Medical network - March 31, in order to promote medical technology innovation in our country, the country in recent years to speed up the implementation of medicines, medical equipment examination and approval system reform. But the reporter recently in an interview several high-end medical device manufacturing enterprise found that product registration time consuming, examination and approval standard is not clear, sometimes parts with such problems as lagging, price audit is still there. Registered, prices for examination and approval "obstruction" resulting in some companies of medical instrument new products, new technologies into the long cycle of clinical application of influence competitiveness of domestic brands, some businesses were forced to give up the domestic market to expand overseas markets, some companies costly research and development of technology is difficult to convert into bankruptcy. 

 

Obstruction in high-end medical equipment in examination and approval "" 

 

Medicines, medical apparatus and instruments for examination and approval of time-consuming, links is a problem in medical industry, many companies told reporters that the high-end medical equipment new products for two or three years to complete registration is still common. 

 

A company official said: "in recent years, relevant departments of medical equipment management has become increasingly strict, this is a good thing, but the approval time is increasing. My company's product declaration registered in 2013, examination and approval to complete the first half of 2014. But this product is improved from the second half of 2014 to declare, haven't got the approval." 

 

Another company's chief technology officer said, high-end medical equipment for three kinds of medical apparatus and instruments, registered by the national related department for examination and approval, the national department of product of the disciplines involved numerous and complicated, and review of personnel is very limited, don't know some of the new technology, forming "quake lakes" examination and approval. "In 2015, is a product of my company product expires, the renewal of museum pass is not new product registration, it took more than a year. The product sales is one hundred million yuan a year." 

 

Aiming at the problem of enterprise reflects, in 2014 the relevant departments to formulate innovative medical devices special approval procedures, an approval for the popularization and application of new technology "green channel". Yet even for special examination and approval, product registration is not smooth. 

 

Heart failure patients with about 4.5 million people in our country, but in heart transplant only about 300 cases, to fill the blank of the artificial heart in China and the west a company introduction of foreign technology products research and development of artificial heart. "The artificial heart in Japan, the United States for a set of more than 1 million yuan, after the localization can be reduced to 40, ten thousand yuan," the company chief confidence in this project, and got the certificate of special examination and approval at the end of 2015. Thought products will be listed on schedule, but due to the way of domestic new standard introduction, product testing is still waiting for, more than a year in the past the clinical trial has yet to start, when products listed is unpredictable. 

 

In addition to the lack of review and approval standard is not clear, sometimes parts is also registered for examination and approval of time-consuming long important reasons. A company director, said medical equipment new technology can't be perfect, and the eligibility of examination and approval and there are no clear standards, review staff on product risk too exacting, sometimes often ask questions can't get any legal policy basis, "we have asked to additional information when a product was approved ten times, is not yet complete, the examination and approval. And this product in the United States FDA added to only one data, eight months to complete the registration for examination and approval, to get the approval of the European Union in three months." 

 

In accordance with the relevant provisions, medical device clinical trials should be institutional ethics committee for review. A company director, said the hospital ethics committee meets once generally two to six months, every time the experimental project of review is limited, in order to improve the aging, some companies have to spend money, looking for a relationship to public relations. 

 

Even if the enterprise get the product registration certificate, in hospital is facing a price review in clinical application. Non-profit medical institutions in our country the government guidance price of medical services, and medical equipment fees of new products shall be at public hospitals, health and social security departments to apply for to local prices. "Everywhere because of differences in prices and health policy, price audit enforcement. Each province, city want to go to work, most local prices for new product review seriously lagging behind, enterprises run can be put to death dead tired", the head of the respondents said. 

 

Woe betide anyone who "innovation" 

 

High-end medical equipment in China started late, new technology, large investment, high risk, and foreign brand competition pressure, listed in time for the transformation of scientific and technological achievements, homebred brand preemption market is of great significance, which exist in the product registration and prices for examination and approval of "obstruction" of China's high-end medical equipment in the innovation and development of the companies surveyed said helplessly, director, woe betide anyone who "innovation". 

 

Controller introduces, the development of artificial heart enterprises domestic artificial heart is blank, the lack of technical standards and testing equipment, testing and clinical trial time-consuming, high cost of tens of millions of dollars, as a sino-foreign joint venture company, the company introduced foreign technology to obtain the clinical experiment and exemption has on the market in Europe and the United States, the company type Suggestions with reference to international practice for the introduction of mature technology breaks other countries have done test project. Domestic relevant experts recognized company advised, but not for examination and approval of relevant departments have been give you a definite reply, examination and approval progress has been slow. The company since its inception in 2014 has invested more than 8000 ten thousand yuan, currently facing foreign ready to interrupt the cooperation, the company is on the verge of bankruptcy. 

 

Long for examination and approval red tape, some enterprises have to give up the domestic market to expand overseas market. A responsible person of the enterprise, the company is currently selling more than 20 products, only 20% got the approval, registration and prices domestic overseas markets accounted for 60% share of the company. Even if already registered in the European Union and the United States regulators, want to be in domestic sales for clinical trials, still need to be while most foreign products don't have to. At the same time, special post in December 2015, the national development and reform commission to speed up to accept the new medical service price project, but more than a year passed, and still, in most parts of research and development of new products can only be shelved, greatly hurt the enthusiasm of scientific research personnel. "Medical market in China is very big, but" obstacle "let us into the domestic market for examination and approval of the difficulties, but to the foreign brands." 

 

We will accelerate reform of the examination and approval system to implement 

 

For registration, prices for examination and approval of "obstruction",, head of the respondents suggested that should speed up the implementation of the medical equipment examination and approval system reform, through domestic high-end medical equipment listed "the last kilometer". 

 

First of all, can use for reference the experience of the United States, the European Union management, pilot three kinds of medical equipment inspection, review, certification, and dredge registered backlog "quake lake". Respondents controller introduces, Europe and the United States the application for registration of a lot of the number of high-end medical equipment, but does not appear backlog problem because the product inspection to the marketization of professional institutions, enterprises can even self-inspection, and have very strict regulatory measures, once the fraud detection institutions and enterprises will face severe punishment. They suggest, may authorize the third party inspection institutions more types of medical equipment, technical approval can pilot down on the part of provinces and cities, and finally authenticated by the national related department to check. 

 

Once again, clear responsibilities for examination and approval of personnel, optimize the approval process. , head of the respondents suggested, should be further defined register for examination and approval conditions, standards, transparency, and the examination and approval authority and responsibility, examination and approval of personnel question should have a clear policy basis, limit the number of additional information, as long as the examination and approval of personnel is immune from liability in accordance with the relevant procedures for examination and approval, to avoid "who is who is in charge of examination and approval" for examination and approval of personnel enthusiasm; At the same time, the hospital ethics committee should safeguard the rights and interests of clinical subjects, mainly for the effectiveness of the three categories of medical devices clinical trials should be organized by the provincial administrative department of the expert evaluation. 

 

Third, accept the new medical service price review. Respondents, advice, head for the three types of medical equipment medical service price audit and whether directory into the health care, should be under centralized to the designated department, after the examination and approval of the department, various provinces and cities can be adjusted according to local conditions in a certain range after unification. In the long run, the government should also reform the medical service price pricing, gradually realize marketization.