第一類醫療器械是指，通過常規管理足以保證其安全性、有效性的醫療器械。

一類醫療許可證無需辦理經營許可證。如果是生產醫療器械，則需要到相關部門備案。

二、公司增加二類醫療器械經營范圍

二類醫療器械備案要求，根據《醫療器械監督管理條例》凡是從事二類醫療器械經營的單位都需要到所在地設區的市級食品藥品監督管理部門備案，二類醫療器械是具有中度風險，需要控制管理以保證其安全、有效的醫療器械。如：醫用縫合針、血壓計、體溫計、心電圖機、腦電圖機、顯微鏡、針灸針、生化分析系統、助聽器、超聲消毒設備、不可吸收縫合線等。

要求：

1.商用性質辦公60平，倉儲40平

2.2名醫學專業人員為企業負責人

3.產品經營目錄

注：符合以上3點，基本上就可以辦理二類醫療器械備案

s not need for a business license. If it is making medical devices, it needs to be filed with the relevant departments. 2. The company has increased the business scope 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, a