2011/05/01

Toothache when eat sweet

Each time to eat sweet, severe tooth pain hot foods, brushing teeth is also afraid of cold water bleed easily, is this what dental?

Patient information: Male 25 years old
Condition described in (time of onset, the main symptoms, etc.):
Around one and a half ago, and now increasingly serious. The main symptoms, teeth sensitive to cold, hot, sweet, brush your teeth will be painful case of toothpaste, easy bleeding.

How do want to help:
What is the dental? How should the treatment, the treatment will not be very troublesome pain? What causes, how to avoid?

Situation and whether there was allergy treatment, genetic history:
No

Recommend that you go to regular oral hospital once the symptoms show you: It may be of dentin hypersensitivity and periodontitis, you should make the system of treatment, no pain.

May be lit, and recommended to eat three days of cephalosporin and metronidazole look good, if not the best view to the hospital as soon as possible, to find a regular dental hospital, dental problems can be very flexible.

Block off one of those dental teeth

Patient information: Male 27 years old in Jiaxing, Zhejiang
Condition described in (time of onset, the main symptoms, etc.):
The middle of a piece of tooth out, and continues; over time to swap a small piece, now have a big hole in the middle, usually does not hurt, that is, there will be pain when eating stuffed.

How do want to help:
What is dental, how governance

Caries, have been exposed nerve, and went to the dentist then look at it, if the nerve did not humus, as long as the detritus of teeth after removing make up on it, if the nerves have been eroded to do root canal therapy, and Suggest early treatment, or more off the teeth will more likely to do after the porcelain teeth

While your teeth still strong, I suggest you go to dental hospital to check, and can now do beauty crown, porcelain teeth, dental implant, etc., see a doctor sooner, the more your choice.

Did not know you are out of teeth or dental calculus ah, if it is to be a dental check as soon as possible to the hospital, there are problems in time

Should be tooth decay, or dental fluorosis.
Need to do first root canal treatment
Then make a crown protected on it

Your friends do not worry, this proposal should be repaired to the local hospital can be a dental

Some of my dental problems

What age number of people who have dental?
The number of men and women of the dental and more?
How many times do the average annual dental care is the best?
Trouble attach a small paper, talk about reading the views of dental problems and how to protect the teeth.


To protect the teeth, we must first understand the structure of teeth. Teeth are the hardest organs in the body. Are biting cut, tear, grind food and to help pronunciation and so on. Human life has two teeth: one for the teeth, a total of 20 on each jaw 10. After birth around about six months of eruption of a homogeneous two and a half years, from 7 to 12 years of age, primary teeth have exfoliated; another deputy for the permanent teeth, a total of 32, the upper and lower jaw of the 16, from 6 years of age , was gradually replaced teeth, in addition to 12 years after the first 3 molars, the eruption of permanent teeth all. 3 molar eruption usually after the age of 20, also known as wisdom teeth. Wisdom teeth can also be no life, so 28 to 32 permanent teeth were normal.

Teeth divided crowns, neck and root of three parts. Crown that we can see part of the teeth exposed on the outside part of the gums. Surface covered with a layer of enamel crowns, enamel is the hardest tissue in the body, hardness similar to quartz. Root is embedded in the upper and lower jaw alveolar process in part. Coated with a layer of root cementum. Between tooth crown and root neck is slightly smaller among some, outsourcing gums. Constituted mainly by the quality of dental teeth, called dental cavities inside the cavity. Teeth cavity filling a living connective tissue, nerves and blood vessels, collectively known as the pulp. Blood vessels and nerves from the apical hole and out. Suffering from dental caries, when the bacterial corrosion of the enamel and dentin into the pulp cavity, stimulate nerves, the pain. (See Figure 37) students to protect their teeth, to do the following:

1. To develop good brushing habits. Rinse with warm water after a meal, brush your teeth morning and evening time. The frequency of brushing is not too much more it will damage the teeth, brushing time should not be too long. Brushing should pay attention to the right way: down the teeth, bristling brush, brushing the inside painted outside. Not scrub back and forth horizontally, otherwise it will damage the gums.

