High-end medical device innovation encounters approval of "medium obstruction"
In order to promote the innovation of medical technology in China, the state has accelerated the reform of the examination and approval system for drugs and medical devices in recent years. However, the reporter recently found in an interview with a number of high-end medical device manufacturers that the problems of long product registration, unclear approval standards, tedious part of the links, and sluggish price review still exist. Registration and price approval “middle obstruction†led to the long-term clinical application cycle of some Medical Equipment new products and new technologies of some enterprises, which affected the competitiveness of domestic brands. Some enterprises were forced to abandon the domestic market to expand overseas markets, and some enterprises spent huge sums of money on research and development. It is difficult to transform technology into bankruptcy. High-end medical equipment is subject to approval for "middle obstruction" The long-term approval of drugs and medical devices is a major problem that plagues the medical industry . Many companies have told reporters that it is still common for high-end medical device new products to be registered in two or three years. A person in charge of a company said: "In recent years, the relevant departments have become stricter in the management of medical devices. This is a good thing, but the approval time is also increasing. A product of our company was registered in 2013 and was approved in the first half of 2014. The improved version of this product was declared in the second half of 2014, and has not yet received approval." The chief technology officer of another company said that high-end medical devices are mostly three types of medical devices, and the registration is approved by the relevant state departments. The number of products submitted for review in the country is numerous and the subject categories involved are complex, and the reviewers are very limited. I don't know, so I form an approval for the “block lakeâ€. "In 2015, one of our company's products expired, it is not a new product registration, it took more than a year. The sales of this product is 100 million yuan a year." In response to the problems reflected by the company, in 2014, the relevant departments formulated a special approval procedure for innovative medical devices, and opened a “green channel†for the promotion and application of new technologies. However, even with special approval, product registration is not always smooth. There are about 4.5 million heart failure patients in China, but only about 300 cases of heart transplant surgery in the year. In order to fill the gap of artificial heart in China, a western enterprise introduced foreign technology to develop artificial heart products. "At present, the artificial heart sells more than 1 million yuan in Japan and the United States, and can be reduced to more than 400,000 yuan after localization." The person in charge of the company is full of confidence in this project and obtained special approval qualification at the end of 2015. Originally thought that the product will be listed as scheduled, but due to the introduction of new domestic standards in the middle, product supplement testing is still waiting, more than a year has passed the clinical trial has not yet started, when the product is listed is even more difficult to predict. In addition to the lack of review power, the lack of clear approval criteria and the tedious part of the process are also important reasons for the lengthy registration approval. A person in charge of a company said that the new medical device technology could not be perfect, and the approval was not qualified. The reviewers were sometimes too demanding on the product risk, and often asked questions and could not get the legal policy basis. "We have a product in At the time of approval, he was asked to supplement the information more than ten times, and has not yet completed the approval. This product has only been supplemented once in the US FDA, and the registration has been completed in 8 months. It took only 3 months to get the EU approval." In accordance with relevant regulations, clinical trials of medical devices should be reviewed by the ethics committee of the testing organization. A person in charge of a company said that the hospital ethics committee usually meets once every two to six months. The experimental items for each review are limited. In order to improve the timeliness, some enterprises have to spend money and find relationships to go to public relations. Even if the company obtains the product registration certificate, it will face price review when it enters the hospital for clinical application. The medical services of non-profit medical institutions in China are subject to government-guided prices, and the charges for new medical device products must be applied from public hospitals to local price, health, and social security departments. "Because of the difference in price and medical insurance policy, the implementation of price audits varies from country to country. Every province and prefecture-level city has to do work. In most places, the price review of new products is seriously lagging behind, and it is almost necessary to run the enterprise to death." The person in charge of the interviewed company said. Interventional Accessories,Introducer Sheath Kit,Hydrophilic introducer sheath,PTFE coated guide wire,Y-Valve set Anesthesia Medical Co., Ltd. , https://www.medicaldiverse.com