Conditions and procedures for applying for a medical device business license in Shenzhen

A medical device business license is a must-have document for medical device operating companies.，Establishing a second-category 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;Establishing a third-category medical device operating enterprise，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"。

Medical device business license is now post-approval，The industrial and commercial administration department shall apply for approval after issuing a business license.。The "Medical Device Business Enterprise License" is valid for 5 years。

Administrative licensing content

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"。Catalog number of materials submitted by the applicant
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.。Medical device license agency，Industry benchmark，trustworthy。

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