A new addition has been made to the HaiZhi Biotech product line.

HaiZhi Bio's product line has a new addition.

Recently, Jiangsu HaiZhi Biopharmaceutical Co., Ltd. (referred to as HaiZhi Bio) received a notification from the Jiangsu Provincial Drug Administration that the administrative approval for medical sodium hyaluronate dressings and medical sodium hyaluronate gels has been granted. The company has obtained two Class II medical device certificates, adding new products to its medical beauty product line.

On November 14, 2022, the National Medical Products Administration issued a notice regarding the management categories of medical sodium hyaluronate products (2022 No. 103) and related interpretations, which took effect immediately.

According to the new regulations, medical sodium hyaluronate products are mainly divided into two categories: "managed as drugs" and "managed as medical devices," based on different intended uses (indications), working principles, etc. Among them, those managed as medical devices must be classified as at least Class II.

It is clearly stated: "When used as a medical dressing, if the product can be partially or fully absorbed by the human body, or is used for chronic wounds, it is managed as a Class III medical device; if the product cannot be absorbed by the human body and is used for non-chronic wounds, it is managed as a Class II medical device." This means that Class II medical devices officially become the minimum compliance threshold for medical sodium hyaluronate products.

After the announcement was made, HaiZhi Bio studied the laws and regulations carefully, actively prepared relevant materials, overcame difficulties such as manpower shortages caused by the COVID-19 pandemic, and submitted a registration application for Class II medical devices of the sodium hyaluronate series products to the Jiangsu Provincial Drug Administration.

On December 29, 2022, just a month and a half after the announcement, the Jiangsu Provincial Drug Administration accepted HaiZhi Bio's registration application. In March 2023, the Provincial Drug Administration conducted an on-site inspection of the company's registration quality management system and passed it smoothly. In June 2023, HaiZhi Bio obtained the registration certificate for the medical sodium hyaluronate series products!

From the acceptance of the materials to obtaining the certificate, it took 5 months! Such high efficiency is attributed to the close cooperation of HaiZhi Bio's R&D and production teams, efficient operation, and strict quality control!

It is reported that HaiZhi Bio will soon have three more Class II medical device certificates approved. At that time, the Class II medical device product line for medical beauty will take shape and lay a solid foundation for HaiZhi Bio's entry into the research and marketization of Class III medical device products.

About HaiZhi Bio

Jiangsu HaiZhi Biopharmaceutical Co., Ltd. is located in Nanjing Jiangbei New District (referred to as HaiZhi Bio). It is a comprehensive high-tech enterprise integrating R&D, production, and sales, focusing on the research and development and industrialization of topical transdermal drug delivery formulations. HaiZhi Bio has successively obtained a series of independent R&D achievements, applied for 27 patents, authorized 21, obtained 1 authorized copyright, and registered 76 trademarks. 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.