Active export promotes medical device testing business upgrade

Business Club April 29th It is precisely because of optimistic about the development potential and export growth momentum of China's medical machinery industry, multinational medical and medical testing companies are constantly increasing their investment in China. With the advancement of the promotion of domestic medical and mechanical standards in recent years, the competition for future technical services has shown signs of technological upgrading.

Strong demand for testing services

On April 2nd, the opening ceremony of SGS Standards Technical Services Co., Ltd. (hereinafter referred to as SGS) Medical Device Service Department and Active Medical Device Laboratory was held in Guangzhou. The establishment of the laboratory aims to integrate and improve the testing service capabilities of SGS medical devices, and to create a one-stop green channel for domestic medical and mechanical enterprises to enter the international market, thus helping enterprises and their medical device products stand out in the international market competition.

Guan Junchao, Director of Medical Devices Services Department of SGS Group Zhonggang District, mentioned that the newly-established Medical Device Service Department has integrated SGS life sciences services, international certification services, light industrial product services, and active medical device services to greatly enhance its resources. The testing service capabilities of medical device products can provide medical device manufacturers in China and Hong Kong with more optimized and convenient services.

In the eyes of multinational medical and medical testing companies, as China's export of medical device products grows at a rate of 30% per year, high-end foreign companies have begun investing heavily in the research of medical device products in China. It can be predicted that the Chinese medical device industry will flourish.

Guan Junchao said that after SGS establishes the Medical Device Services Department and Active Medical Device Laboratory, it will comprehensively analyze the status of its own management and medical device products and market conditions, and provide one-stop solutions to help customers solve product design including medical devices. Various technical difficulties or confusions encountered during the production, packaging, sales, and export of products to the international market.

At the same time, TUV SÜD Group, another multinational medical apparatus company, has also stepped up its promotion efforts. Ms. Chen Zhaohui, Group Director of the Group's Medical and Health Services Greater China, said: “In recent years, the EU’s requirements for imported medical device products have become higher and higher. The qualifications of the certification body's professional resources have also made higher demands."

For transnational inspection companies that send technology to their home market, Zhao Yixin, president of the China Medical Device Industry Association, said that because some international standards for new medical products have not yet achieved international mutual recognition, exports of domestic enterprises have maintained rapid growth. The need for certification is still great.

When technical standards increase

In fact, the technical upgrading of domestic ethical standards and testing services has not stopped.

On March 3, the National Conference on the Implementation of the National Standard System for the Establishment of Medical Devices for Strategic Emerging Industries was held in Shenyang. During the meeting, the delegates seriously discussed the work progress and plans for the 2011 revision of the medical device standards, and decided to speed up the process of the revision of medical device standards for emerging industries.

On April 7th, director of the SFDA Shenyang Medical Device Quality Supervision and Inspection Center, Wang Lixin, told reporters that because of the rapid innovation in medical machinery products, the international standards are updated quickly, and domestic industries want to keep up with international standards, not only to strengthen product R&D, and to detect Institutions must also increase their technological level accordingly.

As Wang Lixin said, Zhao Yixin introduced to reporters that the current Medical Device Industry Association is also cooperating with the competent authorities to do some work on improving the device standards. In Zhao Yixin's opinion, the current domestic unified standard for medical equipment is still actively working, and promoting domestic medical instrument testing and certification, and promoting international certification integration and mutual recognition, is a continuous and progressive work.

It is precisely because of the overall consideration of continuously improving the level of medical and technical supervision that the State Food and Drug Administration has added the brand of the State Food and Drug Administration Medical Device Standards Management Center to the National Food and Drug Testing Institute in 2010. We will vigorously promote the improvement and innovation of medical device standards, establish and improve a medical device standard system, and promote the development of China's medical device industry.

Li Jun, general manager of the SFDA Medical Device Standards Management Center, explained to the reporter that the purpose of setting up the Medical Medical Standards Control Center is to improve the level of technical supervision and standards in China's medical machinery. Another key task of the Standardization Center is the emerging medical treatment. The technical supervision of the device product system is improved, and the organization of related scientific research and development is strengthened. The purpose is still to improve the overall level of Chinese phytochemical standards as soon as possible.