Accelerating the Construction of China's Medical Device Standard System

China's medical device standards system has been accelerated. Recently, the State Food and Drug Administration issued an announcement that 96 medical device industry standards such as "Hemodialysis Equipment" and "Single-use Disposable Syringe" have been approved and will be implemented on June 1, 2012. The reporter noted that the 96 standards include 34 mandatory industry standards and 62 recommended industry standards.

Analysts believe that for a long time, the problem of standardization has plagued the development of China's medical device industry. In particular, in the context of the new medical reform, domestic and foreign companies have joined forces in short-term and increased standards to enhance competitiveness have become the first choice for domestic companies.

"12th Five-Year" urging

In 2010, no one can deny that the new medical reform will have a positive effect on the medical and pharmaceutical industry. During the interview, people in the industry were sympathetic to this: Under the support of the new medical reform and the “Twelfth Five-Year Plan,” the people’s attitude toward health was more positive, and at the same time, the aging population in China put forward continuous demand for the medical and mechanical industry. In the next 10 years, 65 The proportion of the elderly above the age-old population has increased to nearly 12%. In addition, from 2002 to 2009, the compound annual growth rate of health care expenditure indicators for residents of households was over 11%. “It is precisely because of the combination of consumer upgrading, population aging, and technological revolution that has formed a concerted effort and has become an endogenous driving force for the long-term rapid growth of China's medical machinery market.” Tao Junchun, president of the Shenzhen Medical Device Industry Association, told reporters.

And 2011 is the first year of the “Twelfth Five-Year Plan”. The new medical reform is going deeper, and the medical and medical industry will also enter a golden period of rapid development. The "12th Five-Year Plan" of medical machinery is also in full swing. However, at the recent Nanchang Drug Fair, reporters discovered that many companies are feeling rejoicing and feeling pressure. "On the one hand, the medical and mechanical market gradually released tempting energy under the promotion of policies. On the other hand, the strong intervention of foreign medical and mechanical products is almost equal to the domestic brand cities," said the person in charge of a medical and mechanical company.

In fact, this is supported by the data disclosed by the National Center for Adverse Drug Reactions. The 1st issue of the 2011 Medical Device Adverse Event Information Bulletin released on January 4th this year showed that there were 487 suspicious medical device adverse event reports for only hemodialysis devices from 2002 to 2010. Among them, 313 were instrument failures, accounting for 64.27%. "With the current widespread use of hemodialysis therapy in the clinic, hemodialysis devices have also attracted attention. These include standards for hemodialysis equipment, non-electrically driven single-use portable infusion pumps, disposable syringes for single use, etc. Both will face severe upgrade challenges.” Tao Yuchun said.

“However, the key to the standard is implementation. It depends on whether the government has the determination to implement these standards. At present, not only the hemodialysis equipment industry, the entire medical machinery industry is relatively decentralized, the domestic product technology is relatively low, and the brand gap with foreign countries is too big. Big.” said Shajiang, a pharmaceutical industry analyst.

International pressure

It is understood that in 2010 the total size of China's medical machinery market exceeded the 100 billion yuan mark for the first time, and now it has leapt to the second place in the world, with high-end products accounting for 25% and low-end products accounting for 75%, especially disposable consumables. Wheelchairs, hygienic materials and medical dressings and other medium and low-end medical and medical products rank first in the world in output. If you simply look at the data seems optimistic, then the international medical device market, high-end products already accounted for 55% of the share, only 45% of low-end products. Comparing with the above data, it is not difficult to see that there is still much room for improvement in China's medical machinery market. However, this raises higher requirements for future medical and medical enterprises.

"If our medical products standards can be brought into line with international standards, the future market potential can be expected." Tao Yuchun told reporters that the standard upgrade is the main theme of industrial development. China's ethical standards still lag behind the advanced countries in the world. There are even many national standards that are blank. "Now that 96 new standards will be added will be a big improvement. Although this has little effect on large companies, most small businesses will need to make more efforts. Objectively, this will promote further concentration of industries."

However, he said: “The addition of 96 standards is certainly not enough, and some new national standards will be introduced in the future. Enterprises should get some kind of signal from them and actively raise the bar. We should participate in the development of international standards and from us Starting from its own special needs, establish its own standards and form a technical standard that restricts foreign products from driving straight into the market."

In fact, the medical machinery industry has begun to appear to be characterized by miniaturization, intelligence, and digitization. However, due to the lag in related standards, these products have caused many innovative medical and mechanical products to miss the market and added a few to the “going out” strategy. Blocking resistance.

Talking about this, Hu Junfei, the general manager of Zhejiang Lingyang Medical Devices Co., Ltd., is upset. "Now some innovative companies are faced with a kind of embarrassment: new product development has come out. Due to the lagging of relevant standards, new products are often roadblocked and long, and sometimes they can only sit and watch the market."

Sha Jiang also believes that the current domestic medical machinery products are mainly concentrated in the low-end, the introduction of new standards has only just begun, in the technical pursuit of transnational corporations without delay.

Long way ahead

During the interview, the reporter learned that during the “Eleventh Five-Year Plan” period, China initiated a new situation in the development of reference materials for the field of medical equipment, in particular for the development of reference materials for medical clinical laboratory and in vitro diagnostic systems. At present, there are more than 20 kinds of medical device standard materials being developed. In December 2009, the State Food and Drug Administration Medical Device Standards Management Center was established. At this point, China has issued 180 national medical device standards and 727 industry standards, covering 306 medical device products included in the medical device product catalog. With the addition of the 96 new industry standards that are now added, a standard system with a certain coverage has been initially formed.

"However, our current standards are still far from enough." Analysts pointed out that this "insufficiency" is manifested in two aspects. The first is the "quantity" aspect. China's medical industry standard is far less than the standard and refinement of foreign standards, and the gap in terms of quantity is disparity; followed by "quality" is not enough. Due to the non-standard medical device industry standards in China, standards in various regions are implemented in a variety of ways, and the level is still very low.

In view of this situation, Hu Junfei stated that, based on the existing standard system of veterinary medicine and improving the access threshold for enterprises, we must now strengthen the basic research on standard verification, test methods, and key indicators. To change the status quo of scattered, chaotic, and low medical machinery in China, the newly added 96 standards will pave the way for China's medical machinery industry to further advance toward the world.

“In this escalation battle, leading companies will benefit, and some small companies will be gradually cleared out of the market, increase industrial concentration and increase core competitiveness.” Sha Jiang believes.

The medical machinery industry has begun to appear to be characterized by miniaturization, intelligence, and digitization. However, due to the lag in related standards, these products have caused many innovative medical and mechanical products to miss the market and added a bit of blockage to the “going out” process. .