Cross-linked polyisobutylene intraocular lenses enter the National Medical Products Administration’s special review procedure for innnovative medical devices

On May 21, the official NMPA website announced that cross-linked polyisobutylene intraocular lenses declared by Xi’an Eyedeal Medical Technology Co., Ltd. (formerly Xi’an Pillarbio technology Co., Ltd.) was approved for consideration by the medical device technology approval center under a special review for innovative medical devices.

The cross-linked polyisobutylene material independently developed and produced by the company is the world’s first application in intraocular lenses. The main features of the product are no calcification and no glare, which can meet the needs of large optical surfaces and small surgical incisions. Implantation, quick recovery, small postoperative astigmatism, and other performance indicators are superior to mainstream products.

The special examination procedure for innovative medical devices has been implemented since March 1, 2014. It applies to applicants who, through innovation, legally own the patent rights of a product’s core technology. The main working principle or mechanism of the product is the first in China. The technology leads on a global level. It is reported that this program has played a positive role in promoting R&D and innovation in medical devices, the promotion and application of new technologies, and high-quality industrial development, which will effectively shorten the product registration cycle and speed up the launch of products.