广州和深圳我公司都可以代办资质包括公司一起,只需要提供场地、人员资料即可,提供企业主的产品说明供我们撰写资料,人员方面也是根据产品来确定需要哪些类人员的,至少是从事医疗行业和相关学历的说明才可以,监管单位是需要到现场看场地的,而且需要面试的,所以还需要对企业负责人和质量管理进行一个面试前的培训,这样才可以顺利通过面试和看场地,对于拿到广州和深圳代办医疗器械公司资质是非常有利而且节省时间的。
广州和深圳代办医疗器械公司资质中的重点节点:
- Prepare information for application:Through the Guangdong Provincial Government Service Network,Search the name of the approval item "Medical Device Registration Approval",Select "Issuance of Class II Medical Device Registration Certificate"。Fill in the application information online,and upload relevant electronic documents。
- Acceptance of materials submitted on site:办理机关收到网上申请材料之日起5个工作日内确定是否受理,对行政相对人进行信用信息查询并实施联合奖惩。Application materials are incomplete or do not comply with legal forms,Notify the applicant of all the necessary supplements and corrections within five days,Failure to notify after the due date,The application will be accepted from the date of receipt of the application materials.。
- Waiting to get the processing result:申请人可登陆广东省食品药品监督管理局公众网首页审批查询栏进行办理进度查询,或登陆网上办事平台查询进度。Electronic certificates have been implemented for this matter,No additional paper certificates will be issued,Applicants can apply for certification themselves,You can also go to the provincial bureau acceptance hall with your digital certificate to print the certificate yourself.。
广州和深圳代办医疗器械公司资质的条件:
- The usable area of the business premises should be no less than 40 square meters,The usable area of the business premises of a branch of a legal entity shall be no less than 25 square meters.(Except for those set up across districts and cities);Dealer of hearing aids,The usable area of the business premises should not be less than 25 square meters;Those who deal in contact lenses and care solutions,The usable area of the business premises should not be less than 10 square meters。
- The usable area of the warehouse should be no less than 30 square meters;Dealing in disposable sterile medical equipment,The warehouse should be in the same building,The usable area should be no less than 200 square meters。
- quality manager、The person in charge of the quality organization should have a nationally recognized、Majors related to product management,College degree or above or intermediate technical title or above in related majors。
Dealing in disposable sterile medical equipment,还应当有一名以上持有医疗器械质量管理体系内审员正书的内审员等其他相关
Application conditions
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