Analysis for Registration of Plastic Surgery Implants
Plastic surgery implants are generally made of polytetrafluoroethylene (PTFE) and silicone rubber, which are used for filling the soft tissues on face or other positions. Plastic surgery implants are managed as Class III medical devices in China, such high-risk implant products normally need to conduct a clinical trial before obtaining its NMPA approval in China.
Major Overseas Manufacturers in China
At present, imported plastic surgery implants with NMPA approval in China are mainly from Implantech Associates, Inc. , Silimed-Indústria de Implantes Ltda and Surgical Technology Laboratories, Inc. . The total amount of overseas manufactures are still relatively small according to the data published by NMPA. The table below lists the majority of them.
| NO. | Manufacturer | Product name | Management Category |
| 1 | Implantech Associates, Inc. | Implantech Implants | Class III |
| 2 | Silimed-Indústria de Implantes Ltda | Facial Prosthesis | Class III |
| 3 | Surgical Technology Laboratories, Inc. | PureForm ePTFE Facial Implants/Surgiform Augmentation Material | Class III |
| 4 | Hans Biomed Corp. | Silicone Nasal Implants and Silicone Facial Implants | Class III |
Classification Information
| Classification code | Class I product category | Class II product category | Product Description | Intended use | Examples of product names | Management category |
| 13 Passive implantable devices | 09 Plastic and general surgical implants | 01 Plastic filling materials | Generally made of PTFE and silicone rubber. | Used for filling the soft tissues on face or other positions. | Silicone rubber surgical plastic implant, facial prosthesis, facial plastic filling material, facial plastic implant, silicone rubber subcutaneous soft tissue implant | III |
Division of Registration Units
- Facial implants with different materials should be classified as different registration units;
- Silicone rubbers with different constituent ratios and vulcanization degrees should be classified as different registration units;
- Products applied to different locations of a face can be registered as the same registration unit, but the scope of application should be clearly defined according to clinical evaluation data.
Requirements for Clinical Trials
Plastic surgery implants are not listed in the catalogue of medical devices exempted from clinical trials. Before approved by NMPA, a qualified clinical trial shall be conducted in advance. If the product has overseas clinical trial data in line with NMPA’s requirements, they can submit such data as a supplementary materials or replacement of the clinical trial in China. Given a large demand for plastic surgery and huge supply gap in Chinese market , IMD can help manufactures to make the best strategy for China registration. If you have any interests, please be free to contact us (info@inspirativemed.com) for more information.
