从近几年的国内外市场趋势来判断,不难看出从事医疗健康行业的市场潜力,但想要从事医疗器械相关经营必须要获得相关许可,而且由于医疗器械和个人的身体健康有很直接的关系,所以审批流程还是较为严格的。
医疗企业经营许可证一共有三类,其中办理一类医疗器械许可证可以直接办理,经营二类产品需要办理二类医疗器械经营备案凭证,经营三类产品则需办理医疗理医疗器械三类经营许可证
接下来,北京星期三企业管理可可给大家说说申请医疗器械三类经营许可证的流程及重点有哪些吧。
How long does it take to approve the registration of the class III medical device license? (1) Acceptance: The applicant shall apply to the Administrative Acceptance Service Center, submit the application materials in accordance with the catalogue listed in Article 6 of the Instructions, and the staff of the Acceptance Center shall examine the application materials in accordance with the requirements of the Acceptance Standards for the Registration and Application Materials of Domestic Third Class and Overseas Medical Devices (National Drug Administration [2005] No.111). Where the application item does not need to obtain an administrative license according to law, The applicant shall be informed immediately of the non-acceptance of the application; Where the application items do not fall within the scope of the functions and powers of the administrative organ according to law, A decision shall be made immediately, And inform the applicant to apply to the relevant administrative organ;