中

2





Your location：

Homepage

/

Industry Information

08-16 

The heaviest punishment! Sentences for false medical device registration applications since September

According to the judicial interpretation, in the medical device registration application, those who deliberately provide and use false medical device clinical trial reports and related materials will be convicted and punished as the crime of "intentionally providing false certification documents" or the crime of "producing or selling fake drugs" . Among them, the “crime of deliberately providing false certification documents” can be sentenced to a maximum of 10 years depending on the circumstances; the “crime of producing or selling counterfeit drugs”, according to the Criminal Law, causes death or the circumstances are particularly serious, it is to be sentenced More than 10 years, life sentence, or even death sentence. In addition, the new judicial interpretation stipulates that if the staff of state agencies abuse their power or neglect their duties, leading to the registration of medical devices that use false certification materials, they will also be held criminally liable for “abuse of power” or “crime of negligence of duty”. It is undoubtedly the heaviest punishment to be directly sentenced to clinical trial fraudsters by the two masters, and its deterrence far exceeds the administrative punishment of the drug administration. 2016 was the "first year" of the Drug Administration's "bright sword" for medical device clinical trials. CFDA selected 20 registration applications from 20 companies. As a result, nearly half of them had authenticity problems, and a large number of companies voluntarily withdrew their registration applications. , Which caused a strong response in the industry. In 2017, the drug administration "re-bright sword" for the clinical trial verification of medical devices, and related work is in full swing. Last month, CFDA launched the nationwide 2017 medical device clinical trial supervision and spot check, and the list of the first 10 selected registration items has been announced. At the local level, Hunan and Fujian Food and Drug Administration have also initiated the verification of clinical trials of medical device products under review in the province. The scope of verification in Fujian Province also includes retrospective inspection of certified products. Once data is found to be falsified, the registration certificate will be revoked, and applications from related companies will not be accepted within 5 years. It is still unknown which companies will be fined for suspected clinical trial fraud within this year. Just at this moment, the two high-level universities issued a new judicial interpretation, clarifying that false medical device registration application materials including clinical trial data will be held criminally responsible, and how to convict and sentence them. This adds a particularly heavy deterrent to the 2017 medical device clinical trial verification work. The supervision is becoming more and more strict, and the punishment is getting heavier and heavier. Don't fake it, it will be fruitless! Attachment Interpretation of the Supreme People’s Court and the Supreme People’s Procuratorate on Several Issues Concerning the Application of Law in the Handling of Criminal Cases of Falsification of Registration Application Materials for Drugs and Medical Devices (Adopted at the 1714th meeting of the Judicial Committee of the Supreme People’s Court on April 10, 2017, and adopted at the 65th meeting of the 12th Procuratorial Committee of the Supreme People’s Procuratorate on June 8, 2017, effective as of September 1, 2017) In order to punish the criminal acts of falsifying drug and medical device registration application materials in accordance with the law, and to protect the people’s lives and health rights, in accordance with the relevant provisions of the Criminal Law of the People’s Republic of China and the Criminal Procedure Law of the People’s Republic of China, the law is now applicable to the handling of such criminal cases Some of the problems are explained as follows: Article 1 The staff of non-clinical drug research institutions, drug clinical trial institutions, or contract research organizations who deliberately provide false drug non-clinical research reports, drug clinical trial reports and related materials shall be recognized as the 229th of the Criminal Law "Intentionally providing false certification documents" as stipulated in the Article. If the conduct specified in the preceding paragraph falls under one of the following circumstances, it shall be deemed to be "serious" as stipulated in Article 229 of the Criminal Law, and shall be sentenced to fixed-term imprisonment of not more than five years or criminal detention for the crime of providing false supporting documents, and shall be fined : (1) Intentionally using false experimental drugs in the process of drug non-clinical research or drug clinical trials; (2) concealing serious adverse events related to drugs used in clinical trials of drugs; (3) Deliberately destroying or

08-22 

Original Practical: "Eight Lessons" for Medical Device Sales!

