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:
Research materials should include:
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 | firstname.lastname@example.org (978) 390-4453 www.chinameddevice.com