Port communicationMany people who operate medical devices are not very clear about what they need to handle for the things they operate.，It is believed that anyone who deals in medical devices needs to apply for a medical device business license。this idea，Actually it is incorrect。today，Hong Kong Xintong will tell you how to judge whether you need to apply for a business license based on the medical devices you operate.。
one、Medical device business license classification：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。
at present，Business operators do not need a license，Just prepare a case for operating Category II business；Those operating Category III medical devices need to apply for a Category III medical device business license。
two、Classification of medical devices：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、ultrasonic scalpel、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.。
Detailed classifications can be found online。
three、Materials required for Category II application filing：1.Class II medical device business registration form；2.Copies of business license and organization code certificate；3.Identity and academic qualification certificate of the legal representative or person in charge of the enterprise；4.Description of corporate organization and department settings；5.Business scope、Method description；6.Business premises、Warehouse address rental voucher、House property ownership documents；7.Business premises、Facilities at warehouse address、Device catalog；8.Certificate of authorization of the person in charge；9.Commitment materials for the authenticity of application materials，Signature and seal of legal person；10.Other supporting materials。
Four、Conditions for applying for a medical device business license for Category III：1.Have a quality management organization or full-time quality management personnel that is suitable for the business scale and scope of business。
Quality management personnel should have relevant professional academic qualifications or professional titles recognized by the state；2.Have a relatively independent business location that is commensurate with the business scale and scope of business；3.Have storage conditions suitable for the business scale and business scope，Including products that comply with the characteristics of medical devices
Require
storage facilities、equipment；4.A sound product quality management system should be established，including procurement、Incoming goods acceptance、Warehousing and storage、Warehouse review、Quality tracking and adverse event reporting system, etc.；5.Should have technical training and after-sales service capabilities suitable for the medical device products it operates.，Or agree to have a third party provide technical support；6.Companies operating sterile and implantable products need to establish computer management systems and computer management systems，Able to ensure effective quality tracking and traceability of products throughout the entire process from purchase to sale.。
five、Materials required to apply for a medical device business license：1."Medical Device Business License Application Form"(1 original copy)；2."Business License"(a copy)；3.Organization code certificate(a copy)；4.legal representative、Business person in charge、Proof of identity of the quality manager、Educational qualifications or professional title certificate(1 copy)；5.Quality manager resume(1 original copy)；6.List of professional and technical personnel(1 original copy)and ID cards of professional and technical personnel、Education certificate、Professional title certificate(1 copy each)；7.Organizational Structure and Department Setup Instructions；8.Business scope、Description of business methods；9.Business premises、Geographical location map of warehouse address、floor plan、Housing property ownership certificate or a copy of the housing rental certificate issued by the housing rental agency。
It is a third-party logistics for medical devices entrusted by warehousing，Provide entrustment contract(1 copy)；10.Business facilities、Device catalog；11.Operation quality management system、Directory of documents such as work procedures, including procurement、acceptance、Warehouse、out of warehouse、Quality tracking、User feedback、Adverse event monitoring and quality incident reporting system and other documents(1 original copy)；12.Basic introduction and function description of the computer information management system installed by enterprises applying for medical device business licenses，Print the home page of the information management system(1 original copy)；13.When applying for enterprise declaration materials，The person handling the matter is not the legal representative or the person in charge of the enterprise himself，The enterprise should submit a "Power of Attorney"(1 original copy)；14.Self-guarantee statement on the authenticity of application materials，Including the catalog of application materials and the company's commitment to bear legal responsibility if the materials are false.(1 original copy)。
After reading the above content，Do you have anything to do with the things you run?，Do you have a certain understanding?，If you still have any doubts，Welcome to Hong Kong Information Communications。
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