For a medical appliance sales person who keeps pace with the times and works hard, we should keep learning, thinking about ourselves three times a day, and we will give you 8 lessons today, and we will start now~~ first lesson Father said to his son, I want to find you a wife. The son said, but I would like to find it by myself! Dad said, but this girl is Bill Gates' daughter! The son said, if so, you can. Then his father found Bill Gates and said, I found a husband for your daughter. Bill Gates said, no, my daughter is still young! Dad said, but this young man is a vice president of the World Bank! Bill Gates said, ah, this way, all right! Finally, Dad found the president of the World Bank and said, I recommend a vice president to you! The president said, but I have too many vice presidents, too much! Dad said, but this young man is Bill Gates’ son-in-law! The president said , So, OK! Why can't the monsters eat Tang Seng meat? ——This is how business is made. Second lesson A salesperson, a clerk and their manager found an ancient oil lamp when they were walking to lunch. They rubbed the oil lamp and an elf jumped out. The elf said: "I can satisfy each of you one wish." "I first! I first!" The clerk said, "I want to go to the Bahamas, driving a speedboat and being isolated from the world." She flew away. "It's my time! It's me!" the salesperson said, "I want to go to Hawaii, lying on the beach, with a private masseuse, free refills of iced juice rum, and the favorite of my life." ! He flew away. "OK, it's your turn." The elf said to the manager. The manager replied: "I want those two idiots to come back to work immediately after lunch!" ——Always let your boss speak first Lesson Three An eagle sits on a tall tree and rests, doing nothing. A little rabbit saw the eagle and asked it, "Can I sit like you and do nothing?" The eagle replied, "Okay, why not." So the rabbit sat on the ground under the eagle to rest. Suddenly, a fox appeared. It threw on the rabbit and ate it. -To sit and do nothing, you must sit in a very, very high position. lesson Four A bird flew to the south for the winter. It's too cold. It froze and fell on a field. While it was lying there, a cow came over and pulled a pile of shit on it. The frozen bird lay in the dung pile and began to feel warm. The cow dung really warmed it up. It was lying in the warm cow dung, very happy, and began to sing. A passing cat heard the bird calling and hurried over to see what happened. Following the sound, it found the bird under the cow dung, and quickly dragged it out and ate it. 1) Not everyone who shit on you is your enemy; 2) Not everyone who drags you out of the dunghill is your friend; 3) When you are stuck in a dung pile, it is best to close your beak. fifth lesson A man prepares to enter the bathroom to take a shower after his wife has finished taking a shower. At this time, the doorbell rang. The wife quickly wrapped herself in a bath towel and rushed to the door. When she opened the door, neighbor Bob stood there. Before she spoke, Bob said, "If you take off the towel, I will give you 800 dollars." After thinking for a while, the woman took off the towel and stood naked in front of Bob. A few seconds later, Bob handed her 800 dollars and left. The woman wrapped her bath towel and returned to the house. When she stepped into the bathroom, her husband asked her, "Who is it?" "It's neighbor Bob." She replied. "Oh," said the husband, "has he mentioned that he owes me 800 dollars?" ——Sharing important information with shareholders who are in the same boat in time will avoid unnecessary exposure. Lesson Six Once upon a time, a monk and a butcher were good friends. The monk gets up every morning to recite the scriptures, and the butcher gets up every day to kill pigs. In order not to delay their work in the morning, they agreed to wake each other up in the morning. Many years later, the monk and the butcher passed away one after another. The butcher went to heaven, but the monk went to hell. Why? Because the butcher does good deeds every day, he asks the monk to get up and recite the scriptures. On the contrary, the monk asks the butcher to get up and kill every day... -Everything you do is what you think is right, but not necessarily right. Lesson Seven You are driving a car, passing a station on a stormy night. There are three people waiting anxiously for the bus. One is an old man who is about to die, he needs to go to the hospital immediately; the other is a doctor, he has saved your life, you want to repay him in your dreams; there is another woman, she is the person you want to marry in your dreams, maybe missed There is no more. But you can only take another person in your car. How would you choose? I don't know if this is a test of your personality, because every answer has its own reasons. The old man is dying, you should save him first. You also want that doctor to get in the car, because he saved you, this

08-25 

Medical equipment sales: tell your customers, why can't you buy cheap ones!

In recent years, with the implementation of the two-invoice system and centralized procurement policy for pharmaceutical consumables, more and more hospitals and customers are desperately pursuing the "lowest price." The event of winning the bid at the lowest price has recently been raging in the medical equipment circle. It is understandable to reduce the falsely high profits, but blindly pursuing the lowest price and buying cheap ones will ultimately hurt the customers themselves! Let’s talk about it below: Why can’t you buy cheap ones? buy cheap You are happy only when you buy it at the lowest price! It is great when you use it, and you may not be happy once. Cheap things, its total cost may not be low, just make up for the money saved in other aspects. buy good quality The moment of giving money is distressed! I am happy every day when I use it, and I feel very worthwhile. If you buy a piece of equipment within two or three days, there will be some problem repairs, which is not so different from only requiring regular maintenance! Customers desperately lower prices and calculate costs Customers always think that we charge high fees, keep the price down, and count the cost with me. I want to ask him: "Have you calculated the design cost? Are the labor costs calculated? Are the marketing costs calculated? Are the company's normal operating costs calculated? Have management costs been calculated? Are logistics costs calculated? Are warehousing costs calculated?..." Give you a bunch of materials, can you turn it into a finished product? Give you steel and cement, can you build a house by yourself? Give you a needle, can you give yourself acupuncture? Give you a basketball, can you play the NBA? Give you a bunch of materials, you can do it yourself It becomes the floor. Give you a bunch of parts, can you build a CT for me? The premise of service is profit The prerequisite of service is profit. Every company must survive. Profits can be appropriately reduced but not disappear. You take away all the profits that guarantee survival. Who will guarantee the quality of products and after-sale services. Someone has settled the accounts for the purchase of large medical institutions, and only pays attention to the lowest price purchase, and does not solve the after-sales problem outside the warranty period. The final maintenance cost is much higher than the purchase cost! The quality of the product is your choice So expensive, yes, because it is good, so expensive! The product is the quality, the person is the taste! The quality of the product is your choice! There is no such thing as the best product with the least amount of money in the world. The pursuit of perfection, quality first Someone asked: "Can your product be cheaper" I can only say: "I can't give you the lowest price, I can only give you the highest quality. I would rather explain the price for a while than apologize for the quality for a lifetime." In every medical appliance sales, the word “integrity” always comes first, quality issues are the most important, and the quality of products is related to the lives of patients!

