Recently, the T/GDMDMA 0035-2024 "Sodium Chondroitin Sulfate for Medical Devices" group standard was issued by the Guangdong Medical Devices Management Academy(GDMDMA) in accordance with the "Standard Development Procedure Document_GDMDMA" published. Shandong Topscience Biotech was participated in drafting and formulation. Implementation date is November 25, 2024.

The standard document specifies the technical requirements and inspection methods for sodium chondroitin sulfate for medical devices, and is applicable to sodium chondroitin sulfate materials extracted from cartilage of terrestrial and marine origin.

As the first manufacturer of sodium chondroitin sulfate for medical devices in China, Topscience Biotech has successively obtained medical device master file registration numbers. The master file registration of sodium chondroitin sulfate as a raw material for medical devices (registration number: M2024112-000), the master file registration of sodium chondroitin sulfate for medical cosmetology (registration number: M2024310-000), and the master file registration of sodium chondroitin sulfate for bladder mucosal repair (registration number: M2024308-000). In addition, Topscience Biotech has also completed safety tests, biological evaluations and virus inactivation verification.

The release of the standard T/GDMDMA 0035-2024 "Sodium Chondroitin Sulfate for Medical Devices" marks a further breakthrough of sodium chondroitin sulfate for medical devices in China. This standard offers more reliable security for research and innovation in Class II and Class III medical devices, driving the industry's continuous advancement and high-quality development. Topscience Biotech is excited to collaborate with industry partners to develop new products and achieve groundbreaking innovations in the pharmaceutical field.