Home 主页
Services List 服务目录
Registration Service 注册服务
Clinical Evaluation Study 临床研究
Laboratory Testing 实验室测试
UDI Service 产品唯一代码服务
In-house Report 内部报告
US Agent 美代
EC Authorised Representative 欧代
Database 资料库
European Union 欧盟
Canada 加拿大
United States 美国
Austrilia 澳大利亚
General & Other 综合及其他
DownLoad 下载
Legislation 法规
Guidance 指引文件
Test Methods 测试方法
Contact Us 联系我们
Download
Legislation 法规
Guidance 指引文件
Test Methods 测试方法
Home
>
Download
>
•
Regulation_(JP)_MD&IVDR_Ordinance on Standards for Manufacturing Control and Quality Control
Download
•
Regulation_(AU)_MD&IVDR_Therapeutic Goods (Medical Devices) Regulations 2002
Download
•
Regulation_(BR)_MD&IVDR_RDC 16/2013_Quality System Regulation
Download
•
Regulation_(CA)_Medical Device_SOR-98-282_Quality System Regulation
Download
•
Regulation_(USA)_Medical Device_21 CFR Part 820 _FDA Quality System Regulation
Download
•
Regulation_(EU)_IVDR_ Medical Devices Regulation 2017/746
Download
•
Regulation_(EU)_MDR_ Medical Devices Regulation 2017/745
Download
•
Regulation_(UK)_Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)
Download
•
Regulation_(EU)_2016/425(PPE)_Personal Protective Equipment
Download
1
Copyright @ BUREAU MEDICAL COMPLIANCE SERVICES