2. Always pay attention to dental health, and protect teeth. Usually to eat less candy. Do not eat candy, especially before going to sleep, prevention of dental caries. Also, pay attention to the usual health habits, not to bite fingers, do not bite a pencil top foreign body, no tongue lick teeth.

3. If the tooth is sick, should be timely medical treatment. In case of bad tooth decay and should be repaired or removed.

To achieve the above points is not difficult, the key is to persevere. Students would like to have a healthy and beautiful teeth.

Have good oral health is not the only way to healthy beautiful teeth. Diet also plays a significant role. Here are some suggestions to help you have a beautiful smile!

Your teeth: the main indicator of health and beauty

Teeth so that we can enjoy a wide variety of food! Healthy teeth allow us to chew hard food cynical, meat, raw food, fruit ... ... good chewing gum can enhance the strength, stimulate saliva production, and their participation in the process of digestion, the teeth play a sterilization role. In addition to genetic factors, the color of our teeth, and hardness also depends on the dental health and eating habits.

In order to maintain dental health: a balanced diet!

Balanced diet, adequate distribution of the meals of the day (to avoid snacking, four meals a day should be arranged in: Breakfast, lunch, dinner and snack time) on the strong teeth are very favorable. In fact, this enables us to better resist the stimulation of teeth: enamel erosion, dental caries ... ... fresh foods, such as carrot, red radish, or Apple is chewing at the right time, the friction surface of the teeth, in fact, from to the role of clean teeth. In addition, lipids, certain proteins (casein cheese), minerals (phosphorus, calcium, fluoride ... ...) of vitamin D also has an antibacterial effect, limiting the salt discharge enamel.

In contrast, snacks, especially those "soft" food, carbohydrate food (candy or sweet drinks, bread, pastries ... ...) or acidic foods (soda, fruit, fruit juice), usually increases the risk of tooth decay. Sugar can be converted to acid, the acid could damage the surface of the tooth enamel. If possible, every time after eating food carefully clean teeth. If there are no conditions, but also can seriously mouthwash or chewing a piece of sugarless gum. In fact, any increase in saliva flow rate are reduced risk of dental caries. To point out that excessive consumption of coffee, tea and smoking too much may make the teeth yellow.

Four dairy products make teeth stronger

They are what we need the best quality of calcium and phosphorus sources, tooth enamel and root support for the main mineral of bone material. Primary teeth begin to mineralize the first four months of gestation, stone tooth mineralization began in the first year of birth. After tooth formation, enamel updated and has been maintained. We should drink milk, it is best not to drink sweet drinks. Dairy products (yogurt, etc.) also brought calcium, phosphorus and vitamin D, which will increase the absorption of calcium and phosphorus. Finally, casein, the major milk protein, can limit the discharge of excessive tooth enamel mineral. The practice of the past, people on the good: usually eat dessert after eating cheese, thanks to the restrictive effect of casein and milk fats, reduce the acid secreted carbohydrates.

Drink mineral water, it is a natural source of fluorine

Natural mineral water to meet the demand of the human body for the fluoride. Fluoride can increase the tooth enamel and teeth, protect teeth from microbial erosion. Most of the mineral water contains 0.3 milligrams per liter of fluoride, but also some content of up to 8 milligrams per liter. We can also see the fluorinated table salt. For pregnant women and children, as well as made use of fluoride tablets (based on age, 0.5 mg to 1 mg). In tea, fish and some vegetables (spinach, red radish ... ...), also contains fluoride quality. However, excessive intake of fluoride quality (more than 2 mg per day) may cause the teeth black.

Use of the benefits of chocolate and sugar-free chewing gum

In fact cocoa contains tannin, quality and calcium fluoride. Protection of these three substances are involved in the work of the teeth.

In the "sugar free" chewing gum, the sugar is replaced by the sweetness of polyols, however, does not cause tooth decay: xylitol to play the role of sterilization will help to reduce dental plaque, as well as sorbitol (synthesized from glucose or fructose sugar, sweet as artificial flavoring agents). Therefore, a 2.2 g sugar-coated chewing gum containing only 3.8 calories.

