Application of hyaluronic acid in medical devices

Sodium hyaluronate is a commonly used polymer material, which has the functions of lubrication, moisturizing, filling and preventing tissue adhesion, so it is widely used in medical dressings. In the field of medical devices, sodium hyaluronate has a variety of common names, although it is not clearly specified, but the industry is generally called sodium hyaluronate.

According to the different degree of risk, medical sodium hyaluronate gel, sodium hyaluronate film (anti-adhesion) and medical sodium hyaluronate gel (ophthalmic viscoelastic agent) belong to the third class of medical devices, which need to be submitted to the State Drug Administration for review and obtain a medical device registration certificate. General medical sodium hyaluronate dressings, lubricants and repair sheets belong to the second class of medical devices, which can be reviewed by the provincial drug administration. Class iii medical devices registration number in the form of: "China machinery note * * * * *", the second category of medical device registration number in the form of: "black machinery note * * * * *", "shandong machinery note * * * * *".

In the registration process of medical devices, there are no specific qualification requirements for the sodium hyaluronate raw materials used. Therefore, sodium hyaluronate raw materials do not need to have drug certificates or excipients certificates when registering medical devices.

However, according to the production management requirements of medical devices themselves, the quality management of sodium hyaluronate raw materials is a part of the production management of medical devices. According to the classification and risk division of medical devices, the quality management of sodium hyaluronate raw materials may also have different grades. This is also why many medical device manufacturers prefer sodium hyaluronate (sodium hyaluronate) that has a drug certificate or is produced in accordance with the excipient registration requirements.

AVT crosslinking sodium hyaluronate strictly control the crosslinking process, BDDE residue is less than 200 times the line standard, suitable for medical and American injection fillers, joint injection and other products, welcome to contact!