Port communicationApply for Shenzhen medical device business license，Application for medical device business license
Require
? A medical device business license is a must-have document for medical device operating companies.，Establishing a second-category medical device operating enterprise，should report to the province、autonomous region、Registration with the Food and Drug Administration of the People's Government of the Municipality directly under the Central Government；Establishing a third-category medical device operating enterprise，Should reflect on、autonomous region、Review and approval by the drug regulatory department of the municipal people’s government，And issue a medical device business license。
Medical device business license is now post-approval，The industrial and commercial administration department shall apply for approval after issuing a business license.。The "Medical Device Business Enterprise License" is valid for 5 years。
Medical device business licenses can be divided into the following three categories:：Class I medical devices are low risk、Implementing routine management can ensure the safety and effectiveness of medical devices，Like a scalpel、surgical scissors、Manual hospital bed、medical ice pack、Cooling patches, etc.，Its products and production activities are subject to registration management by the local districted municipal food and drug regulatory authorities.。All business activities will be liberalized，No permission or registration required，You only need to obtain a business license issued by the industrial and commercial department。
Class II medical devices are those with moderate risk，Medical devices that require strict control and management to ensure their safety and effectiveness，For example, the common band-aids in our daily life、condom、thermometer、sphygmomanometer、oxygen concentrator、Atomizer, etc.，Its products and production activities are licensed and managed by provincial food and drug regulatory authorities.，Issue "Medical Device Registration Certificate" and "Medical Device Production License" respectively。
Business activities are subject to registration management by the districted municipal food and drug regulatory authorities.;Medical device business license application：Class III medical devices are those with higher risks，Medical devices that require special measures to be strictly controlled and managed to ensure their safety and effectiveness，For example, a common infusion set、syringe、intravenous indwelling needle、heart stent、Ventilator、CT、NMR, etc.，Its products and production and operation activities are separately controlled by the State Administration of、Provincial food and drug regulatory authorities and districted city food and drug regulatory authorities implement licensing management，Issue "Medical Device Registration Certificate" separately、"Medical Device Production License"、If you are not familiar with the process of applying for a medical device business license on your own, you will often have to go through many trips and still not be able to get it.，If you need someone to do it，It’s best to find a professional agency，Specifically, you can apply for a medical device business license from a company with the mission of “educating people with virtue，Aim high；interdependence and coexistence，"Striving for Progress" is the professional business culture of the company，Established on August 19, 2005 in，Headquarters: Futian District, Shenzhen City，Adhering to the most cutting-edge service concept，Have rich experience and social resources，The main business is company registration、Full financial license application、Accounting and auditing services、Comprehensive financial services and various enterprise qualification license applications，：Establishment of financing guarantee company、Small loan company establishment、Pawn shop established、Non-performing asset disposal company Financial services company、New financial leasing、Commercial factoring company、Financial Supermarket Newly Established Insurance Brokerage Company Newly Established，Insurance agency newly established，Private placement registration details/：Futian District, Shenzhen City
About Hong Kong Xintong
Hong Kong Xintong focuses onGuangdong and Hong Kong license plates、Shenzhen Hazardous Chemicals Business License、Shenzhen labor dispatch licenseandShenzhen Charity Foundationapplication services，Assist customers to applyShenzhen travel agency business license、Shenzhen pawn shop business license、Shenzhen auction house license and other mainstream domestic financial licenses，Support enterprises to achieve compliance expansion of cross-border financial business。Also availableODI overseas investment registration、International travel agency registration and other services，Help enterprises expand their presence in international markets。Provide one-stop compliance solutions for enterprises。To learn more，Please contactHong Kong Information Communications Consultant。