Dental Consultation

Excuse me, my father, 60, left the following teeth, has lost three teeth. Is a one off, the pre is a little sore, and then slowly getting worse and worse, and finally loose teeth, and then slowly more and more loose, the final out. Each tooth pain tooth to be more than a year, lost a tooth after the tooth next to it will repeat the previous status of a tooth. I do not know what reason? It can prevent dental pain and tooth loss continue?


May be good periodontal, periodontal supporting tissues of teeth mainly, with age, some back teeth Zhou Huisheng rational absorption, coupled with stimulation of periodontal disease, absorption of double loss could eventually lead to loose teeth. The main source of stimulation periodontitis dental calculus, dental calculus formation and maintenance of oral hygiene, personal, individual differences in food preferences and relevant. Department of periodontal root absorption that exposure will cause teeth to become sensitive, especially for hot and cold stimulation. With the deepening of periodontitis, the disease may enter the root through the root tip within the medullary cavity, causing inflammation of the pulp, characterized by spontaneous pain, the pain will become very serious. Your father to recommend to the Department of Oral and Dental Hospital, Periodontal Endodontics look. Periodontal therapy can control the loose teeth, mainly clean teeth. Endodontic therapy can relieve pain, mainly in root canal treatment. However, the specific situation or need to go to hospital when you see it.

Perio-endo lesions, the proposed scaling, as the case for further treatment

Children's Dental to focus on prevention, early treatment

Children's Dental to focus on prevention, early treatment

City children suffer from dental caries 65% -70%

Every parent wants their children to have a good dental health. So, what common children's dental problems, the parents whether the existence of errors in cognitive, child dental should the how? Recently, Jiangsu Provincial Stomatological Hospital, physician, director of children's dental Professor Zhu Lingfu remind parents: dental caries in children is the key to early detection, early treatment and regular inspection, preventive dental, dental oral health needs of love since childhood.

"Children's dental caries has long been the most common oral diseases. Studies show that children suffer from tooth decay rate of the city 65% ​​-70%." Zhuzhu Ren said cavities commonly known as tooth decay, cavities, is an extremely common and the incidence of high disease. Caries can occur at any age, especially in higher prevalence among young people. The incidence of dental caries in children and living environment not only material conditions, but also with the development of tooth structure itself, eating habits and oral health related to the situation.

Caries first appeared, there is no sense in children, but does not cause pain, and some parents even "kids do not need fillings," "Anyway, they wanted to change teeth" and other errors. As everyone knows, if not promptly treated, may cause pulp disease, when inflammation continues to develop into the root, or even cause systemic disease.

Adult children do not appear typical of the general dental teeth spontaneous pain, night pain, but showed significant swelling of the gums. "Therefore, when parents help their children brush their teeth, if found to decay with children should immediately see dental, early treatment and delay in treatment will increase the child's pain." Zhu Zhuren introduced in relatively shallow cavities, the time to can be mended. Involving dental nerves, causing pulpitis to do endodontic treatment, the treatment at least 2-3 times to make good. If the lesion further development, was severely damaged teeth, the teeth can not keep the gap to be done after removal of retainer.

Parents are very concerned for the prevention and treatment issues, Zhuzhu Ren said that parents must pay attention to oral health among children, morning and evening brushing, mouthwash after meals, master the correct method of brushing. Not a partial eclipse, not unilateral chewing. Meanwhile, on a regular basis for an oral examination is also essential, typically 3-6 months.


Link: Children's Hospital of Jiangsu Province, Dental Branch Dental bear the province's health children's oral medicine, teaching, research, prevention and continuing education centers. Dr. existing sections 3, 6 master to carry out dental treatment for children, including the Conservation and Restoration of dental, oral health care, health management, children's dental trauma treatment, first launched in the province to prevent caries pit and fissure sealant disease and non-invasive treatment of dental filling, also active in the dental phobia in children and disabled children's oral treatment.

Is it the signals for big teeth dental?

