Analysis of Master Files Registration for PPDO Raw Material - Regulatory News - Medical Devices

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".

As a raw material for medical device products, PPDO is eligible for the Master File registration. This process authorizes medical device registration applicants to reference the Master File as part of their regulation submission materials when applying for medical device registration. Technical documentation for medical device raw materials (excluding in vitro diagnostic reagents) typically includes descriptions of the raw material composition, physicochemical property studies, biological evaluation data, toxicological risk analysis, and process studies.

1) Process Flow

Describe the main production process based on the product manufacturing technology.

2) Referenced Standards

T/CSBME 054-2022 Poly-p-dioxanone (PPDO) Special Material for Absorbable Sutures

3) Physicochemical Properties Studies

Composition, appearance, inherent viscosity, moisture content, melt flow rate, glass transition temperature, melting point, residue on ignition, heavy metal content (as Pb), tin residue, monomer residue, solvent residue, degradability, etc.

4) Biocompatibility

As a raw material for medical devices, PPDO is often combined with various processing aids and dyes during manufacturing. Therefore, the biocompatibility of the raw material alone cannot represent that of the final medical device product. PPDO as a raw material can be preliminarily evaluated through three fundamental biological tests: in vitro cytotoxicity, skin irritation, and sensitization testing. Alternatively, biocompatibility testing can be conducted on the final product in accordance with the GB/T 16886 series standards. For example, when PPDO is used in an absorbable suture with an implantation contact duration of 24 hours to 30 days, the following biological endpoints should be considered: cytotoxicity, sensitization, irritation or intracutaneous reactivity, acute systemic toxicity, subacute toxicity, implantation effects, genotoxicity, etc.

5) Shelf Life and Packaging/Transportation

It is recommended to conduct shelf-life and packaging/transport validation per raw material requirements for medical devices. Relevant testing can be conducted with reference to: Guidance on Registration Documentation for Shelf Life of Passive Implantable Medical Devices, GB/T 19633 series standards, and YY/T 0681 series standards.

6) Others

If necessary, animal study reports or relevant literatures may be provided.

As of July 31, 2025, the National Medical Products Administration (NMPA) has successfully registered 5 PPDO raw material products. The summary is as follows:

No.	Owner Name	Master File Registration Item	Master File Registration Number	Registration/Update Date
247	Nanjing Polymer Medical Technology Co., Ltd.	Poly-p-dioxanone (PPDO) Suture Master File	M2023107-000	2023/9/18
342	Suzhou Seemine Red Maple Biotech Co., Ltd.	Poly-p-dioxanone (PPDO) Master File	M2024012-000	2024/1/23
525	Chengdu POLYMING Medical Materials Technology Co., Ltd.	Poly-p-dioxanone (PPDO) Pellet Master File Registration	M2024195-000	2024/6/8
909	Nanjing Puheyuan Medical Materials Co., Ltd.	Medical-grade Poly-p-dioxanone (PPDO)	M2025152-000	2025/5/7
931	Ningbo Baoting Biotechnology Co., Ltd.	Poly-p-dioxanone (PPDO)	M2025174-000	2025/5/29

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