Medical device registration and production separation research and development enterprises welcome good news

The new regulations on the supervision of medical devices have been implemented since this month, and the highlight of the regulations is to encourage research and development enterprises to innovate in the development of medical devices. Previously, enterprises had to apply for a production license and product registration certificate to launch a new product. Now, registration and production are separated, and research and development enterprises can obtain product registration certificates even if they do not have the ability to produce on their own. The entry threshold for enterprises has been greatly reduced, which brings unlimited motivation to product research and development, and related enterprises will also usher in more opportunities as a result.

Before the implementation of the new version of the Medical Device Regulatory Regulations, it is not enough to just have research and development capabilities to bring a product to the market. Relevant units also need to have strength, and obtain a production license before obtaining a product registration certificate. Obtaining a production license is not an easy task, as it requires building a factory, installing equipment, and complying with various relevant policies. This series of processes takes about five years to complete. Often, a domestically produced device has not yet been launched on the market, and similar foreign products have already been upgraded and replaced. Therefore, the slow development of domestically produced devices is not only due to a late start, but also largely related to the previous approval system. The demand in the market is constantly changing, and seizing opportunities is the key to gaining a competitive edge. Therefore, it is necessary to encourage research and development companies to promote the launch of new products as soon as possible.

After the implementation of the new regulations, any enterprise with research and development capabilities can obtain a product registration certificate, which allows more R&D enterprises without strong funds to also obtain a registration certificate. If they have solved the funding problem after developing new products, they can produce them themselves. Even if the problem is not solved, they can entrust other companies to produce. Some social capital, although not possessing R&D capabilities themselves, can cooperate with R&D institutions to become contract processing enterprises, gradually entering the medical device industry and promoting market development and growth.

The separation of registration and production undoubtedly benefits R&D enterprises, and medical device R&D institutions, especially small and medium-sized institutions, will be able to develop rapidly, benefiting the entire industry.