[Abstract] everyone has teeth, healthy teeth, gums, full, lived gingival papilla filling teeth, is difficult to see with the naked eye the existence of teeth. Beijing You An Hospital, Capital Medical University, Department of Stomatology, director Chen Shizhang also noted: As women enter middle age, the loss of bone calcium in the beginning, especially after menopause, there will be widened between the teeth and so on.

Everyone has teeth and healthy teeth, gums, full, lived gingival papilla filling teeth, is difficult to see with the naked eye the existence of teeth.

There are two reasons for the increase between the teeth. Some people may be inherent in some teeth, too small, too large so that some parts of the teeth is normal. Pathological teeth increased, it is usually caused by periodontal disease. In particular, the persistence of chronic inflammation, recurrent, resulting in alveolar bone resorption, gingival recession. To a certain degree of gingival recession, root exposure can lead to loose teeth, or even fall off.

Beijing You An Hospital, Capital Medical University, Department of Stomatology, director Chen Shizhang also noted: As women enter middle age, the loss of bone calcium in the beginning, especially after menopause, there will be widened between the teeth and so on.

As a result, the teeth will feel the pain experienced hot and cold sweet and sour. Meanwhile, the exposure of the root is also vulnerable to the accumulation of food debris and plaque occurrence of dental caries. So before and after menopause, women especially vulnerable to dental caries, gingivitis, periodontitis and other dental problems. In addition, menopausal women saliva secretion decreased, weakening the role of oral self-cleaning, coupled with the impact of changes in endocrine levels, many women will experience dry mouth, astringent, burning tongue and other mucosal discomfort, but also prone to recurrent mucosal ulcers, flat moss and other oral mucosal diseases.

So, people with big teeth, how to prevent oral disease should it? Chen Shizhang said: first of all to pay special attention to maintain oral health, to develop sooner or later, the habit of brushing and mouthwash after meals, preferably in the brush while flossing; the same time, every morning and evening can be "call-tooth" training and massage the gums, which can contribute to periodontal blood circulation, increase the resistance of the gum tissue, slowing alveolar bone atrophy; In addition, menopause oral paresthesia occurs, can add some calcium, vitamin and so on. Into the post-menopausal women at least a year to see plays dentist; Once loose teeth, chewing and weak, should seek medical advice.

No dental extractions

Three doctors never easy extraction Evening News, because they know the consequences of severe tooth extraction, if you've got teeth, going to the dentist, the worst result, only one tooth, such as mild symptoms, can kill the tooth nerve , although to avoid dental deterioration, but means Bingya not always restore the health of the state, will take a heavier extraction, extraction appears to be simple, but great harm. 1, the real teeth and dentures 50% difference in chewing ability. Extraction means that the decline in ability to chew. The rate of loss of teeth and tooth extraction is proportional to the amount that you are pulling more teeth, loose teeth fall off faster. 2, dentures because there is no sense of ability. Most of the food will make you lose the fun. This is the doctor does not extraction of the secret.

Dental non-extraction treatment without medication

Because every day the magic brush of a toothpaste containing minerals, work area 53 Old Lee West, just one month, loose teeth, sore allergy disappears, and even gum recession, teeth growing, before dinner Seya's wrong with the old address, before the talk of the town's dental constantly, to the hospital, doctors get a long drill pliers that pretend to pull the tooth. Lao Li is not fragrant like dentures to eat, but also easy to pollution in the mouth, really would rather hurt, than tooth extraction.

Later said the child brought back from the U.S. to "NVC oral paste," said it was the top U.S. dental treatment products, a lot of brush on the line for extraction of friends USA, with less than 2 boxes do not have tooth extraction, said he minerals to supplement the teeth, to teeth, increase nutrition, immediate use, ease toothache the day, once every two weeks, the teeth are strong and, now no longer hesitated a bite did not go through pain, cold and hot sweet and sour are not afraid, but also do not suffer tooth!

