Port communicationMedical device business license application?Shenzhen professional agent medical device business license application/change，Customers are invited to come and understand。
In order to further standardize the behavior of medical device operating enterprises in the jurisdiction，Standardize the sales model of medical device business activities in the form of free trial，Crack down on exaggerating product efficacy、False propaganda and illegal business activities，The Food and Drug Administration has conducted supervision and inspection of medical device operating companies operating in an experiential manner within its jurisdiction，Focus on enterprise qualifications、Personnel qualifications、Venue and facilities、management system、Product qualification，Supervise and inspect promotional documents, etc.。
First, check the legality of operating enterprises and products。Check whether the operating enterprise holds a valid "Medical Device Business License" or "Medical Device Business Registration Certificate";Whether to operate medical device products beyond the scope;Product "Medical Device Registration Certificate" or "Registration Form"、Are the performance and scope of application recorded on the medical device instructions, labels, packaging labels, etc. consistent?。The second is to check whether there are exaggerations in the free trial site、False propaganda and other issues。
View experience venue postings、Distributed product promotional materials、personnel training materials、Are the learning materials distributed to experiencers consistent with the performance and scope of application stated in the product registration certificate? Is there any exaggeration of the product's efficacy?、False propaganda and other illegal advertising activities。First, check the legality of operating enterprises and products。
Check whether the operating enterprise holds a valid "Medical Device Business License" or "Medical Device Business Registration Certificate";Whether to operate medical device products beyond the scope;Product "Medical Device Registration Certificate" or "Registration Form"、Are the performance and scope of application recorded on the medical device instructions, labels, packaging labels, etc. consistent?。The second is to check whether there are exaggerations in the free trial site、False propaganda and other issues。
View experience venue postings、Distributed product promotional materials、personnel training materials、Are the learning materials distributed to experiencers consistent with the performance and scope of application stated in the product registration certificate? Is there any exaggeration of the product's efficacy?、False propaganda and other illegal advertising activities。Change of medical device business license?Shenzhen professional agent medical device business license application/change，Customers are invited to come and understand。
Event name application、The basis for approval of the renewal of the "Medical Device Business Enterprise License" is based on the "Regulations on the Supervision and Administration of Medical Devices" of the State Council.(State Council Order No. 276)Article 24、State Food and Drug Administration's "Measures for the Administration of Licenses for Medical Device Business Enterprises"(Bureau Order No. 15)and other relevant laws and regulations。Approval procedures are attached。
The review and approval time limit is 30 working days and the application form must be submitted.
Require
(one)"License" newly launched、Application materials for license renewal and other related administrative licensing matters must be bound into a book，Prepare page numbers and create a table of contents，One-to-one correspondence between page numbers and table of contents，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，Copies should be marked "Consistent with the original"，Corporate legal person’s signature, confirmation and seal。
(three)The "License" is valid for five years and expires，Need to continue operating，Medical device operating enterprises shall notify the company 6 months before the expiration date，Submit an application for certificate replacement in accordance with relevant regulations，The certificate renewal information is consistent with the newly established company information。(Four)Application form in triplicate，The remaining materials are in duplicate，and submit an electronic offer，Application filling software download：drug、Medical device operating enterprise license management system-enterprise client program。
New bid、Certificate replacement application information
Require
New bid、The time limit for certificate replacement is 30 working days，No charge。
Processing program download：Application procedure.(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"(triplicate)，Download address:Medical device operating enterprise license application form;(two)"Notice of Preliminary Approval of Enterprise Name" issued by the industrial and commercial administration department，The certificate renewal enterprise shall provide the original copy of the "Medical Device Business Enterprise License"，And provide a copy of the industrial and commercial business license;(three)Personnel information;1、ID card of the legal representative and person in charge of the enterprise、Hukou(a copy)Or relevant certificates and academic certificates issued by the public security organs、health certificate;2、ID card of enterprise quality management personnel、Copies of academic qualifications or professional and technical job certificates and personal resume、employment agreement、health certificate，Resignation certificate, etc.;3、Corporate 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)、Or a copy of the lease agreement with a lease term of more than 2 years，Lessor’s property ownership certificate，Residential housing、The community is not allowed to be used as an office、storehouse。
(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。(eight)Information authenticity statement，Enterprises applying for certificate renewal must declare the authenticity of the materials submitted。Declaration format download：Statement of authenticity.
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