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申请医疗器械经营许可证流程要求

申请医疗器械经营许可证流程

Require

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%。

申请医疗器械经营许可证流程

Require

进行说明:one、Have quality management organizations or quality management personnel that are commensurate with the business scope and scale of operations,Quality management personnel should have relevant professional academic qualifications or professional titles recognized by the state;two、Have operations that are commensurate with the business scope and scale of the business、storage place;three、Have storage conditions suitable for the business scope and scale,If all storage is entrusted to other medical device operating enterprises, there is no need to set up a warehouse.;Four、Have a quality management system suitable for the medical devices it operates;five、Have professional guidance appropriate to the medical devices being operated、Technical training and after-sales service capabilities,Or agree to provide technical support from relevant institutions;six、Have medical device operation quality management compliance

Require

computer information management system,Ensure the traceability of products sold。

申请医疗器械经营许可证流程

Require

One-stop service:Obtained medical device production and sales qualifications。You can also choose any service according to your needs。The above required information will be based on the actual products of the company、scale、There are big differences in business methods, etc.,If you need more information, please call the technical instructor.,We will provide one-on-one guidance and develop exclusive plans based on the actual situation of the company。

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