Experts pointed out: Under normal circumstances, their teeth will continue to repair a small amount of damage, but once the tooth's "defense system" is broken or serious loss of minerals like calcium, bone loss, like tooth becomes loose, the bacteria will will slip into the tooth dentin below, so that loosening teeth, tooth decay, gum recession, teeth and so the increase to strong teeth will replenish minerals. "NVC" Glister oral paste, oral, MD, United States 8 years after Redman latest scientific findings, the use of nano-method to extract the shells from the deep sea minerals, mainly sand phenol factors, minerals, calcium, bone 128 collagen and other nutrients, as "medical osteoblasts," just like mine every day Note strong teeth, dental cavities to fill the gap. Add to shrinking gums become strong after the full nutrition, enabling support for the teeth, so allergies, gingival recession, bleeding, tooth decay and other problems in order to solve.

NVC oral paste the invention by the media attention, "The New York Times" NVC oral paste made of special reports, and strongly recommended as the preferred oral care. It gingival recession on media reports, treatment, loose teeth, toothache treatment effect is a miracle. American Medical Association and to assist in oral declaration of the Nobel Prize in Medicine Dr. Lei Deman.

Time to solve dental problems

Toothache relief of pain, gingival swelling, pain, hurt air suction. Case of elimination of hot and cold sensitive teeth too sweet lancinating, piercing sense. Remove loose teeth, loose teeth, tooth extraction to avoid possible. Bleeding gums brushing to eliminate bleeding, bleeding and so eat the food. Narrow teeth brushing teeth to eliminate large, Seya, increasing the gap between the teeth. Gingival recession collagen mineral supplements of calcium, so full of gum. Whitening teeth yellow teeth, black teeth, smoke stains, 15-day rapid results. Sand phenol factors and oral ulcers can quickly eliminate dissolved peptide ulcer. I suffer with bad breath saliva lysozyme alone can kill oral bacteria. Tooth decay 128 nutrients, preventing various types of dental problems. Dental calculus dental calculus just 15 days will fall to pieces.

Verified 1 day after global consumer pain, bleeding gums. Short of the mouth odor, mouth pain, dry mouth with ease. 3 days cancellation inflammation, eliminate bad breath, mouth pain, dental formation of protective film, mouth fresh, sweet taste. 15 days of tooth sensitivity, periodontitis, gingivitis disappeared, white teeth, gums and full, do not send teeth fixed. 30 days to fill hole gap tooth loss, dental calculus, plaque, such as problem solving, strong white teeth.

Detection of active promotion of export business to upgrade medical equipment

Business Community April 29 hearing precisely because Yixie industry optimistic about China's development potential and the momentum of export growth, multinational companies are increasing Yixie testing in China input. With the increase in recent years, the standard domestic Yixie work forward, the future of technology services from technology upgrade in competition emerge.

Strong demand for testing services

April 2, SGS-CSTC Standards Technical Services Co., Ltd. (hereinafter referred to as SGS) of Ministry of active service medical equipment medical equipment laboratory opening ceremony was held in Guangzhou. Laboratory was established to integrate and enhance medical device testing services SGS capacity for domestic enterprises to enter international markets Yixie green channel to create one-stop shop to help businesses and medical device products in the international market competition.

SGS Group, the Port Director of Medical Services, said Guan Chun Chao, the newly established Department of Medical Services SGS Life Science Services integration, international certification services, light industrial products and services and medical equipment services to all aspects of active resources, most land to enhance the medical device product testing service capabilities, and Hong Kong region for medical appliance manufacturers to provide a more optimized, more convenient service.

In the eyes of multinational companies Yixie testing with China's medical equipment exports to 30% per year growth rate, foreign companies began to high-end medical equipment in China to invest heavily in product research, can be predicted that China's medical device industry will flourish.

Guan Chun Chao said, SGS Medical Services Division and the establishment of an active medical device laboratory, will be a comprehensive analysis of their own status and medical device product management and market conditions, and provide one-stop solutions to help customers solve, including medical device products design, production, packaging, marketing, products exported to international markets during the various technical problems or confusion.

