Port communicationNow operating three types of medical devices requires relevant certificates and licenses before operating.。Medical devices are divided into three categories，One of them can be handled directly，Class II medical devices need to be registered with relevant departments before they can be operated.，Class III medical devices must be reviewed by relevant departments and issued certificates before they can be operated.。Today I will explain to you how to apply for a Class III medical device license.。
Medical device agency is an industry that many people are flocking to，Of course, working as a medical device agent also requires you to meet certain conditions.。What are the conditions for being a medical device agent?，Conditions for medical device agents that should be met。
Process and price of agency medical device license
Require
：1、site
Require
：Office area plus storage area ≥ 160㎡ (if it is an in vitro diagnostic reagent type III medical device, it must have a cold storage，
Require
above 40m3)；2、personnel
Require
：3 relevant personnel are required to be registered and hold certificates；3、product
Require
：There must be product information that is consistent with the business scope，and issue a certificate；4、Other relevant laws and regulations
Require
。
Information required for agency medical device license process and price：
- Medical device operating enterprise license application form
- Pre-approval notice of enterprise name or industrial and commercial business license issued by the industrial and commercial administration department
- Documents supporting the business premises and warehouse premises include a property certificate or lease agreement and a copy of the lessor's property certificate；
- Business premises、Warehouse layout plan。
- A copy of the ID card of the legal person in charge, the person in charge of the quality manager of the enterprise, the academic certificate or professional title certificate and his/her resume
- Technical personnel search list and academic qualifications、Copy of professional title certificate；
- Business quality management specification document directory；
- Enterprise installed product purchases、pin、stored information management system，Print the home page of the information management system。
- Warehousing Facility Equipment Catalog；
- Apply for a confirmation letter of "Medical Device Business Enterprise License"。
Our main business：Medical device product registration consulting agent、Medical device production license、Medical device business license、Product registration and production registration for Class I medical device manufacturers、Product registration for Category II business enterprises、Licensing for Category Three Business Enterprises、In vitro diagnostic reagent registration、Imported medical device registration、Application for Internet Drug (Medical Device) Service Qualification Certificate、Consulting and guidance on clinical trials，Please contact me for the process and price of applying for a medical device license.。
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