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北京材料 医疗器械网络销售备案,医疗器械二类备案,三类经营许可证代办,用户第一


(四)医用材料类:二类、三类:6863口腔科材料,6864医用卫生材料及敷料,6865医用缝合材

料及粘合剂,6866医用高分子材料及制品 (五)体外诊断试剂类(属医疗器械管理):二类、三类:6840体外诊断试剂。

(六)一次性使用无菌医疗器械类:三类:6815注射穿刺器械,6866-1医用高分子材料及制

品 (七)软件类:二类、三类:6870软件(八)验配类:三类:6822-1医用光学器具、仪器及内窥镜设备(角膜接触镜及护理用液);二类:6846-5植入材料和人工器官(助听器)。

第七条药品零售兼营医疗器械企业的经营范围: (一)器械类:二类:6815注射穿刺器械,6820普通诊察器械,6827中医器械,6841-4医用化验和基础设备器具,6866-3、7医用高分子材料及制品。

二设备、器具类:二类:6821医用电子仪器设备,6823-6医用超声仪器及有关设备,6826物理治疗及康复设备,6854-8手术室、急救室、诊疗室设备及器具,6856-2病房护理设备及器具 (三)医用材料类:二类:6864-2医用卫生材料及敷料。

 How to handle the business license of class III medical devices
1. The business license of Class III medical devices is handled as follows:
(1) The applicant shall submit the application materials to the relevant departments;
(2) Relevant departments shall accept the application of the applicant;
(3) Investigate the actual site and audit the products;
(4) Grant the issuance of a class III medical device license.

Three kinds of medical devices as the highest risk in the medical device classification category, strictly by the supervision and management, but for many families of three kinds of medical devices, many basic problems is not fully grasp, today we will take a look, what are three business scope of medical devices? How to apply for the three types of medical equipment business license again!


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