Meanwhile, another multinational Yixie TUV SÜD also increased efforts to promote efforts, the group medical director of Health Services Greater China, Miss Chen Zhaohui, said: "In recent years, the European Union on imported medical devices have become increasingly demanding of certification body with the professional resources also put forward higher requirements. "

Optimistic comment on China's high-end medical equipment market

2011 ChinaVenture China Investment in China in the 28 Ritz-Carl Shanghai Pudong Hotel. Infinity Private Equity Fund Group's managing partner, said high-Zhe-ming, and now the momentum of business growth in China is very good, he said: "We have 25% to 35% of the medical aspects of the investment, mainly for high-grade , A sharp medical devices, and we are very concerned about intellectual property investment. "

It is reported that Infinity different from other short-term market based purely financial investors exit, the positioning of Infinity is a technology-oriented strategic investors. High Zhe Ming said: "In China, whether pharmaceutical companies or medical device companies, which we are all very interesting. So the key factor, not only in the growth of this market, we can add value. "

Short-term return on investment as the current investors in a trend. "Everyone is playing the game, this is not a problem, which of course is a new security approach, but there are many factors that restrict their access to short-term benefits, including regulatory policy and so on. " In fact, the long-term flickering light Companies should be those value-oriented real business.

Zhe-ming in high opinion, to earn quick money in other particularly important to maintain long-term value. "patience will pay off. sometimes, some investors may not understand your industry, or some private equity will cause some problems, but in emerging markets that happens is very normal, competition is a Good test device. "

National medical device into the high-end market

WASHINGTON national medical device companies are seeking solutions to improve independent innovation capability and competitiveness of high-end market. April 23, the leading medical device companies in China Shandong Weigao Group to join hands with the Chinese Academy of Sciences, released a first batch of high-tech research plans to support the project, the project report had reached 122, which received funding support of Item 8 of the plan, involving polymer materials, blood purification materials, high-tech products such as orthopedic materials. Guide its second research project, the main R & D interests include medical materials, medical supplies, medical equipment and high-tech bio-medicine and other fields, will develop a high level of prices generous diagnosis treatment and products.

China Medical Device Industry Association statistics show that China's medical device manufacturers around 3000, but most small business scale, market power is limited, and in addition to individual enterprises, most are generic high-end medical equipment, improve the Lord, ECG, CT, MRI and other medical devices basically can not see the high-end domestic brands, multinational corporations monopoly over 80% domestic market share. In the ultrasound equipment, magnetic resonance imaging equipment, and other fields, the monopoly of multinational companies share even more than 90%. China Medical Device Industry Association, former vice president of Xerox Cheng said: "This is an absolute monopoly in fact, the result is high prices, but also aggravated the people 'doctor of your' problem."

Weigao Group has worked with Chinese Academy of Sciences DICP cooperation to break the monopoly of the German company, developed a recombinant protein immunoadsorption column, mainly used for dialysis or organ transplant rejection generated. Former domestic cost of each dialysis hemodialysis patients need more than 400 yuan, the annual average per patient more than 60,000 yuan; Viagra realize the localization of high costs can be reduced after each dialysis nearly 50%; China's 200 million people have kidney disease, Gateway products such as the use of high treatment, kidney dialysis each year for the country to save more than 600 million patients.

Accordance with the "Chinese Academy of Sciences - Granville High Group high-tech Research and Development Program" Framework for the development of arrangements for R & D each year 30 million yuan, of which Weigao Group invested 15 million yuan funds, representatives of the Office of Science and Technology of Shandong Province, Shandong Province invested 500 million CAS invested 500 million, Weihai municipal government invested 500 million in basic research, applied research and development, trial production, innovation platform, information and personnel exchanges, so as to carry out comprehensive cooperation.

Question about x-ray scattering line

Medical equipment bed unit / bedside machine X-ray scattering line is how the protection? Keywords: medical device category of medical devices medical device companies in China Network



C-arm X-ray machine X-ray machine prices X-ray machine X-ray machine maintenance pet hand X-ray machine X-ray machine maintenance principles of medical X-ray machine X-ray machine dental X-ray machine X-ray machine prices

Categories Medical Devices Medical Devices Medical device company in China SHANGHAI, classification of medical devices medical equipment medical equipment medical equipment sales network forum Oriental Medical Devices



Ray machines commonly used bedside lead protective curtain, according to the different doses of radiation machine, you need to choose a different lead equivalent lead curtain, on infants and young children, pregnant women and couples planning a pregnancy should put an end to irradiation.

