PMMA真皮填充物监管透明度与理化标准化：FDA/EU MDR/ANVISA三框架比较
Public transparency and physicochemical standardization in the regulation of PMMA dermal fillers: a comparative analysis of FDA, EU MDR, and ANVISA frameworks
作者：Evilasio Anisio Costa Filho、Suédina Maria de Lima Silva、Antonio Gilson Barbosa de Lima、Victhor Alexandre Vilarins Cardoso da Silva、Stela Candioto Melchior、Maria Glória Vicente、Marcus Vinicius Lia Fook、Suédina Maria de Lima Silva
单位：Graduate Program in Materials Science and Engineering, Northeast Biomaterials Evaluation and Development Laboratory (CERTBIO), Academic Unit of Materials Engineering, Federal University of Campina Grande, Campina Grande 58429-900, PB, Brazil.；Graduate Program in Materials Science and Engineering, Northeast Biomaterials Evaluation and Development Laboratory (CERTBIO), Academic Unit of Materials Engineering, Federal University of Campina Grande, Campina Grande 58429-900, PB, Brazil. Electronic address: albaniza.alves@certbio.ufcg.edu.br.；Graduate Program in Mechanical Engineering, Academic Unit of Mechanical Engineering, Federal University of Campina Grande, Campina Grande 58429-900, PB, Brazil.；National Health Surveillance Agency, General Management of Monitoring of Products Subject to Health Surveillance, Technovigilance Management, Brasília 71205-050, DF, Brazil.；Graduate Program in Materials Science and Engineering, Northeast Biomaterials Evaluation and Development Laboratory (CERTBIO), Academic Unit of Materials Engineering, Federal University of Campina Grande, Campina Grande 58429-900, PB, Brazil. Electronic address: suedina.maria@professor.ufcg.edu.br.
摘要
本文发表于《Regulatory Toxicology and Pharmacology》（2026年12月），系统比较FDA、欧盟MDR及巴西ANVISA三大监管体系对PMMA（聚甲基丙烯酸甲酯）真皮填充物的监管透明度与理化标准化要求。研究梳理各辖区在材料表征、临床试验证据及上市后监管方面的差异，揭示监管碎片化现状，为全球多地区申报提供合规参考。
AI 主编 · 推荐理由推荐理由
医美填充物企业若布局FDA/CE/Brazil多区域市场，本文的框架比较可直接指导注册策略制定，尤其在材料理化标准差异识别方面具有实操价值，建议注册与质量团队重点阅读。