Pacific Kangtai Completes Medical Device Master File Registration for Hydroxyapatite 

Pacific Kangtai Scientific Instruments (Jinan) Co., Ltd. has completed the Medical Device Master File registration for its Hydroxyapatite (HAp) raw material in China.

The Hydroxyapatite master file is registered under:

Medical Device Master File Registration No.: M2026075-000

This milestone further strengthens the regulatory documentation available for customers evaluating Hydroxyapatite raw materials for medical device development and registration projects in China.

For medical device manufacturers and biomaterial R&D teams, raw material evaluation involves more than particle size, morphology and material properties. Regulatory documentation, quality consistency and traceability also become increasingly important as a project progresses from early-stage research toward product development and registration.

Hydroxyapatite is an important biomaterial platform that can be explored across a range of medical device development directions, including:

• Bone repair materials
• Dental biomaterials
• Medical coatings
• Composite biomaterial systems
• Porous Hydroxyapatite microsphere platforms

Pacific Kangtai continues to expand its Hydroxyapatite material portfolio with different particle sizes and morphologies to support different technical and formulation requirements.

For customers developing HAp-based medical devices in China, our team can provide relevant technical documentation, product specifications, COA and regulatory support information according to project requirements.

Medical Device Master File Registration No.: M2026075-000

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