- 一類產品備案
- 二類產品注冊
- 三類產品注冊
- 產品分類確定
國產一類醫療器械備案服務
Registration service of domestic Class I medical device
備案產品技術要求撰寫輔導及服務；
產品檢測（自測）； 質量管理體系輔導；
產品備案資料撰寫及輔導服務；
產品備案資料提交，備案憑證的領取。
Registration product technical requirements writing counseling and services；
product testing (self-testing)；
quality management system counseling,；
product registration information writing and counseling services,
Submitted product registration materials and received registration vouchers.
國產一類醫療器械備案
Registration of domestic class I medical device
備案人準備材料：
產品說明書（至少包括：產品照片、型號規格、結構原理特性、性能參數）；
產品的性能指標及檢驗方法；生產工藝提供（工藝流程圖（須注明主要控制點，即關鍵工序和特殊工序）主要組分的具體生產過程）；
授權委托書。
The registrant prepares the materials：
product specifications (including at least: product photos, model specifications, structural principles characteristics, performance parameters);
product performance indicators and inspection methods; Production process provision (process flow chart (must indicate the main control points, that is, key processes and special processes) of the main components of the specific production process);
Power of Attorney.
備案流程
Registration process
項目 Item | 客戶工作 Customer work | 華光泰和工作 Medadmt work |
前期準備 Preparation in advance | 提供企業及產品基本情況 Provide basic information about enterprises and products | 了解客戶基本信息 Understand basic customer information |
| 產品技術要求、產品說明書 Product technical requirements, Product specification | 對照模板填充內容 Fill content against template | 提供技術要求模板、審核產品技術要求和說明書 Provide technical requirements template, review product technical requirements and specifications |
產品自檢報告 Product self-test report | 確定產品技術要求和說明書，編制產品檢驗記錄或委外檢測 Determine product technical requirements and specifications, prepare product inspection records or outsourced testing | 如果產品需要外檢，協助外檢 If the product needs external inspection, assist in external inspection |
| 產品備案資料 Product Registration materials | 提供基礎信息 Provide basic information | 編寫備案資料 compile registration materials |
備案申報 Registration declaration | 準備產品備案資料打印蓋章 Prepare product registration materials for printing and sealing | 整理上報資料，上傳蓋章掃描件 跟蹤備案進度，領取備案憑證 Sort out reported materials and upload stamped scanned copies Track the registration progress and get the registration voucher |
體系審核 System audit | 準備體考資料、 迎接體系審核 Prepare system assessment materials, Prepare for system audit | 輔導準備體系考核資料（如需） 對體系考核資料進行初步審核（如需） Assist in preparing system assessment materials (if required) Preliminary review of system assessment data (if required) |
項目結項 Project closure | 接收備案資料并歸檔 Receive registration materials and file them | 整理備案資料交給甲方 Organize and submit the registration materials to Party A |
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