鏡、超聲手術(shù)刀、彩色超聲成像設備、激光手術(shù)設備、高頻電刀、微波緩解儀、醫用核磁共振成像設備、X線(xiàn)緩解設備、醫用高能設備、人工心肺機、內固定器材、人工心臟瓣膜、人工腎、呼吸麻醉設備、一次性使用無(wú)菌注射器、一次性使用輸液器、輸血器、CT等。

三類(lèi)申請醫療器械經(jīng)營(yíng)許可證條件：

1.具有與經(jīng)營(yíng)規模和經(jīng)營(yíng)范圍相適應的質(zhì)量管理機構或者專(zhuān)職質(zhì)量管理人員。質(zhì)量管理人員應當具有國家認可的相關(guān)專(zhuān)業(yè)學(xué)歷或者職稱(chēng)；

2.具有與經(jīng)營(yíng)規模和經(jīng)營(yíng)范圍相適應的相對獨立的經(jīng)營(yíng)場(chǎng)所；

3.具有與經(jīng)營(yíng)規模和經(jīng)營(yíng)范圍相適應的儲存條件，包括具有符合醫療器械產(chǎn)品特性要求的儲存設施、設備；

4.應當建立健全產(chǎn)品質(zhì)量管理制度，包括采購、進(jìn)貨驗收、倉儲保管、出庫復核、

nized by the state; 2. Having a relatively independent business site commensurate with the scale and scope of business; 3. Having storage conditions suitable with the scale and scope of business, including storage facilities and e that meet the re of the characteristics of medical device products; 4. The product management system shall be established and improved, including procurement, purchase and acceptance, warehousing, warehousing and review, and