Thoughts on Pilot of Medical Device Registrant in Guangdong Province / 中国医疗器械杂志

ABSTRACT

This article introduces the basic situation of the pilot medical devices registrant of Guangdong province, by analyzing the approval pilot enterprise and product information, results and characteristics of inductive work, points out many problems such as Shenzhen enterprises account for a large proportion, lack of benefits, response inactive, etc. analyzes the related reasons, including the existence of the alternative policies, the protection of intellectual property rights, cost factors, tend to increasee industry development foundation, etc., and puts forward suggestions for the perfect job, including speeding up legislation, building a demonstration project, improving regulation ability, etc.