report shall include the sample preparation method, the test method and the test result.

· The biological test report should include the product name and model

3) Sterilization / disinfection technology research

If the product composition contains the accessory that needs disinfection, applicants should provide related research materials.

4) Product validity period studies

In general, the validity period of the OCT depends on the loss and aging of the components. Applicants should carry out the aging / fatigue test on the parts that cannot be replaced in the equipment, calculate the product validity period and provide the corresponding research materials.

5) Software research

Applicants should provide the appropriate software research materials in accordance with the requirements of the “Guidelines for the Technical Review of Medical Device Software Registration”.

6) Light radiation safety research materials

The product containing the light source shall provide information on the safety of light radiation. For ophthalmic OCT, the applicant may provide ISO15004-2 “ophthalmic instruments – basic requirements and test methods – Part 2: light hazard protection” test report

7) Environmental testing

Transportation, storage and usage environment will affect the performance of optical products, OCT should provide environmental testing research data.

f. Clinical Evaluation Data

Ophthalmology OCT is not included in the clinical trial exemption list. Applicants can do the analysis and evaluation based on the data from congeneric products’ clinical trial or clinical usage.

Applicants need to do the clinical trials in qualified clinical trial institutions if they cannot provide documents of clinical evaluation report.

If you want to get more detail information about CER/clinical trial, please contact us at

g. Risk Analysis

The risks associated with OCT include energy hazards, biological hazards, environmental hazards, hazards associated with operational use, hazards to software, ergonomic hazards, functional failures, hazards associated with maintenance and aging.

h. Product Technical Requirements

1) The tomography performance includes: the depth of scan, the width of scan, the horizontal resolution and longitudinal resolution of the scan in tissue, scan rate, minimum pupil diameter, etc.

2) Measurement performance requirements include measurement range, measurement accuracy and measurement repeatability.

3) The performance requirements of the light source include the wavelength and power of all the light sources.

4) The function of the software mainly includes software analysis and calculation function, data management function, scanning mode, etc.

5) Electrical safety requirements include GB9706.1

6) Electromagnetic compatibility should meet the requirements of YY0505.

7) Environmental testing should be carried out in accordance with GB / T14710

8) Other attributes and functions claimed by the applicant.

i. Registration Testing Report

1) The specifications and structure in the audit report are consistent with the application form. The terms of the inspection report shall be consistent with the technical requirements of the product.

2) For GB9706.1-2007, if it doesn’t’ complete the whole test, applicants should provide testing reports and qualification documents from foreign test institution. The standard version of overseas testing should be consistent with the domestic version.

3) The test model should be typical, and all models should be tested for electromagnetic compatibility and with the full performance test report associated.

4) In the electromagnetic compatibility report, the basic product information (voltage, frequency), coordinate equipment, classification and the relevant content should be consistent with the instructions.

5) In the electromagnetic compatibility report, the product type is generally a desktop device. If the product composition contains a table, it should do the testing based on landing equipment.

6) If the product is classified into Class B in the instruction book, harmonic distortion, voltage fluctuation and flicker in electromagnetic compatibility should be applied and tested.

j. Instructions and Labels

Applicants should pay attention to whether the instructions and labels meet the requirements of the 6 orders, GB9706.1 and YY0505. Technical parameters, classification and other products should be consistent with technical requirements, testing reports.