中英文对照—医疗器械经营企业设立流程

List of the legal representative or board of directors外资企业法定代表人（或董事会 人选）名单
Time Scale：15-20 working days
STEP3 Medical equipment business License （医疗器械经营许可证）
Pre-approval Registration of Enterprise Name
企业名称预核准 Administration Industry and Medical Commerce equipment 工商行政管理 business License 局
医疗器械经营企业许 Domicile certificate (The copy of Real estate ownership certification 可证
ID card of mandatary (Original and copy)经办人的身份证原件及其复印件 Corporate seal 企业公章 The approval of the national organization code 全国组织机构代码赋码通知单（新申请设立的外资企业法人，须持商务局的 批准文件，工商行政管理部门的名称预先核准通知书及复印件，经办人身份证 及复印件到组织机构代码管理中心服务大厅申办预赋码登记，取得全国组织机 构代码赋码通知单）
Department Required documents
Application for Pre-approval of Enterprise Name
Administration for Industry and Commerce
signed by all investors 投资人签署的《企业名称预先核准申请书》
Duplicate of Enterprise Code Certificate (Original and copy)组织机构统一代码证书副本原件及复印件 ID Card、passport or other identifications of legal representatives（法定代表人居民身份证、护照或其他证明身份的合法证 件原件及复印件） Approval of COC（Original and copy）商务部门批复设立证书原件及复 印件 The Certification of Registered address, management address and the address of production注册地址及生产、经 营地证明
Time Scale: 10-15working days
STEP 5 Corporate seal （公章）
Company Required documents
Business license企业营业执照副本原件、复印件
Authorized Seals company （制定刻章公 司）
Identification of the Legal Representative 企业法定代表人身份 证明 Letter Authorization signed by the legal Representative法人 授权委托书 Original and copy of the effective Identity Certificate of the mandatary 经办人有效身份证明原件及复印件
Time ຫໍສະໝຸດ Baiducale: About 30 working days
STEP 4 Business License（营业执照）
Department Precondition
Required Documents
Application for Foreign-invested Enterprise Establishment Registration signed by Legal representative法定代表人签署的《外商 投资企业设立登记申请书》 Articles of Association signed by all shareholders全体股东签署的公司 章程 Certification for the legal person qualification of shareholder or the copy identification of natural person 股东的主体资格证明或者 自然人身份证件复印件 certificate of approval of COC (duplicate1) 商务部门出具的《外商投 资企业批准证书》副本1 Certificate for Pre-approval Registration of Enterprise Name 企业名称 预先核准通知书 Letter Authorization signed by all share holders 全体股东签署的授权 委托书 Registry form of Enterprise Contacts企业联系人登记表
Time Scale: 7 working day
STEP 6 Tax Registration Certificate （税务登记证）
Department Required documents
Tax registration form（Entities taxpayer）税务登记表（单位纳税人）
Time Scale: 1 working day
STEP 7 Enterprise Code Certificate
Department Required documents
Sealed Application for Enterprise Code Certificate 加盖有单位公章的《 中华人民共和国组织机构代码申请表》
Approval by COC（商务主管部门批复） Medical Equipment Business License（医疗器械经营许可证） Business License(营业执照) Corporate seal（公章） Tax Registration Certificat（税务登记证）
Bureau of Quality and Technical Supervision 质量技术监督 局
business license (Original and copy)营业执照副本及其复印件
Identifications of legal representatives (Original and copy) 法定代表人 身份证件及其复印件
医疗器械经营企业设立流程
The Establishment Of Medical Equipment Business Enterprise
2014 . 08
License Requirement
Department
01
3
License Requirement
Company Name Pre-approval（企业名称预核准）
ID card, Diploma or Professional title certificate of quality managers (Original and copy) and their resume 质量管理人员的身份证、学历或者职 称证明原件和复印件及个人简历
Registered address and the location map and plans (specify area) of warehouse and the copy of Real estate ownership certification or other Certificate of rights to use the Real estate 注册地址（企业注册的经营地址）和仓库地址的地理位置图与平面图（注明面 积）以及房屋产权和使用权证明的复印件
Food and Drug Administration （食品药品监督 管理局）
Letter Authorization signed by Enterprise 企业签署的授权委托书 Statement of Guarantee on the Authenticity of the Information Submitted 材料真实性保证声明
Enterprise Code Certificate(组织机构代码证) Finance Registration Certificate（财政登记证） Statistics Registration Certificate(统计登记证)
4
STEP 1 Enterprise Name Pre-approval（企业名称预核准）
foreign investors or legal qualification certificate of the corporation and Certificate of Credit Status 外资企业章程，经公证和依法认证的境外投资者身份证 明文件或注册登记证明及资信证明文件 Approval by Development and Reform Commission发展改革部门做出的项目核准批 复
Department Required documents
Administrative License Application 行政许可事项申请书
Feasibility Study Report 可行性研究报告 Letter of Authorization for Receiving Legal Documents法律文件送达授权委托书 Notification of Pre-approval of Enterprise Name企业名称预先核准通知书
business license (Original and copy)工商营业执照或其他核准执业证件 原件及复印件 Articles of Association (Original and copy)公司章程原件及复印件
State tax bureau 国税局 Local tax bureau 地税局
Department Required documents
Application for Medical equipment business License 医疗器械经营许可证申请表 Certificate for Pre-approval Registration of Enterprise Name企业名称预先核准通知书 Organization and Function 组织机构与职能 File directory of Product quality management regulation 产品质量管理制度文件目录
Letter Authorization signed by all investors and
ID card copy of the Mandatary （工商行政管理局）(全体投资人签署的授权委托书以及代理人的 身份证复印件)
Time Scale：3~5 working days
STEP 2 Approval of COC（商务主管部门批复）
Medical equipment business License医疗器械经营企业许可证
signed by property owner)住所使用证明（产权人签字盖章的房产证复 印件） Letter of Authorization for Receiving Legal Documents《法律文书送达 授权委托书》
Commission of Commerce Letter of Authorization and the Copy of ID Card of mandatary授权委托书及受托人身 （商务委员会） 份证复印件
Articles of Association,Identity certificates of