Port communicationover the years，The medical device market is becoming more and more prosperous，The number of medical device sales companies is also increasing。but，For some companies that have just learned about medical devices，Maybe you don’t know much about the laws and regulations on medical devices，I don’t know what qualifications are needed to operate medical devices.。The editor of Hong Kong Xintong has compiled the following content about the qualifications required for medical devices.。
Medical devices are divided into three levels according to risk levels，Production、The qualifications and permissions required to operate vary.，Let’s introduce it from the level：Class I medical devices refer to low-risk medical devices that can be guaranteed to be safe and effective through routine management，Such as gauze、scalpel、Cooling patches, etc.。Production activities need to be recorded；Business activities are fully liberalized，Only need to obtain a business license issued by the industrial and commercial department，No need to register or obtain business license。
Class II medical device is a medium-risk medical device，Requires strict control and management，to ensure its safety and effectiveness，Such as band-aids common in daily life、condom、thermometer、Sphygmomanometer etc.。Production activities are registered and managed by the provincial food and drug supervision and administration department.，The Provincial Food and Drug Administration issued "Medical Device Registration Certificate" and "Medical Device Production License" respectively；Business activities shall be registered by the food and drug supervision and administration department of the city divided into districts.。
Class III medical devices are high-risk medical devices that require special measures to be strictly controlled and managed to ensure their safety and effectiveness.，Like an ordinary infusion set、syringe、intravenous indwelling needle、heart stent、Ventilator、CT etc.。
All its production and business activities need to be approved by the State Administration of、Provincial food and drug administration departments and districted city food and drug administration departments conduct licensing management，Both need to obtain a "Medical Device Registration Certificate" and a "Medical Device Production License" and a "Medical Device Business License" respectively.。
Individual Category II、The registration and license application for Class III medical devices will be more difficult.，For details about their process, please refer to previous articles.，The editor of Hong Kong Xintong recommends finding a professional and mature agency to handle it.，Will save more energy。However, it is important to make a decision based on the actual situation and personal preferences.。
The above is medical device production、business、Contents required for sales qualifications，If you have any questions or ideas, please leave a message or private message to communicate with the editor of Hong Kong Information Communication，I will always be waiting for your arrival~Related products：Medical device qualification introduction
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