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Registration process for Class II medical device qualifications in Shenzhen and Guangzhou

Why choose Hong Kong Xintong to apply for a medical device business license? because,First of all, we are applying for qualifications with real materials! You can check it at the Food and Drug Administration in Shenzhen and Guangzhou.。Secondly,When we negotiate with our customers, we will advise them on the location of their business.。After signing the contract, according to national policies,We will design and layout offices and warehouses,Preparation of application materials and on-site acceptance materials throughout the process。We dare to promise to pass the on-site acceptance in one go。

It is these precise work contents that ensure that customers can quickly obtain qualifications。

first stage:Apply:The drug regulatory department checks whether the application materials comply with the basic

Require

,Decision on whether to accept or reject an application;(The application process requires filling in nearly a hundred pieces of information.,If the person accepting the application finds any problem with filling in the information, he/she needs to return it for correction.,If major non-conformities are found, the application will be rejected directly) The second stage:on-site review:That is, the drug regulatory department assigns one to three auditors to conduct audits at the business site.,The review method is on-site questioning and assessment and on-site inspection and assessment.,Record audit information truthfully and give audit conclusions,If it does not match

Require

Can

Require

The enterprise shall make rectifications until the rectifications comply with

Require

,If you are not satisfied after rectification,

Require

giving notice of disapproval;(The purpose of the review is to:Review the legality of business operations、conformity and authenticity,If it is found that the laws and regulations are not followed、rules and regulations implemented,The conclusion of the review will directly affect whether it can pass the review.,Or affect whether the enterprise can obtain the business license qualification) The third stage:review、public announcement、correct:That is, after the leaders of the drug regulatory department review and approve relevant information, they will decide whether to issue a business license to the enterprise.,If the company passes the review, its company-related information will be publicized on relevant websites.,If there is no objection to the announcement, the company will be notified to obtain a formal medical device business license.。

(consistency、legality、Compliance is the key - provided by Hong Kong Information Communication) Note:If there is a problem or rejection in any of the above steps, all previous work will need to be started from scratch.,Therefore, attention should be paid to every aspect to achieve better results。Therefore, you should be extra careful when applying,during actual operation,Many friends underestimate the difficulty of the application and think that they can get through it casually.,Very simple and easy!

Shenzhen Gangxintong International Business Co., Ltd. is a professional medical device consulting organization,Focus on providing all over the country such as:Shenzhen、Guangzhou、dongguan、Zhongshan、foshan、Zhuhai、Huizhou、Shunde、Technical consulting services in the field of medical devices in well-known cities such as。Hong Kong Xintong International specializes in medical device processing in Guangdong.、Add items、change、Cancellation and other medical device related services。Any online or personal reproduction of this article is strictly prohibited,Violators will be prosecuted。


About Hong Kong Xintong

Hong Kong Xintong focuses onGuangdong and Hong Kong license platesShenzhen Hazardous Chemicals Business LicenseShenzhen labor dispatch licenseandShenzhen Charity Foundationapplication services,Assist customers to applyShenzhen travel agency business licenseShenzhen 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

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