08-28 

No configuration certificate is required, domestic CT successfully sold to the top three hospitals!

Government's first purchase: Is it local protection or encouragement of innovation? For the first set of products that meet the requirements of national economic development, represent the development direction of advanced technology, are invested in the market for the first time, do not have market competitiveness for the time being, but have greater market potential and industry leading role, and need key support, the first set of products shall be implemented. Recently, Pan Huasu, the chairman of Mingfeng Medical System Co., Ltd., has finally fallen down. The First Affiliated Hospital of Zhejiang University purchased one of its CT machines. Unlike other companies that require a configuration certificate issued by the government to sell CT equipment, Mingfeng’s CT equipment does not require a configuration certificate. The reason why Mingfeng Medical was able to get the green light, Pan Huasu explained the reason: the product was included in the first set of products in Zhejiang Province and obtained the "entry permit" to open the market. Not long ago, Zhejiang Province issued "Several Opinions on Accelerating the Promotion and Application of the First Set of Products" (hereinafter referred to as the "Opinions"), which clearly stated that the first (set) products should be given priority to key construction and government investment projects, and government procurement will be implemented on a trial basis. The first product (set) first purchase system. Chen Ge, deputy director of the Technical Progress and Equipment Division of the Zhejiang Provincial Economic and Information Commission, said that Zhejiang Province will gradually increase the proportion of the first set of products, lower the threshold for government procurement and state-owned enterprises to purchase the first set of products, especially to increase the first set of procurement by medical institutions. The proportion of large-scale domestic medical equipment in Taiwan. Eliminate corporate worries and promote innovation with applications Since 2007, Zhejiang Province has taken the lead in establishing the first set of insurance compensation mechanisms for major technical equipment in China to promote the application of "Zhejiang Quality Products" in government procurement and engineering construction. Up to now, the province has identified 644 products for the first set, and has issued a total of about 350 million yuan in financial incentives. In 2013, Zhejiang Province took the lead in launching the country's first set of major technical equipment insurance compensation pilot work. Nearly 40 companies have enjoyed provincial and national financial compensation for the first set of insurance, and the accumulated insurance amount exceeded 2 billion yuan. Among them, Hangyang Co., Ltd. insured the "100,000-level large-scale internal compression process air separation complete set of equipment" received national premium subsidies of more than 10 million yuan, becoming the first enterprise in the province to compensate for more than 10 million yuan. Although Zhejiang continues to increase the promotion and application of the first set of products, it is unavoidable that innovation is still "unsafe" for enterprises. Eliminating the concerns of enterprises on scientific research and innovation and promoting innovation and development with applications have become the main purpose of the new policy. The relevant person in charge of the Zhejiang Provincial Science and Technology Department said that the new policy is of great significance to further promote the independent innovation of Zhejiang's equipment manufacturing industry and the transformation of scientific and technological achievements, accelerate market promotion and application, and promote the construction of a strong manufacturing province in Zhejiang. Let national products enter the fast lane of policy dividends Take large-scale medical equipment as an example. For a long time, more than 80% of the medical equipment in the Chinese market has been occupied by foreign companies. After six or seven years of polishing, Mingfeng Medical, a private enterprise, has spent 1 billion yuan. It has repeatedly broken through the core technology of imaging medical system in scientific research, and has successively developed 16-row CT and 16-row PET-CT with independent intellectual property rights. Product performance It has reached the international first-class level and filled a number of domestic technological gaps. The technology is great and the products are great. However, what troubles Pan Huasu is that because it has not been tested by the market, many public hospitals can neither nor dare to buy their products easily, and still prefer more expensive imported medical equipment with average performance. The introduction of the new policy has brought opportunities for companies like Mingfeng Medical. The "Opinions" clearly stated that "the first set of equipment that meets

E-mail: sale@dermcosy.com

TEL：0086-533-2272875　

Address: No. 17, Nanzhi 1st Road, Zibo Science and Technology Industrial Park, Zhangdian District, Zibo, Shandong

鲁ICP备2021046616号-1

Shandong Dermcosy Medical Co.,Ltd.