P34HB (trade name: Machnoon-II), as an implantable PHA material of Zhuhai Maidefa Company, has successfully completed the filing of the master file of Class III medical device raw materials (record number: M2023047-000) at the Center for Medical Device Technical Evaluation (NMPA) of the Medical Products Administration on April 21, 2023 after more than two years of verification testing, which means that medical device manufacturers will no longer have to repeat the relevant biological verification of the material. It greatly saves the development time of device products; Medical-grade PHA will also achieve a safe, stable, and compliant supply; It has opened up a new application track for PHA innovative biomedical materials in China, and will further help the application of PHA in the global medical field.

At that time, when a medical device manufacturer applies for registration of a PHA medical device product, the company will issue a master file authorization letter to the registration applicant. When the regulatory agency reviews the medical device application materials, it can access the registered master file materials for related review according to the authorization letter.

About Zhuhai Maidefa:

Zhuhai Maidefa has developed a core patent system for the purification and large-scale preparation of medical PHA raw materials, which has successfully solved the problem of "stuck neck" of biomedical materials in China. At present, a variety of medical devices are being developed in depth, such as: medical beauty microspheres, interventional treatment microspheres, drug sustained-release microspheres, various regenerative membrane products and artificial blood vessels.

The company has completed the construction of a 1,000-ton production line in Zhanjiang, Guangdong, and can stably supply industrial-grade PHA materials for various high-end industrial and consumer goods applications, while providing a solid supply guarantee for medical-grade PHA materials. In terms of innovation, the company has formed an independent independent patent system, published 2 articles (including 1 international journal article), applied for more than 50 core invention patents at home and abroad, and has been approved as a postdoctoral research workstation in Hengqin New District, Zhuhai City, a national high-tech enterprise, and a biosynthesis engineering technology research center in Guangdong Province.