醫(yī)療器械三類: | 注冊 |
醫(yī)療器械二類: | 注冊 |
注冊公司: | 網(wǎng)絡(luò)銷售備案 |
單價(jià): | 面議 |
發(fā)貨期限: | 自買家付款之日起 天內(nèi)發(fā)貨 |
所在地: | 直轄市 北京 北京海淀 |
有效期至: | 長期有效 |
發(fā)布時(shí)間: | 2023-11-25 04:41 |
最后更新: | 2023-11-25 04:41 |
瀏覽次數(shù): | 91 |
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4.經(jīng)營場所、庫房地址的地理位置圖、平面圖、房屋產(chǎn)權(quán)證明文件或者租賃協(xié)議(附房屋產(chǎn)權(quán)證明文件)復(fù)印件 5.產(chǎn)品經(jīng)營目錄表
6.產(chǎn)品合格證書
7.上家購銷合同、進(jìn)貨渠道
注:二類醫(yī)療器械備案有效期為長期,到期前6個(gè)月到所在地設(shè)區(qū)的市級食品藥品監(jiān)督管理部門換發(fā)二類醫(yī)療器械備案新憑證
三、公司增加三類醫(yī)療器械經(jīng)營范圍
三類醫(yī)療器械經(jīng)營許可證要求:
1、場地要求:必須是辦公性質(zhì),使用面積要最少達(dá)到60平方米;
2、人員要求:需要有3名相關(guān)人員(公司負(fù)責(zé)人、質(zhì)量負(fù)責(zé)人、質(zhì)量檢查人員)的備案并且持有證書;
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 record validity period of class II medical devices is long-term, and the new record certificate of Class II medical devices shall be issued to the municipal food and drug regulatory department 6 months before the expiration 3. The company has increased the business scope of the three types of medical devices Re for the Business License of Class III Medical Device: 1, site re: must be office nature, the use area of at least 60 square meters; 2. Personnel re: 3 relevant personnel (company respons