医疗器械经营许可证代办周期详解

代办医疗器械许可证机构表示由于我国医疗器械市场规模增速在近五年内均大于全球增速，As a result, my country’s share of medical devices in the world continues to rise，2012Year，my country's medical device market size is 221.9 billion yuan，Only accounts for 9.54% of the global share；And by 2025，医疗器械经营许可证代办周期详解我国医疗器械市场规模占比已经超过19%，more than tripled。

It is expected that the proportion of my country's medical device market will continue to increase in 2025，Reach more than 20%。

one、Medical device business license classification：医疗器械经营许可证代办周期详解

1. A category：Regular management is sufficient to ensure its security、effectiveness of medical devices；
2. Category II：to its security、Medical devices whose effectiveness should be controlled；
3. Category three：Implanted into human body;for support、sustain life；Potentially dangerous to human body，to its security、Medical devices whose effectiveness must be strictly controlled。

two、Classification of medical devices：医疗器械经营许可证代办周期详解

1. Class I medical devices：scalpel handle and blade、Ordinary hemostatic forceps、Bullet pliers、Gauze stripping pliers、Sponge forceps、Handkerchief pliers、Leather pipe pliers、Instrument pliers、micro ear acupuncture、Microthroat needle、micro ear hook、microscopic throat hook、Microscopic gun-shaped wheat tongs、Microthroat forceps、Microscopic needle holding forceps、Corneal forceps、Eye forceps、Eye ligation forceps、gauze bandage、elastic bandage、plaster bandage、band-aid、surgical gown、surgical cap、Face mask、surgical pad、surgical drapes、examination gloves，Finger cot、ear cleaning ball、vaginal scrubber、air cushion、anal bag，lock up、urine collection bag、Drainage bags, etc.；
2. Class II medical devices：such as thermometer、sphygmomanometer、information aid、oxygen concentrator、condom、acupuncture needle、ECG diagnostic equipment、Non-invasive monitoring equipment、optical endoscope、Portable ultrasound diagnostic instrument、Fully automatic biochemical analyzer、Constant temperature incubator、Dental comprehensive treatment instrument、Medical absorbent cotton、Medical skim gauze, etc.；
3. Class III medical devices：such as implantable pacemaker、extracorporeal shock wave lithotripsy、Patient Invasive Monitoring System、intraocular lens、Invasive endoscopy、超声手术刀医疗器械经营许可证代办周期详解、Color ultrasound imaging equipment、laser surgery equipment、High frequency electrosurgery、Microwave therapy device、Medical MRI equipment、X-ray therapy equipment、Medical high energy equipment、artificial heart-lung machine、Internal fixation equipment、artificial heart valve、artificial kidney、respiratory anesthesia equipment、Disposable sterile syringe、Disposable infusion set、blood transfusion set、CT equipment, etc.。

与港信通医疗合作后医疗器械经营许可证代办周期详解

1. 专人一对一对接合作企业，保证按步实施，一条信息便知办理进度；
2. 专注医械资质办理多年，有丰富的经验，抓住每一个时间点，大大节约时间；
3. 专业材料制作，业内资源丰富，一站式提供企业医械资质办理服务，Get your certificate quickly；
4. 合作企业只需提供办理中所需材料，其他工作港信通医疗全程负责，省时省事更省心。

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