China Registers First PHA Microsphere Medical Filing Empowering Over 3 Major Application Areas

Zhuhai Medpha Bioscience has officially completed registration of its medical-grade PHA microsphere material under China’s CMDE master file system (Filing No. M2025155-000), marking a breakthrough for domestic bio-based medical materials. This is the first time a PHA microsphere has been registered through the national master file system for medical devices.

The master file mechanism helps standardize key raw materials, enabling downstream Class III device manufacturers to reduce regulatory burdens and accelerate product approval. With Medpha’s material now documented, companies can link directly to the file using an authorization letter, eliminating redundant data submissions and shortening review timelines.

PHA (Polyhydroxyalkanoates) is gaining attention as a next-gen biodegradable and biocompatible material. Derived from microbial synthesis, it breaks down safely inside the body, supports ATP production, and leaves no toxic residues—making it ideal for implantable devices. Potential uses include aesthetic soft tissue repair, tumor embolization, regenerative scaffolds, and long-acting drug delivery.

Medpha has built a full-chain capability in PHA, from high-purity medical-grade extraction to scalable production and clinical application. The company holds over 50 patents, and its industrial-grade PHA facility in Zhanjiang ensures secure supply. Through partnerships with academic research centers, Medpha is advancing next-gen biomaterials like regenerative membranes and artificial vessels.

With this filing, Medpha provides the industry with an “off-the-shelf” high-standard biomaterial, paving the way for domestic innovation in high-value medical devices. The move not only breaks foreign monopolies but also strengthens China’s position in the global biomaterial market.