CFDA Issues New Guideline for OCT Ophthalmology Devices

Grace Fu Palma, founder and CEO of Boston-based China Med Device, LLC, a firm specializing in commercialization and funding for medtech companies entering China, considers CFDA’s new draft guideline for registration of optical coherence tomography devices used in ophthalmology.

The CFDA issued a draft guideline June 9 on the preparation of registration documents for Optical Coherence Tomography (OTC) ophthalmology devices. The draft, which mainly focuses on devices using optical frequency domain reflectometry, can also serve as a reference for registering OCT devices based on other principles.

This is a must-follow guideline if you register OCT ophthalmology devices with CFDA. It details what the CFDA reviewer will be looking for in the review process, including:

• Product name;
• Product structure, such as optical host, power part, non-embedded software, etc. If a computer is used, limit the brand and specs to equipment covered by the CFDA’s standard for electromagnetic compatibility (EMC) of medical devices;
• Intended use and contraindications;
• Product summary, including the main functions, the function of each component and the characteristics. The differences from the characteristics of similar products is the key point of technical review.
• Predicate devices and associated information.

Research materials should include:

• Product performance research, such as functional, safety indicators and the basis of other indicators related to quality control.
• Biocompatibility evaluation studies. Materials tested should be finished goods that contact patients. The test report could be a domestic or an overseas inspection report.
• Sterilization / disinfection technology research.
• Product validity period studies.
• Software research. This needs to follow CFDA’s Guidelines for the Technical Review of Medical Device Software Registration.
• Light radiation safety research materials. These should follow ISO15004 -2, Ophthalmic Instruments - Basic Requirements and Test Methods - Part 2.
• Environmental testing: Transportation, storage and usage environment will affect the performance of optical products, OCT should provide environmental testing research data.

The risk analysis should consider energy hazards, biological hazards, environmental hazards, hazards associated with operational use, hazards to software, ergonomic hazards, functional failures, hazards associated with maintenance, and aging.

The product’s technical information should include the depth of scan, the width of scan, the horizontal resolution and longitudinal resolution of the scan in tissue, and the scan rate.

Whenever CFDA issues a guideline, devicemakers seeking CFDA registration of covered products should follow it like a bible to increase the chance of being approved. — Grace Fu Palma | gpalma@chinameddevice.com (978) 390-4453 www.chinameddevice.com