How to apply for a Shenzhen medical device operating enterprise license? What are the conditions and steps?

New method for applying for license for medical device business enterprises in Shenzhen?Shenzhen professional medical device field services，Professional provision of medical device business license application services，10Years of agency experience，Experienced team at your service，Medical device business license application，Shenzhen is more professional。

Company Name：Consulting company address：怎样办理《医疗器械经营企业许可证》?A medical device business license is a must-have document for medical device operating companies.，Start a first-class medical device operating enterprise，should report to the province、autonomous region、Registration with the Drug Supervision and Administration Department of the People's Government of the Municipality directly under the Central Government;Open a second category、Category III medical device operating enterprises，Should reflect on、autonomous region、Review and approval by the drug regulatory department of the municipal people’s government，And issued a "Medical Device Business Enterprise License"。

Without a "Medical Device Business Enterprise License"，The industrial and commercial administration department shall not issue business licenses。The "Medical Device Business Enterprise License" is valid for 5 years。

Tools/Materials：(one)A report on applying for the establishment of a medical device operating enterprise，Fill out or print the "Medical Device Business Enterprise License Application Form"(Quadruplicate);(two)"Notice of Preliminary Approval of Enterprise Name" issued by the industrial and commercial administration department;(three)Personnel information;1)、ID card of the intended legal representative and person in charge of the enterprise、Household register or relevant certificates issued by the public security agency and academic certificates、health certificate;2)、ID card of the quality management personnel of the proposed enterprise、Copies of academic qualifications or professional and technical job certificates and personal resume、employment agreement、health certificate;3)、Proposed enterprise personnel roster，and health certificate。

The roster includes：Name，gender，age，Professional and technical positions/academic qualifications，Position/Position。(Four)The organizational structure and functions of the proposed enterprise;Enterprise develops organizational chart，Clearly identify the division of labor within the enterprise，and the position and functions of company personnel。(five)Proposed business registration address、Geographical location map of warehouse address、floor plan(Indicate area)、House ownership certificate(or lease agreement)a copy。

(six)Proposed enterprise product quality management system documents and storage facilities、Device catalog;(seven)Catalog of business categories to be established;The catalog includes the following：Product name、factory、Specification、Registration number，and corresponding product storage conditions、

Require

description。Steps/Methods：

1. Submit application materials to the Provincial Food and Drug Administration or Municipal Food and Drug Administration，Conduct formal review;
2. Formal review has two results。

1)、Project acceptance 2)、Not accepted;

1. After passing the form review，Administrative review and technical review will be conducted(Includes expert review、On-site acceptance);
2. After both administrative review and technical review are passed,，Certificate preparation will be carried out;
3. Finally, wait for notification to collect the certificate at the acceptance office.。

Things to note

：(one)"License" newly launched、change、Application materials for license renewal and other related administrative licensing matters must be bound into a book，Page numbering，Develop catalog，Easy to read、tidy。(two)All application materials must be made in A4 format.，Should be printed or filled out clearly and neatly，Binding specifications。

To apply for a Shenzhen medical device operating enterprise license, go to Shenzhen，One to one service，Complete online processing，One-stop entrepreneurial platform;Shenzhen Medical Device Business Enterprise License，Customer service has served hundreds of companies，Offer free，No money will be charged if unsuccessful，Safe and guaranteed。

Medical device operating enterprise license application conditions and procedures?How much money is needed?Are there any discounts for licensing??Is the application form for a medical device operating enterprise license complicated??How long does it usually take to get it done??Company Name：Consulting company address：其他业务服务：Human Resources License、Labor dispatch license、Medical device license、Property qualification license、Dangerous goods business license、Health product business license、health license、road transport license、Security service company license、Refined oil business license、ICP business license、Express business company registration、Shenzhen training institution established

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