国内医疗器械注册申请材料清单 ：
1、医疗器械注册申请表
2、证明性文件
3、医疗器械有效基本要求清单
4、综述资料
5、研究资料
6、生产制造信息
7、临床评价资料
8、产品风险分析资料
9、产品技术要求
10、产品注册检验报告
11、产品说明书和zui小销售单元的标签样稿
12、 符合性声明
IVDEAR专注于为国内外各大企业提供：欧代、英代、CTDA注册、UKCA认证、WHO EUA、HSC欧盟通用名单（comment list清单）、欧盟ce认证（IVDD CE/IVDR CE MDR CE/MDD CE）、临床试验、适用性研究、变异毒株试验、TGA、自由销售证书fsc、英国MHRA、技术服务、SRN注册、加拿大CMDCAS、MDEL等认证咨询服务，专-业、迅速、助力合规如有需求，欢迎您来咨询!
IDVEAR公众号
.jpg "62500c9c1e414(1).jpg")
Tel：0755-33509057
Adress：Building 2, Building B, Building 103-110, Baoxin Science and Technology Park Factory Area, No. 9 Guangyuan Fifth Road, Fenghuang Street, Guangming District, Shenzhen City, Guangdong Province.
E-mail：hitolin@ivdear.com
IVDEAR can undertake the whole process of technical guidance and services such as prospective clinical, who Eul, variant virus research (Delta, Omicron ba.1, ba.2), IVDD CE, ivdr CE, Australian TGA, British CTDA, European HSC common list, European service, British service, etc.
If you have products that have been tested and certified or want to know more about them, please contact IVDEAR！
Popular keywords：UK authorised representative CTDA registration HSC EU common list Canada cmdcas certification Canadian del certification Australian TGA certification Registered in Hong Kong Medical device certification Variant strain test Who Eul application IVDD CE certification IVDR CE认证 EU authorized representative SRN registration Ukca certification
友 情 链 接：国瑞质量检验中心
Copyright © 艾维迪亚（深圳）医疗科技有限公司 All rights reserved