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    四川医疗器械生物材料和制品检验中心成立于2003年,是由四川大学设立,国家生物医学材料工程技术研究中心组建,从事医疗器械检验检测评价专业技术服务的第三方独立法人实体。

检验资质及范围

 “中心”是经中国国家认证认可监督管理委员会资质认定(计量认证CMA)、中国合格评定国家认可委员会认可(CNAS L3940)、国家食品药品监督管理总局医疗器械检测机构资格认可(CFDA)的医疗器械生物材料检验评价机构,可向国内外出具具有法定效力的中英文检测评价报告。“中心”现有授权能力127个产品,180个参数。主要从事医疗器械的注册检验、临床前生物安全性评价、动物有效性试验研究、以及标准和方法的建立研究等。检测材料类型包括金属、陶瓷、聚合物类的口腔材料、矫形整形外科材料、软硬组织修复材料、可诱导组织再生医学材料如软骨、心血管支架、神经、角膜、皮肤、肌腱、3D生物打印医疗器械产品等。

专业团队

 “中心”拥有国际水准的专家顾问团队、富有丰富经验的专业技术团队和高素质的技术管理团队,也是全国医疗器械生物学评价标准化技术委员会、全国外科植入物和矫形器械标准化技术委员会、组织工程医疗器械产品分技术委员会和全国口腔材料和器械设备标准化技术委员会的委员单位。具硕士学历及以上检验人员占检验人员总数65%以上。

发展目标 & 愿景

 “中心”秉持“公正、科学、求是、高效”的质量方针,致力于打造临床前的一站式医疗器械生物材料检测评价平台,为客户的新技术、创新产品节约成本、缩短上市时间。预计2019年,“中心”将主体搬迁至成都高新区国际生物城,成为拥有13000余平米专用实验室,包括6000余平米的SPF级标准动物实验室和大动物有效性实验室的先进机构,助力生物医药产业发展,造福人类健康。

 

Founded in 2003, Sichuan Testing Center for Biomaterials and Medical Devices engages in professional technical services of medical instrument testing and evaluation as third party independent legal entity. It is invested by Sichuan University and is formed by National Engineering Research Center for Biomaterials.

Certificates and Testing Scope

The Center is a medical instrument testing and evaluation institution. It has been accredited by Certification and Accreditation Administration of the People’s Republic of China(Metrology Accreditation Certificate, CMA), accredited by China National Accreditation Service for Conformity Assessment(CNAS L3940)and accredited by China Food and Drug Administration(CFDA).It is able to issue legally effective testing and evaluation reports in both Chinese and English. The Center has 127 licensed products and 180 parameters. It mainly engages in medical instrument registration test, preclinical biosafety evaluation, experimental study on animal effectiveness, as well as establishment of standards and methods. The types of testing materials include metals, ceramics, polymer dental materials, orthopedic surgical materials, soft and hard tissue repair materials, inducible tissue regeneration medical materials(such as cartilage, cardiovascular stent, nerve, tendon, cornea, skin and 3D bio printing products)and so on.

Professional Team

The Center owns an international standard consultant team, experienced professional technical team and high-quality technical management team. The Center is also member of SAC/TC248, SAC/TC110/SC3 and SAC/TC99. More than 65% of inspectors are master’s degrees or above.

Goals and Vision

Based on the policy of “Fair, Scientific, Precise, Efficient”, the Center commits to build preclinical one-stop medical instrument biomaterials testing and evaluation platform so that it can save cost and shorten time to market for clients’ new technologies or innovative products. It is expected that in 2019, the Center will be relocated to Chengdu Hi-Tech Industrial Development Zone Tianfu International Biotown and become an advanced institution which owns more than 13000 square meters professional laboratory including more than 6000 square meters SPF animal laboratory and large animals’ effectiveness laboratory. Boost the development of biopharmaceutical industry, benefit human health.



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