入园流程 ENTRY PROCESS
国际创新药械产品落地乐城流程图
Boao Lecheng Flow Chart for International Innovative Medical Products
药械（授权）企业 介绍海外上市药械产品
International Medical Company
Intends to introduce a medical product in Boao Lecheng
Intends to introduce a medical product in Boao Lecheng
乐城医疗机构 有引入该产品的意向
Boao Lecheng Medical Institute
Intends to use the medical product
Intends to use the medical product
签约 乐城医疗机构，境外药械厂商，物流代理之间签订协议
Agreement
The Boao Lecheng Medical Institute shall sign an Agreement with the International Medical Company either directly with the International Medical Company or through a logistics agent
The Boao Lecheng Medical Institute shall sign an Agreement with the International Medical Company either directly with the International Medical Company or through a logistics agent
提交申请
药械（授权）厂商：提供产品相关资料，适时开展产品使用培训
乐城医疗机构：作为申请主体，在特许药械追溯平台上提交申请资料
Application Submission
International Medical Company: Provides documents, offers training in the product use
Boao Lecheng Medical Institute: Submits application documents to the Lecheng E-Tracing System
乐城医疗机构：作为申请主体，在特许药械追溯平台上提交申请资料
Application Submission
International Medical Company: Provides documents, offers training in the product use
Boao Lecheng Medical Institute: Submits application documents to the Lecheng E-Tracing System
审批
首次 — 海南省卫健委（3工作日）、药监局（7工作日）
非首次 — 乐城医药药品监督管理局（5工作日）
Screening & Approval
Approval of the First Lot of the Product: Hainan Health Commission Decision < 3 working days
Hainan Medical Products Administration Decision < 7 working days
Approval of Subsequent Lots of the Product:
Boao Lecheng Medical Product Administration Decision < 5 working days
非首次 — 乐城医药药品监督管理局（5工作日）
Screening & Approval
Approval of the First Lot of the Product: Hainan Health Commission Decision < 3 working days
Hainan Medical Products Administration Decision < 7 working days
Approval of Subsequent Lots of the Product:
Boao Lecheng Medical Product Administration Decision < 5 working days
生物制品 办理检验检疫备案
Biological Products
Registration for Inspection & Quarantine
Registration for Inspection & Quarantine
非生物制品 无需检验检疫备案
Non-Biological Product
No Registration or Quarantine
No Registration or Quarantine
进口物流
乐城医疗机构委托具备药品、医疗器械经营资质的物流代理商
进行采购、进口、配送
Overseas Shipment
The Lecheng Medical Institute retains a eligible logistics agent. which is licensed for trading drugs or medical devices to procure, import and deliver the product
进行采购、进口、配送
Overseas Shipment
The Lecheng Medical Institute retains a eligible logistics agent. which is licensed for trading drugs or medical devices to procure, import and deliver the product
入库
药械厂商可以提前发货，将产品存储在乐城保税仓
Stock-in
The International Medical Company may arrange shipments in advance of a final approval and store the product in the Boao Lecheng Public Bonded Warehouse
Stock-in
The International Medical Company may arrange shipments in advance of a final approval and store the product in the Boao Lecheng Public Bonded Warehouse
乐城保税仓
入库、出库
Boao Lecheng Public Bonded Warehouse
Stock-in
Stock-out
Boao Lecheng Public Bonded Warehouse
Stock-in
Stock-out
出库
按批条数量对产品清关，出库送至乐城医疗机构
Stock-out
Customs clearance of approved quantities of the product by the logistic agent after which the agent delivers the product to the Boao Lecheng Medical Institute
Stock-out
Customs clearance of approved quantities of the product by the logistic agent after which the agent delivers the product to the Boao Lecheng Medical Institute
产品使用 乐城医疗机构使用特许药械产品
Use of Product
Lecheng Medical Institute uses the product
Lecheng Medical Institute uses the product