Medical device license period and fees

Medical device license application cycle and

cost

The agency stated that because the growth rate of my country’s medical device market has been greater than the global growth rate in the past five years，As a result, my country’s share of medical devices in the world continues to rise，2012Year，my country's medical device market size is 221.9 billion yuan，Only accounts for 9.54% of the global share；And by 2025，my country's medical device market has accounted for more than 19%，more than tripled。

It is expected that the proportion of my country's medical device market will continue to increase in 2025，Reach more than 20%。

Medical device license application cycle and

cost

1. 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。
2. 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。
3. 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,There should also be more than one internal auditor holding a medical device quality management system internal auditor certificate and other relevant

Application conditions

。Our company has currently assisted thousands of medical device companies to register and sell，Good reputation from customers，As we all know, the reason why customers of medical device sales companies look for agents is simply because they don’t have a warehouse.，No registered address，and personnel。

Because you only open one，So you don't have much experience，And we are specialized in this industry，So we know every step inside.，If you want to open a medical device sales company, you can consult our company at any time.，Medical device license application cycle and

cost

You are more welcome to come to our company for negotiation，The purpose of our company is：a cooperation，lifelong friend。

Our purpose：Integrity management、Transparent charges、Pragmatic Service Our Goal：Let enterprises have no difficulty in obtaining medical device certificates. The content of this article is strictly prohibited from being reproduced by any website or individual.，Violators will be prosecuted。

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