二、公司增加二類醫(yī)療器械經(jīng)營范圍

二類醫(yī)療器械備案要求，根據(jù)《醫(yī)療器械監(jiān)督管理?xiàng)l例》凡是從事二類醫(yī)療器械經(jīng)營的單位都需要到所在地設(shè)區(qū)的市級食品藥品監(jiān)督管理部門備案，二類醫(yī)療器械是具有中度風(fēng)險(xiǎn)，需要控制管理以保證其安全、有效的醫(yī)療器械。如：醫(yī)用縫合針、血壓計(jì)、體溫計(jì)、心電圖機(jī)、腦電圖機(jī)、顯微鏡、針灸針、生化分析系統(tǒng)、助聽器、超聲消毒設(shè)備、不可吸收縫合線等。

要求：

1.商用性質(zhì)辦公60平，倉儲40平

2.2名醫(yī)學(xué)專業(yè)人員為企業(yè)負(fù)責(zé)人

3.產(chǎn)品經(jīng)營目錄

注：符合以上3點(diǎn)，基本上就可以辦理二類醫(yī)療器械備案

提供材料

1.二類醫(yī)療器械備案申請書

2.營業(yè)執(zhí)照或預(yù)先核名通知書

3.法定代表人、企業(yè)負(fù)責(zé)人、質(zhì)量負(fù)責(zé)人的身份證明、學(xué)歷或者職稱證明復(fù)印件

ope of class II medical devices According to the filing re of Class II medical devices, according to the Regulations on the Supervision and Administration of Medical Devices, all units engaged in the business of Class II medical devices need to file with the food and drug regulatory department of the city divided into districts. Class II medical devices have moderate risks and need to be controlled and managed to ensure their safe and effective medical devices. Such as: medical suture needle, sphygmomanometer, thermometer, electrocardiogram machine, electroencephalography machine, microscope, acupuncture needle, biochemical analysis system, hearing aid, ultrasonic disinfection equipm