Two Group Standards Approved
The Standards Working Committee of the Chinese Society for Biomaterials, in accordance with the "Chinese Society for Biomaterials Group Standards Management Measures (Trial)," conducted project approval reviews for two group standards co-drafted by Medgen:
- "Evaluation Methods for In Vivo Degradation and Collagen Regeneration Performance of Degradable Microsphere or Microparticle Facial Soft Tissue Implants"
- "Injectable Hydroxyapatite Microsphere Gel"
Following the project approval review and public notice procedures, both group standards were approved for formal project initiation.
Expert Review
During the review meeting, the expert panel received detailed briefings on the standard compilation process and unanimously agreed that both standards co-drafted by Medgen were well-supported, with rigorous, scientific, and applicable content in all sections. The standards comply with the requirements of GB/T 1.1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules for Standardization Documents" and the Chinese Society for Biomaterials group standards management regulations.
Significance of the Standards
The "Injectable Hydroxyapatite Microsphere Gel" standard aims to regulate product quality and safety in the medical aesthetics injection field for products using hydroxyapatite microspheres as an implant or composite implant component, improving product reliability and consistency to safeguard consumer health and safety. Currently, no standards exist domestically or internationally for injectable hydroxyapatite microsphere gel products used in medical aesthetics — this group standard is the first of its kind. The standard also provides guidance for manufacturers and regulators, promoting the healthy development of the medical aesthetics injection industry.
The "Evaluation Methods for In Vivo Degradation and Collagen Regeneration Performance of Degradable Microsphere or Microparticle Facial Soft Tissue Implants" standard applies to inorganic non-metallic materials, degradable synthetic polymers, and/or natural polymer-based facial soft tissue implants. It provides evaluation methods for studying the degradation and collagen regeneration performance of degradable microsphere or microparticle facial soft tissue implant products in animal studies.
Next Steps
The successful passage of the project approval review has effectively encouraged Medgen's technological and management innovation, enhancing the company's market competitiveness and brand influence. Moving forward, Medgen will organize relevant personnel to begin the outline compilation phase, focusing on industry-leading technologies to draft forward-looking, standardized, and instructive group standards. The company aims to establish higher quality benchmarks for the application of hydroxyapatite products in facial augmentation, contributing to the industry's high-quality development.