1.二類醫療器械備案申請書

2.營業執照或預先核名通知書

3.法定代表人、企業負責人、質量負責人的身份證明、學歷或者職稱證明復印件

4.經營場所、庫房地址的地理位置圖、平面圖、房屋產權證明文件或者租賃協議(附房屋產權證明文件)復印件 5.產品經營目錄表

6.產品合格證書

7.上家購銷合同、進貨渠道

注：二類醫療器械備案有效期為長期，到期前6個月到所在地設區的市級食品藥品監督管理部門換發二類醫療器械備案新憑證

edical devices 2. Business license or pre-check name notice 3. Copy of the identity certificate, education background or professional title certificate of the legal representative, the person in charge of the enterprise and the person in charge of 4. Copy of the geographical location map, floor plan, house property right certificate or lease agreement (attached with the house property right certificate). 5 6. Product certificate 7. Last home purchase and sales contract and purchase channels Note: The validity period of class II