How to apply for a Shenzhen medical device operating enterprise license? What information needs to be submitted?

办理医疗器械经营许可证的条件和流程?深圳专业代办医疗器械经营许可证，欢迎有需要的您来电咨询业务。医疗器械经营许可证怎么办理?多年专业领域的成长，提供给你高品质的保证。

咨询顾问港信通-行政许可内容：

1. Review and issue the newly issued "Medical Device Business Enterprise License"(second、Class III medical devices)
2. Category 2、Class III medical device business enterprise merger、Legal basis for establishment of permission for division or transfer across original jurisdictions：
3. "Regulations on the Supervision and Administration of Medical Devices";
4. "Measures for the Administration of Licenses for Medical Device Business Enterprises" Specific Matters on Administrative Licensing Conditions：
5. Legal representative of the enterprise、Business person in charge、Quality management personnel should not have the circumstances specified in Article 40 of the "Regulations on the Supervision and Administration of Medical Devices";
6. The enterprise should have a quality management organization or full-time quality management personnel that is commensurate with its business scale and scope.;Quality management personnel should have relevant professional academic qualifications or professional titles recognized by the state，Professional and technical personnel who have been qualified in accordance with the law。

For example, the quality manager should be on-the-job，Not allowed to work part-time in other units

1. Have a relatively independent business location that is commensurate with the business scale and scope of business。
2. Have storage conditions suitable for the business scale and business scope(storage device、facility)。
3. Have technical training on operating products、After-sales service capabilities。
4. Should be based on relevant national and local regulations，Establish and improve the necessary quality management system，and strictly enforce。
5. National standards for medical devices should be collected and preserved、Industry standards and regulations on medical device supervision and management、Regulations and special provisions。
6. Passed the acceptance inspection in accordance with the "Implementation Standards for the Acceptance of Medical Device Business Enterprises in Guangdong Province"。申请人提交材料目录：Data number
7. "Medical Device Business Enterprise License Application Form"，"Medical Device Business Enterprise License"。

Data number

1. "Notice of Pre-approval of Enterprise Name" or "Industrial and Commercial Business License" issued by the industrial and commercial administration department。Data number
2. Application report。Data number
3. Business premises、Documentation proving the warehouse location，Include a copy of the property certificate or lease agreement and the lessor’s property certificate。Data number
4. Business premises、Warehouse layout plan。

Data number

1. Person in charge of formulating the law、Business person in charge、Quality manager’s ID card、Copy of academic certificate or professional title certificate and resume。Data number
2. List and academic qualifications of technical personnel、Copy of professional title certificate。Data number
3. Business quality management specification document directory。Data number
4. Enterprise installed product purchases、pin、stored information management system，Print the home page of the information management system。Data number
5. Warehousing Facility Equipment Catalog。

Data number

1. Quality management personnel’s on-the-job self-assurance statement and self-assurance statement on the authenticity of application materials，Including the catalog of application materials and the company's commitment to bear legal responsibility if the materials are false.;Data number
2. When applying for enterprise declaration materials，The person handling the matter is not the legal representative or person in charge himself，The enterprise should submit a "Power of Attorney"。

Data No. 13、Application for "Medical Device Business Enterprise License" confirmation letter for application materials

Require

：

1. The "Medical Device Business Enterprise License Application Form" submitted by the operating enterprise should be signed by the legal representative or stamped with the official seal of the enterprise.;
2. The items filled in the "Medical Device Business Enterprise License Application Form" should be filled in completely、precise，The content to be filled in should comply with the following

Require

。

A、"Company name"、The "registered address" is the same as the "Industrial and Commercial Business License" or "Notice of Pre-Approval of Enterprise Name"。B、The business scope to be applied for shall be filled in according to the first-level catalog of the "Medical Device Classification Catalog" issued by the State Food and Drug Administration in 2002.。C、"Registered Address"、When filling in the "warehouse address", the specific house number should be clearly stated.、Floor and room number。

1. Proof of identity of legal representative、Certificate of academic qualifications and professional title、The appointment document should be valid;
2. The copy of the "Notice of Pre-approval of Enterprise Name" or "Industrial and Commercial Business License" issued by the industrial and commercial administration department should be the same as the original，Copy to confirm and keep，Originals returned;
3. Property certificate、House rental certificate(The lessor must provide proof of property ownership)should be valid;
4. Business person in charge、Quality manager resume、Educational qualification certificate or professional title certificate should be valid;
5. Enterprises should establish medical device quality management files or forms based on their own actual conditions。
6. The self-guarantee statement on the authenticity of the application materials should be signed by the legal representative and stamped with the official seal of the company.，If there is no official seal，The signature or seal of the legal representative must be。
7. All application materials need to be submitted with copies，applicant(unit)The copy must be marked with the words "This copy is consistent with the original" or a text description，Date，Stamped with the official seal of the unit;Individual applications must be signed or stamped。
8. Application materials should be complete、clear、signature，And stamp each copy with the official seal，All application forms are typed and filled out by computer，Print on A4 paper，Use A4 paper for copying，Bind into a volume according to the order of the application materials catalog。

legal liability：

1. The applicant conceals relevant information or provides false materials to apply for the "Medical Device Business Enterprise License"，Province、autonomous region、municipality(food)The drug regulatory department or the districted municipality that accepts the entrustment(food)The drug regulatory agency will not accept the application or issue a "Medical Device Business Enterprise License"，and give warning。The applicant shall not apply for the "Medical Device Business Enterprise License" again within 1 year.。
2. The applicant deceived、Obtaining the "Medical Device Business Enterprise License" by improper means such as bribery，(food)The drug regulatory department should revoke its "Medical Device Business Enterprise License"，give warning，and a fine of not less than 10,000 yuan but not more than 20,000 yuan。The applicant shall not apply for the "Medical Device Business Enterprise License" again within 3 years.。

深圳商务有限公司咨询顾问港信通-地址：Related news：市食药监局召开医疗器械经营企业“五整五保”活动先行先试动员大会，300多家医疗器械经营企业代表、Counties(city、district)局主管领导和器械监管员参加了会议。

活动的具体内容是：开展无菌植入类专项整治，保证经营产品资质合法，Qualified quality;开展体外诊断试剂类专项整治，保证仓储管理严格，冷链运输安全;开展角膜接触镜类专项整治，保证购进渠道合法，验光专业

Require

落实;开展设备仪器类专项整治，保证质量责任明确，售后服务规范;开展计划生育类专项整治，保证购销记录和出入库验收正规齐全。

活动取得效果的几条标准。一是经营行为合法。经营主体合法，不存在无证经营、超范围经营和使用经营许可证过期行为。渠道合法，严格按照法律、regulations

Require

购进和销售产品，履行法定的义务。过程合法，按照质量管理规范的

Require

严把质量关，确保产品质量。二是经营产品安全。把好入口关，确保进入经营环节的产品质量合格。

把好贮存关，确保不因贮存管理不当导致产品出现问题。把好运输关，确保产品运输条件满足产品质量

Require

。三是经营企业正规。企业要严格按照医疗器械经营质量管理规范的

Require

，完善各项质量管理制度，健全质量管理机构，认真履行质量管理职责，建立规范现代的企业管理模式。四是经营秩序好转。

企业自觉树立合法经营意识、主体责任意识和产品质量意识，良性有序地开展竞争，营造守规则，讲诚信，遵秩序的市场环境。

About Hong Kong Xintong

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。