Port communicationHow long does it take to apply for a medical device license in Shenzhen? If the preparation time and rectification time are not included, just the review time will take 45 working days, or one and a half months.，If the preparation time, rectification and re-audit time after rectification are calculated, it will be longer.，If technical ability is insufficient、Lack of thorough understanding of laws and regulations、Insufficient information preparation、The combination of factors such as incomplete rectification will greatly extend the period or even lead to failure of approval for up to one year.。
What usually happens is that companies still don’t know where the problem lies after failing the audit.，Or I don’t know how to rectify it, so I have gone through a lot of mistakes.，It consumes a lot of manpower, material resources and time costs。Class II medical device registration is issued on the same day，Class III medical device business license conditions will be issued 15 working days after submission of the conditions for review，But full refund!Ingenuity，Craftsman's heart。
Conditions for approval of Class III medical device business license 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。
How long does it take to apply for a medical device license in Shenzhen?
- 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。How long does it take to apply for a medical device license in Shenzhen?
- 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
。How long does it take to apply for a medical device license in Shenzhen?：The materials submitted for approval are not up to standard! The business address is not up to standard! There is no warehouse! The warehouse is unqualified! Worry without a professional quality manager!
please call us，A professional team will assist you throughout the entire process，Let your business be put into operation as soon as possible，Relieve your worries and worries! Shenzhen Gangxintong Co., Ltd. is a large-scale professional accounting agency, tax service and medical qualification processing institution with professional grades.，Since its establishment, the company has gathered a large number of professional、Rich time experience、Industry backbone with good communication skills and team spirit。
The company has high-quality customer resources，Plan the overall situation from a high starting point、Work to high standards、Promote development at a high level。Adhering to professionalism、Integrity、Efficient business philosophy to serve our customers，Achieve employees，Expand diversified business，Cultivate professional talents，Polish your professional brand，Strive and maintain a good reputation in the minds of customers and good evaluation in the industry，How long does it take to apply for a medical device license in Shenzhen? Strive to become a leading professional force。
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Hong Kong Xintong focuses onGuangdong and Hong Kong license plates、Shenzhen Hazardous Chemicals Business License、Shenzhen labor dispatch licenseandShenzhen Charity Foundationapplication services，Assist customers to applyShenzhen travel agency business license、Shenzhen pawn shop business license、Shenzhen auction house license and other mainstream domestic financial licenses，Support enterprises to achieve compliance expansion of cross-border financial business。Also availableODI overseas investment registration、International travel agency registration and other services，Help enterprises expand their presence in international markets。Provide one-stop compliance solutions for enterprises。To learn more，Please contactHong Kong Information Communications Consultant。
