Polycarbonate (PC), as a biodegradable polymer material, has various application scenarios in the medical field. These include disposable ophthalmic surgical knives, ophthalmic trocars/cannulas, polymer materials and products for dentures, orthopedic core drill, auxiliary instruments for vertebroplasty, and ring-handle syringes. As a raw material for medical device products, PC can undergo Master File registration. This authorizes medical device registration applicants to reference it as part of their regulatory submission when applying for medical device registration.

PPDO (Poly-p-dioxanone) is a class of aliphatic poly(ether-ester) polymers renowned for their excellent mechanical properties, biocompatibility, and biodegradability. As early as the last century, it was approved by the U.S. FDA for use in manufacturing Class III medical devices. It serves as a key material for producing absorbable sutures, cosmetic lifting threads, ligation clips, abdominal meshes for hernia repair, and other implantable devices. PPDO, along with its copolymers, blends, and composite materials, is also being developed for applications in bone repair, vascular stents, tissue adhesives, drug sustained-release carriers, and aesthetic products such as "ELLANSé" and "SCULPTRA".

The Medical Device Master File is a form of technical documentation submitted by its owner to the medical device technical review authority. It is used to authorize medical device registration applicants to reference it as part of their registration submission materials when applying for medical device registration. The Medical Device Master File system facilitates the selection of raw materials and key components by medical device manufacturers and simplify the registration and application process. Simultaneously, the principle of voluntariness and confidentiality for the master file registration effectively protect the intellectual property rights of the master file owner.

The Medical Device Master File is a form of technical documentation submitted by its owner to the medical device technical review authority. It is used to authorize medical device registration applicants to reference it as part of their registration submission materials when applying for medical device registration. As a raw material for medical device products, recombinant collagen is eligible for master file registration.