Port communicationDifficulties in handling medical device licenses in Shenzhen|
Process
Revealing the secrets of Category 1 - No need to apply for a medical device license. Category 1 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。
Category II - The Municipal Food and Drug Administration handles medical device business registration. Category II medical devices have moderate risks.，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.;Category III - The State Food and Drug Administration applies for a medical device license. Category III medical devices carry 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"、"Medical Device Business License" The medical device business license is a must-have certificate for medical device operating companies.，Establishing a second-category medical device operating enterprise，should report to the province、autonomous region、Registration with the Drug Supervision and Administration Department 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 issued a "Medical Device Business Enterprise 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:：What is the purpose of issuing new registration management measures in Shenzhen?
As the number of medical institutions established in Shenzhen doubled，The original management regulations and management methods no longer meet the existing needs；at the same time，This measure is to encourage social forces to establish medical institutions in accordance with the law，Meet the needs of social capital to run medical services and reflect the government's reform measures to decentralize regulation and improve services，At the same time, we also learn from the practices of other cities.，Results based on the development status of Shenzhen’s medical industry，Medical institution practice license
Process
More simplified、clear。
Which department handles the processing of practice licenses for medical institutions? Municipal and district-level health administrative departments are responsible for the registration of different types of medical institutions.，Among them, various types of outpatient departments、Social welfare center、Traditional Chinese Medicine Clinic、Health clinics and other prescribed medical institutions shall be reviewed at the district level；in addition，Some larger hospitals、Seven types of medical institutions, including nursing homes, are placed under municipal registration。
Conditions for applying for medical institution practice license：1.The non-profit medical institution has obtained approval for its establishment，For-profit medical institutions have obtained commercial entity qualifications；2.Requires approval from the national or Guangdong Provincial health administrative department，Relevant approval documents should also be obtained；3.Comply with the standards for setting up medical institutions set by the municipal health administrative department；4.The name of the medical institution complies with relevant regulations；5.The person in charge of the medical institution shall not commit any violation of regulations or disciplines；6.Public medical institutions should also comply with the medical institution establishment plan formulated and issued by the municipal health administrative department.。
、How long is the validity period of the medical institution practice license? For the sake of effective management，Depending on whether there are beds (whether there is scale or not)、strength)，Issuance of medical institution practice licenses with different validity periods，5 years for those without beds，15 years with beds，Upon expiration, you can apply for extension procedures within the specified period.。
Specific matters on administrative licensing conditions 1、Legal representative of the enterprise、Business person in charge、Quality management personnel should not have the circumstances specified in Article 40 of the "Regulations on the Supervision and Administration of Medical Devices";2、The enterprise should have a quality management organization or full-time quality management personnel that is commensurate with its business scale and scope.;Quality management personnel should have relevant professional academic qualifications or professional titles recognized by the state，Professional and technical personnel who have been qualified in accordance with the law。
For example, the quality manager should be on-the-job，Not allowed to work part-time in other units3、Have a relatively independent business location that is commensurate with the business scale and scope of business。4、Have storage conditions suitable for the business scale and business scope(storage device、facility)。5、Have technical training on operating products、After-sales service capabilities。6、Should be based on relevant national and local regulations，Establish and improve the necessary quality management system，and strictly enforce。
7、National standards for medical devices should be collected and preserved、Industry standards and regulations on medical device supervision and management、Regulations and special provisions。8、Passed the acceptance inspection in accordance with the "Implementation Standards for the Acceptance of Medical Device Business Enterprises in Guangdong Province"。
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