What is the definition of medical devices?
The definition of medical devices in the Supplementary Provisions of Chapter VIII of the Regulations on the Supervision and Administration of Medical Devices (the State Council Order No.650 of the People's Republic of China) refers to instruments, equipment, appliances, in-vitro diagnostic reagents and calibrations, materials and other similar or related items directly or indirectly used in the human body, including the required computer software.
The difference between medical devices and drugs
Generally speaking, medical devices are used to cure diseases and save lives, just like medicines. Different from drugs, drugs mainly act through pharmacological actions in or on the body surface, while medical devices mainly act through physical means, sometimes with the help of computer software.
The expected purpose to be achieved in use
① Prevention, diagnosis, treatment, monitoring and rescue of diseases.
(2) Diagnosis, treatment, monitoring, mitigation and compensation of injury or disability.
③ Research, substitution, adjustment or support of anatomical or physiological processes.
(4) support or maintain life.
⑤ Pregnancy control.
⑥ To provide information for medical or diagnostic purposes by examining human samples.
How to judge whether it belongs to the category of medical devices?
① Whether it is used in human body.
② Whether it meets one of the four expected uses specified in the definition.
③ Whether there is a theoretical basis to support the expected effect.
④ Whether there is clinical verification.
⑤ Whether drugs, metabolism or immunity play a major role.
Medical devices are divided into several categories. The first category refers to medical devices that can ensure their safety and effectiveness through daily management.
Such as surgical instruments (knives, scissors, pliers, pliers, hooks), scrapers, medical X-rays, surgical gowns, surgical caps, examination gloves, gauze bandages, drainage bags, etc.
The second category refers to medical devices whose safety and effectiveness should be controlled.
Such as medical suture needle, sphygmomanometer, thermometer, electrocardiograph, electroencephalograph, microscope, acupuncture needle, biochemical analysis system, hearing aid, ultrasonic disinfection equipment, absorbable suture, condom, etc.
The third kind of medical devices are potentially dangerous to human body, and their safety and effectiveness must be strictly controlled.
Such as implantable pacemakers, contact lenses, intraocular lenses, ultrasonic tumor focusing knives, hemodialysis devices, implant devices, vascular stents, comprehensive anesthesia machines, dental implant materials, medical absorbable sutures, intravascular catheters and the like.
Medical device business license application conditions for medical device business license
(a) there are quality management institutions or quality management personnel suitable for the business scale and scope;
(2) Having a relatively independent business place suitable for its business scale and scope;
(3) Having storage conditions suitable for the business scale and scope;
④ Establish and improve the product quality management system, including procurement, incoming goods acceptance and warehousing.
(5) Having the technical training and after-sales service capabilities suitable for the medical device products it deals in, or providing technical support by a third party.
Application materials for medical device business license
According to Maigoo, the application materials include:
(1) medical device business license application form;
Copy of business license and organization code certificate;
(3) A copy of the identity certificate, education or professional title certificate of the legal representative, the person in charge of the enterprise and the person in charge of quality;
(4) description of organization and department setting;
(5) Description of business scope and mode of operation;
⑥ Geographical location map, floor plan (indicating the actual use area), house property certificate or a copy of the lease agreement of the business premises and warehouse address;
⑦ Catalogue of business facilities and equipment;
(8) Directory of documents such as management quality management system and working procedures;
Pet-name ruby computer information management system basic situation introduction and function description;
Attending the agent's authorization certificate;
_ Other supporting materials.
Application process of medical device business license
Prepare the materials → submit the application materials to the local food and drug administration → pass the inspection by the food and drug administration → get the medical device business license → get the registered capital in place → get the business license → get the organization code certificate → get the tax registration certificate → deliver the materials → end.
Medical device management filing process
Medical device sales. Do medical devices sell well?
The sales of medical devices are still relatively easy to do, because the market of medical devices is relatively huge and has certain development prospects, but the pressure will be relatively great, especially in the new sales industry, with limited contacts and too much pressure.
Medical device sales wage income
100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 1.9% 4.5K-6K 1 1.7% 6K-8K 24.6% 8K- 10K 2 1.7% 10K-60k
From the perspective of business analysis,
Investigate the products sold by the company, such as which hospital it was sold to, how it was sold, and why it was purchased. What is the actual use effect? What's the price? You'd better ask your boss and colleagues first. In addition, it is best to go to the hospital where you bought the product several times to listen to other people's feedback, and it is best to take a photo back.
Public relations analysis
5 1 Ishiabe Shoo reminds you, don't talk about cooperation with others as soon as you start, just talk about cooperation once in the early stage, and the rest is to establish friendship. Pick two or three key customers from the customers you have run through to follow up and visit again.
Is the purchase of medical devices good for medical device purchasers?
The purchase of medical devices involves a huge amount of money and great responsibility. They need to spend enough time and energy to study their business. Therefore, the work of medical device buyers is not as easy as expected.
Medical device procurement process
Procurement planning procedure → selection of qualified suppliers → signing procedure of procurement contract → selection of purchased products and specifications → approval procedure of first-time business varieties → implementation according to procurement procedures.
Pay attention to medical device procurement
(1) Check and obtain relevant business licenses, and save the files.
(2) Obtain the identity certificate of the relevant personnel of the enterprise and the original sales authorization letter of the person in charge of the enterprise.
③ Check the product registration certificate and product certificate of the medical device you purchased.
(4) Verify that the purchased equipment is intact on the spot.
⑤ Do not buy unregistered, unqualified, expired, invalid or obsolete medical devices.
How to do well the work of medical device buyer
1. Familiar with laws and regulations on medical consumables and procurement.
2.5 1Dongshi editor reminds everyone to be familiar with the basic knowledge of commonly used medical devices.
3. Familiar with the basic theory of purchasing management.
4. Communicate with users frequently to keep abreast of customer needs.
5. Ensure the smooth communication with the warehouse keeper and keep abreast of the inventory situation.
Medical device companies rank company name Fiscal year sales ($ NUMBER)/KOOC-0/Medtronic 289/KOOC-0/3000002 Johnson & Johnson (Medical Device Department) 259630000003 Royal Philips 2/KOOC-0/808/KOOC-0/508004 GE Medical/KOOC-0/ 994 20000005 Luxottica1946 636600000154440000008 Stryker1488 4000009 MEDLINE Industries1390000000 View the detailed ranking >> Recommended reading. What are the strategies for purchasing home medical care devices? With the progress of society and the improvement of living standards, more and more people's awareness of self-care and health is constantly strengthened. ...
Matters needing attention in the use of common medical devices in the family With the improvement of people's health awareness, more and more medical and health care devices appear in the family, which is different from those used in hospitals. ...
What are the household medical care instruments for the elderly? With the growth of age, the physical function of the elderly is declining, and it is easier to get various diseases. If you have some family health care at home. ...
What are the five smart medical devices necessary for a smart and healthy family? With the rapid development of intelligent terminals and mobile Internet, the intelligent process of medical and health equipment is also accelerating, and various intelligent medical equipment ...