Haizhi Biotechnology participated in the final meeting for the "Guidelines for the Registration Review of Medical Gynecological Gels."

Haizhi Biological participated in the final meeting of the "Guidelines for the Registration Review of Medical Gynecological Gels".

To successfully complete the writing plan for the 2023 registration technical review guidelines for Class II medical devices by the National Medical Products Administration's Medical Device Technical Review Center, the research work on the "Guidelines for the Registration Review of Medical Gynecological Gels" was organized in June this year by the Shandong Provincial Food and Drug Review and Inspection Center. Relevant technical personnel from this center and the Jiangsu Provincial Drug Supervision Administration's Review Center were invited to conduct on-site research at our company. The participants visited the production site of medical gynecological gels, learned about the product structure, working principles, raw material control, manufacturing processes, quality control, etc., and discussed issues encountered during the guideline writing process. In October, our company, as a corporate representative, was invited to participate in the mid-term meeting of the "Guidelines for the Registration Review of Medical Gynecological Gels" project held by the Shandong Provincial Food and Drug Review and Inspection Center, where the initial draft of the guidelines was discussed, and opinions and suggestions were provided. On November 28, our company participated again in the final meeting to review the "Guidelines for the Registration Review of Medical Gynecological Gels."

Haizhi Biological is deeply involved in the entire process of writing the "Guidelines for the Registration Review of Medical Gynecological Gels," which reflects Haizhi Biological's rigor in product research and development applications and strict quality control in the production process, and has been recognized by regulatory authorities.

About Haizhi Biological: Jiangsu Haizhi Biological Pharmaceutical Co., Ltd. is located in Nanjing Jiangbei New District (referred to as: Haizhi Biological). It is a comprehensive high-tech enterprise integrating R&D, production, and sales. The company focuses on skin and mucosal injury repair, with a layout in transdermal drug delivery and skin and mucosal health care. Currently, the main business operations include the R&D, production, and sales of medical devices, cosmetics, and other series of products. The company has established a complete range of Class II medical devices and functional skincare products and is preparing for the industrialization of Class III medical devices and drug-device combinations. Haizhi Biological has successively obtained a series of independent research and development achievements, applied for 27 patents, registered 76 trademarks, and registered more than 20 Class II medical device products. Since 2018, it has been recognized as a private technology enterprise in Jiangsu Province, a national/Jiangsu Province/Nanjing City high-tech enterprise, a technology-based small and medium-sized enterprise, and a "specialized, refined, distinctive, and innovative" small and medium-sized enterprise in Nanjing.