Pacific Kangtai Completes Medical Device Master File Registration for Bioactive Glass 

In-house Bioactive Glass raw material reaches a new regulatory milestone in China

JINAN, China — Pacific Kangtai Scientific Instruments (Jinan) Co., Ltd. has completed the Medical Device Master File registration for its in-house Bioactive Glass raw material in China.

The master file is registered under:

Medical Device Master File Registration No.: M2026330-000

This registration represents another important regulatory milestone for Pacific Kangtai’s medical raw material portfolio and further strengthens the technical and regulatory documentation available to medical device manufacturers and R&D teams evaluating Bioactive Glass for product development in China.

Bioactive Glass is an important functional biomaterial that can be explored for a variety of medical device development directions, including bone repair materials, dental materials, implant coatings and composite biomaterial systems.

For medical device developers, the evaluation of a raw material involves not only material composition, particle size and functional properties, but also documentation, quality consistency and traceability throughout the product development and registration process.

The completion of the master file registration further enhances Pacific Kangtai’s ability to support customers in the development and regulatory evaluation of Bioactive Glass-based medical devices.

Pacific Kangtai continues to develop and improve its biomaterial portfolio, including Bioactive Glass, Hydroxyapatite and recombinant functional raw materials, while strengthening the associated quality and regulatory documentation systems.

For customers interested in evaluating Bioactive Glass for medical device applications, relevant product specifications, COA, technical documentation and project support can be provided according to specific development requirements.

Medical Device Master File Registration No.: M2026330-000

Pacific Kangtai Scientific Instruments (Jinan) Co., Ltd.