The new medical device supervision regulations have been implemented since this month. The biggest highlight of the regulations is to encourage the development of innovative medical devices for R & D companies. Before a company introduced a new product, it had to apply for a production license and a product registration certificate. R & D enterprises can obtain product registration certificates even if they do not have the ability to produce their own products. The barriers to entry for enterprises have been greatly reduced, which has brought unlimited power to product research and development, and related companies will usher in more opportunities.
Before the implementation of the new medical device supervision regulations, it is not enough to have a research and development capability to bring a product to the market. The relevant units must also have the strength to obtain a product registration certificate after obtaining a production license. Obtaining a production license is not easy. , Need to build factories, equipment, and also comply with the relevant national policies, and this series of processes to go down takes about five years, many times a domestic equipment has not yet been put on the market, foreign similar products have been upgraded With the replacement, the slow development of domestic equipment is not only because of the late start, but also has a lot to do with the previous approval system. The needs of the market are constantly changing. Seizing the opportunity can win the first opportunity. Therefore, R & D companies must be encouraged to promote new products to market as soon as possible.
After the implementation of the new regulations, as long as companies with research and development capabilities can obtain product registration certificates, this will allow more R & D companies without strong funds to obtain registration certificates. After they have developed new products, they can completely produce their products if the funding problem has been resolved. Even if the problem is not resolved, other companies can be commissioned to produce it. Although some social capital does not have R & D capabilities, it can cooperate with R & D institutions to become foundry processing enterprises, thereby gradually entering the medical device industry and promoting the development of the market.
Registration and production are separated. R & D companies are undoubtedly the biggest beneficiaries. Medical device R & D institutions, especially small and medium-sized institutions, will develop rapidly, and the entire industry will benefit as a result.
Copyright? 2014 Zhongguancun Medical Instrument Park Co., Ltd. All rights reserved. Beijing ICP No. 10216093 Address: 18th floor, Xingchuang Building, No. 6, West Jinxing Road, Daxing District, Beijing Contact: 010-53230088