关于广东省医疗器械注册人试点的思考

      Thoughts on Pilot of Medical Device Registrant in Guangdong Province

      • 摘要: 介绍了广东省医疗器械注册人试点工作的基本情况,通过分析已经获得试点批准的企业及产品的信息,归纳工作的成效及特点,指出目前存在的深圳企业占比大、惠及面不足、企业反应不积极等问题,分析了相关原因,包括替代制度的存在、知识产权保护、成本因素考虑、行业发展基础倾向于自建厂房等,提出完善工作的建议,包括加快立法、打造示范项目、提升监管能力等。

         

        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.

         

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