Glass cutting head is in the medical device category types?

Glass cutting head is in the medical device category types?

Are three types of sterile medical devices implanted in the class!

On the website of the Medicines for imported equipment, enter the name of the "glass cutting head ", the search results after 2008 are in accordance with the approved products listed three types of management, in the category 6822

Reference: State Food and Drug Administration data query

What's Medical device products in the category management category 123?

Medical device products in the category management category 123 category What do you mean, respectively,

Medical device classification rules

The first category to regulate medical devices, according to "Supervision and Regulation of Medical Devices", the enactment of this rule.

The second refers to medical devices: the human body alone or in combination with instruments, equipment, apparatus, material or other
Items, including the necessary software. Purpose of use is:
(A) disease prevention, diagnosis, treatment, monitoring or mitigation.
(B) injury or disability of the diagnosis, treatment, monitoring, mitigation or compensation.
(C) of the anatomical or physiological process of investigation, replacement or adjustment.
(D) of pregnancy control.
For the human body by its not the role of pharmacology, immunology or metabolic means, but it may have this
Some means to participate and play a supporting role.

Article III of the Rules for guidance, "medical device category," the formulation and identification of new product registration category.

Classification of medical devices as defined in Article IV, should be based on structural characteristics of medical devices, medical equipment and medical devices used in the form
Mechanical status of the three aspects of the use of a comprehensive decision.
Determine the specific medical devices can be classified according to "medical device classification decision table" (see annex).

Article Criteria of Medical Device Classification
(A) structural characteristics of medical devices
Structural characteristics of medical devices are divided into: active and passive medical equipment medical equipment.
(B) the form of medical devices
Depending on the intended purpose, the use of medical devices classified as a certain form. Of which:
1. Passive devices use forms: liquid transportation saving devices; change in the blood, body fluids equipment; medical dressings; outside
Science instruments; re-use surgical instruments; disposable sterile instruments; implants; contraception and family planning devices; disinfection clear
Cleaning equipment; care devices, in vitro diagnostic reagents, and other passive devices such as auxiliary contact or passive.
2. Active devices use the form: energy treatment equipment; diagnostic monitoring equipment; transmission fluid device; ionizing radiation
Instruments; laboratory equipment, medical sterilization equipment; other active devices or active auxiliary equipment.
(C) the state of medical devices
According to the use of the possibility of damage to the human body, the effects of medical, medical device usage can be divided into
Contact or enter the human body equipment and non-contact equipment, concrete can be divided into:
1. Contact or enter the body Devices
(1) the use of time is divided into: temporary use; short-term use; long-term use.
(2) into contact with human body parts: skin, or cavity; trauma or body tissue; the blood circulation system or central nervous system
System.
(3) active devices out of control into the extent of damage: minor injuries; injury; serious injury.
2. Non-contact body devices
Effect on the medical, which were divided into: Basic does not affect; have indirect effects; have a major impact.

Implementation of Article VI to determine the principles of classification of medical devices
(A) the implementation of the classification of medical devices should be determined according to the classification table.
(B) Classification of medical devices according to their intended use to determine the main purpose and role. If you use the same product objective
And different mode of action, classification should be determined separately.
(C) medical devices used in conjunction with other medical devices should be classified separately; attachment classification of medical devices
Its support of the host should be separated from the case of a separate category in the Annex.
(D) role in several parts of the human body for medical devices, according to the use of high-risk form, the use of state classification.
(E) control function of medical device software and the medical devices are classified according to the same class.
(F) If a medical device can be applied to two categories, should be taken to the highest classification.
(Vii) monitor or main function of medical device products, and its classification of devices being monitored and classification.
(H) The State Drug Administration of the work requires, in need of special supervision and management of medical devices can be adjusted
The entire classification.

