Chinese medical device development time is short, the technical level is far behind the developed countries, a lot of products to be imported. In recent years, the amount and the number of imported medical devices has maintained sustained growth, particularly in high-end medical equipment and advanced its position in the Chinese market can not be replaced.
However, the level of the relevant regulatory seriously lagging behind, even though there are many problems for local medical supervision, to import medical supervision more difficult.
In all walks of life are regulatory problems, but as a high-tech medical equipment industry has high barriers in this respect, the industry involves many disciplines, is a multi-gate technology product highly integrated, experts and research institutes will be on staff Some medical equipment can not start, the regulatory staff is looking up regulatory objects.
Medical device regulation has been a problem, especially imports of medical device regulation difficult. China's medical equipment level is far behind the developed countries, the regulatory team is very limited understanding of advanced medical devices.
Lack of supervision led to the import of medical equipment unable to resolve security issues, bring more risks to the public safety, we urgently relevant departments to identify the appropriate regulatory measures to allow the import of medical equipment to better serve the people.