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

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.

Silicone rubber exhibits outstanding mechanical properties, excellent transparency, and superior biocompatibility. It is easy to mill and extrude and resistant to high temperatures. It is designed for medical devices intended for implantation exceeding 30 days (such as finger joint prostheses and breast implants).

Technical documentation for medical device raw materials (excluding in vitro diagnostic reagents) generally includes descriptions of the raw material composition, physicochemical property studies, biological evaluation data, toxicological risk analysis, and process studies. For silicone rubber, testing can be conducted with reference to the following indicators.

(1) Physicochemical Properties

Observe the appearance of silicone rubber, loss on drying, determination of trace elements (lead, cadmium, arsenic, chromium, iron, etc.), and requirements for leachables (solution appearance, residue on evaporation, acidity/alkalinity, catalyst residues, reducing substances, UV absorption, heavy metals).

(2) Identification

Testing shall be conducted in accordance with the pharmacopoeia infrared spectrophotometry method to obtain the infrared spectrum of the silicone rubber.

(3) Biocompatibility

As for raw materials for medical devices, corresponding biological testing may be performed on the final products in accordance with the requirements of GB/T 16886.1. For example, when used as a breast implant intended for persistent contact (>30 days) with human tissue, the following endpoints shall be considered: cytotoxicity, sensitization, irritation or intracutaneous reactivity, material-mediated pyrogenicity, acute systemic toxicity, subacute toxicity, subchronic toxicity, chronic toxicity, implantation effects, genotoxicity, and carcinogenicity.

(4) Sterilization Validation

Medical devices and components manufactured from silicone rubber can be sterilized. The available sterilization methods include steam, ethylene oxide, and radiation sterilization. However, repeated sterilization may compromise the material’s mechanical strength and physicochemical properties. Therefore, medical devices manufacturers shall conduct studies on different sterilization methods and frequencies to verify that the silicone rubber continues to meet requirements in terms of performance, structural composition, and biological safety after the specified sterilization process and number of cycles (if applicable).

(5) Shelf Life and Packaging/Transportation

The registered product shall verify the validity period and packaging and transportation in accordance with the requirements for raw materials of medical devices. Relevant testing may 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.

As of July 31, 2025, the National Medical Products Administration (NMPA) has successfully registered 7 silicone rubber raw material products. The summary is as follows:

No.	Owner Name	Master File Registration Item	Master File Registration Number	Registration/Update Date
29	Elkem Silicones USA Co., Ltd.	SILBIONE® BIOMEDICAL HCRA M500 Series Silicone Materials	M2021029-001	2025/7/31
94	Wynca Tinyo Silicones Co., Ltd. Co., Ltd.	Wynca Tinyo TYE771 Series Silicone Materials	M2022061-001	2022/10/31
116	Wynca Tinyo Silicones Co., Ltd. Co., Ltd.	Wynca Tinyo XHG-6920 Series Silicone Materials	M2022083-000	2022/10/31
296	Elkem Silicones USA Co., Ltd.	SILBIONE® BIOMEDICAL LSR M300 Series Silicone Materials	M2023156-000	2023/12/8
702	DDP Specialty Electronic Materials US 9, LLC	Implant-grade Silicone Rubber (<30 days)	M2024372-000	2024/12/9
752	DDP Specialty Electronic Materials US 9, LLC	Implant-grade Silicone Rubber (>29 days)	M2024422-000	2024/12/27
793	Shenzhen Momaclever Chemical Technology Co., Ltd.	Medical Silicone Rubber Film	M2025036-000	2025/2/11

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