Article VII of the competent State Drug Administration medical device classification. Basis of "medical devices category" not
Can determine the classification of medical devices, by the provincial drug administration department under the "Medical Device Classification Rules" pre-sub-
Class, and report to the State Drug Administration approval.

Article VIII of the Rules the following terms mean:
(A) of the intended objectives: refers to the product description, label or promotional materials enumerated, the use of medical devices should be made
Use.
(B) Risk: the risk of injury caused by the occurrence of human possibility and severity of the injury.
(C) the use of period:
1. Temporary: the continuous use of equipment is expected within 24 hours of time;
2. Short-term: equipment expected within 24 hours of continuous use over time within 30 days;
3. Long-term: the continuous use of equipment is expected to more than 30 days;
4. Continuous use of time: the purpose of equipment as expected, there is no interruption to the actual role of the time.
(D) the use of parts and equipment:
1. Non-contact devices: No direct or indirect contact with the device;
2. Surface contact devices: including parts in contact with the following equipment:
(1) skin: only contact with the skin surface of the device is not damaged;
(2) mucous membranes: mucous membrane contact with the device;
(3) damage the surface: surface wound or other injury in contact with equipment.
3. Invasive surgical instruments: With surgery, instruments penetrated all or part of the body through the surface, the contact includes the following
Parts of the equipment:
(1) vascular: invasive vascular and blood on the road a point of contact; as a pipeline to the vascular system, the input device;
(2) Organizational / bone / dentine: invasive tissue, bone and pulp / dentin system, equipment and materials;
(3) blood circulation: contact with the blood circulation system equipment.
(E) implants: Any use of surgery, all or part of the access device or natural cavity in the body; in
After the surgical procedure to stay in the body, or parts of these devices remain in the body at least 30 days or more, these devices are considered
As is the implants.
(F) Active devices: any electric or other energy dependent and not directly by the energy produced by the human body or gravity to send
Play the function of medical equipment.
(G) re-use surgical instruments: refers to equipment used in surgery to cut, cut, drill, saw, grasping, scraping, clamping,
Pumping, folder, or a similar surgical procedure, not connected to any active devices, the processing by certain devices can be re-used.
(Viii) central circulatory system: refers to the human blood circulation in the pulmonary artery, aorta, coronary, carotid, cerebral
Arteries, cardiac veins, the large vena cava, inferior vena cava large.
(Ix) the central nervous system: refers to the brain, meninges, spinal cord.

Whether imports of equipment based medical device classification categories?

I now want to apply for the import agent chemiluminescence apparatus medical equipment production license, does this instrument imported and domestic division of whether the instrument, are based on "Medical Device Category " and classify Ⅰ, Ⅱ, Ⅲ Class, thank you! Please help!

Provide customs clearance of imports tax package freight service.
If you have the goods to be imported back, as long as you arrange shipping to my warehouse to Hong Kong to help you through our tax package customs clearance of imports over procedure is simple, fast and convenient customs clearance, you can save a reasonable high Customs value-added tax, reducing the cost of imports, the import process as long as the freight on it, I Division is specialized in Hong Kong (foreign) tax package to the mainland customs clearance of imports and freight services, hoping to provide import services for you, if looking for me, Please add my nickname

Not the same


Classification is yes, but all imported equipment of the registration certificate (not a production license) by the State Food and Drug Administration review process.

Does the product is produced in the country for it?
If it is in domestic production, foreign manufacturers of brand affixed in accordance with domestic regulatory instruments, the need for manufacturers license, product registration card in the declaration, in accordance with the domestic medical equipment category classification.
If the imported products, but also need to follow the requirements of the directory category by product category, the State Food and Drug Administration to declare up.
Problems in the production license only for the domestic production of equipment are required.


"Imports of medical equipment production license", without this thing. State Food and Drug Administration issued the import certificate of registration of medical devices, according to the audit made ​​three types of standards. chemiluminescence instruments are two types of medical devices in China. ISO13485 approved more To the more difficult