What is a medical device medical device definition
"Regulations for the Supervision and Administration of Medical Devices" (People's Republic of China *** and the State Council Decree No. 650) Chapter VIII of the bylaws of the definition of medical devices refers to the direct or indirect use of the human body of the instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related items, including the required computer software.
Difference between medical devices and pharmaceuticals
Commonly speaking, medical devices are used for treating illnesses and saving lives, which is the same as pharmaceuticals. What is different from medicines is that medicines are mainly used in the human body or on the surface of the body through the pharmacological effect of the efficacy of the medical device is mainly through the physical and other ways to play a role, and sometimes also need the assistance of computer software.
In the use of the desired purpose to be achieved
①Prevention, diagnosis, treatment, monitoring, mitigation of disease.
②Diagnosis, treatment, guardianship, mitigation, and compensation for injury or disability.
③The study, substitution, regulation, or support of anatomical or physiological processes.
④The support or maintenance of life.
⑤ Pregnancy control.
6 Providing information for medical or diagnostic purposes through the examination of samples from the human body.
How to determine whether a medical device falls into the category of medical devices
①Whether it is used in the human body.
②Whether it meets one of the four intended uses specified in the definition.
③Whether there is a theoretical basis to support the achievement of the intended effect.
④Is there clinical validation.
5 Whether there is a drug or metabolism or immunity playing a major role.
Medical devices are divided into several categoriesThe first category refers to medical devices whose safety and effectiveness are sufficiently ensured through routine management
such as surgical instruments (knives, scissors, pliers, forceps, hooks), scraping boards, medical X-ray film, surgical gowns, surgical hats, examining gloves, gauze bandages, drainage bags and so on.
The second category refers to its safety, effectiveness should be controlled medical devices.
such as medical suture needles, sphygmomanometers, thermometers, electrocardiographs, electroencephalograms, microscopes, acupuncture needles, biochemical analysis systems, hearing aids, ultrasound disinfection equipment, non-absorbable sutures, condoms and so on.
The third category of medical devices that are potentially dangerous to the human body and whose safety and effectiveness must be strictly controlled.
such as implantable cardiac pacemakers, corneal contact lenses, artificial crystals, ultrasound tumor focusing knife, hemodialysis devices, implantable devices, vascular stents, comprehensive anesthesia machine, dental implantable materials, medical absorptive sutures, intravascular catheters and so on.
Medical device license medical device license application conditions
① with the scale and scope of operation of the quality management organization or quality management personnel;
② with the scale and scope of operation of the relatively independent premises;
③ with the scale and scope of operation of the appropriate storage conditions
④ should establish and improve product quality management system, including procurement, purchase and acceptance, warehousing and storage, etc.;
⑤ with its operation of medical equipment products appropriate technical training and after-sales service capabilities, or by a third party to provide technical support.
Medical device license application materials
According to Maigoo network editors, the application materials include:
①Medical device license application form;
② business license and organization code certificate copy;
3 legal representative, the person in charge of the enterprise, the person in charge of quality of the identity of the person in charge of the identification, education, or proof of title Copy;
④ organization and departmental setup;
⑤ business scope, business mode description;
⑥ business premises, warehouse address location map, floor plan (indicating the actual area of use), documents proving ownership of the house or a copy of the lease agreement;
⑦ business facilities and equipment directory;
⑧ quality of operation Management system, work procedures and other documents directory;
9 computer information management system and functional description of the basic information;
⑩ proof of authorization of the operator;
_Other supporting materials.
Medical Device Business License Application Process
Prepare materials → submit application materials to the local Drug Inspection Bureau → pass the inspection of the Drug Inspection Bureau → obtain the "Medical Device Business License" → registered capital in place → obtain a business license → obtain the organization code certificate → obtain the tax registration certificate → delivery of the materials → end
Medical Device Business Filing Process
Medical equipment sales medical equipment sales good to do
Medical equipment sales is still relatively good to do, because the market for medical equipment is relatively large, there is a certain development prospects, but the pressure will be relatively large, especially for the first time into the sales industry, the network is limited, the pressure is too great.
Medical device sales salary income
100%90%80%70%60%50%40%30%20%10%03K-4.5K1.9%4.5K-6K11.7%6K-8K24.6%8K-10K21.7%10K-15K28.3%15K-20K9.1%20K- /p>
Analyze the business
Examine the situation of the products that the company has already sold out, such as what hospitals it has sold to, how it has been sold, and what are the reasons for purchasing it? What is the effect of actual use? How about the sales price? It is best to ask the boss and colleagues clearly. In addition, it is best to have purchased the product to the hospital site visits a few times, listen to people use feedback, it is best to take a picture back.
Analysis from the public relations
51Dongshi editorial reminder do not come up to talk to people about cooperation, talk about cooperation in the pre-talk about a can, the rest of the large amount of effort is to establish friendship. In their own run through the customer to pick out two to three key customers to do tracking and re-visit.
Medical equipment procurement medical equipment buyer good to do
Medical equipment buyer involved in a huge amount of money, the responsibility is very important, they need to spend enough time and energy to study the business, so we can see that the medical equipment buyer's job is not as easy as imagined.
Medical equipment procurement process
Procurement plan development process → qualified supplier selection → procurement contract signing process → selection of purchase products and specifications → the first business varieties of the approval process → according to the procurement process.
Medical equipment purchasing attention
①To check and request the relevant business license, and retained for archiving.
②To obtain the identity of the relevant business personnel and the person in charge of the enterprise entrusted the original sales authorization.
③To check the product registration certificates and product qualification certificates of the medical devices you buy.
④To check on the spot that the purchased devices are intact.
⑤Do not purchase medical devices that are unregistered, without certificates of conformity, expired, invalid or obsolete.
How to do a good job as a medical equipment buyer
1, to be familiar with the laws and regulations on medical supplies and procurement.
2, 51Dongshi editors reminded to be familiar with the basic knowledge of common medical equipment.
3, to be familiar with the basic theory of procurement management.
4, to often communicate with the use of personnel, timely understanding of customer needs.
5, to ensure the smooth flow of information with the treasurer, at any time to grasp the inventory status.
Medical device company ranking ranking company name fiscal year sales ($ dollars) 1 Medtronic 289130000002 Johnson & Johnson (Medical Devices Division) 259630000003 Royal Philips 218081508004 GE Healthcare 199420000005 EssilorLuxottica194663660006 Siemens Healthcare161865240007CardinalHealth(medical section)154440000008Shisek148840000009MedlineIndustries13900000000View detailed rankings>>Recommended reading01What are the commonly used medical devices in the homeHome healthcare Equipment purchase strategy With the progress of society and the improvement of the standard of living requirements, more and more people's self-care awareness, health awareness is constantly strengthening, home medical...
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