two, How to apply for a Class III medical device business license/application agency

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.

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Shenzhen Business Co., Ltd. 1, Project name: Apply for the "Medical Device Business Enterprise License" II, Legal basis for setting and enforcing licenses:

1. "Regulations on the Supervision and Administration of Medical Devices"
2. "Measures for the Administration of Licenses for Medical Device Business Enterprises" III, TOLL: no four, Acceptance conditions(one)Have a quality management organization or full-time quality management personnel that is suitable for the business scale and scope of business.

Quality management personnel should have relevant professional academic qualifications or professional titles recognized by the state;(two)Have a relatively independent business location that is commensurate with the business scale and scope of business;(three)Have storage conditions suitable for the business scale and business scope, Including products that comply with the characteristics of medical devices

Require

storage facilities, equipment;(Four)A sound product quality management system should be established, including procurement, Incoming goods acceptance, Warehousing and storage, Warehouse review, Quality tracking and adverse event reporting system, etc.;(five)Should have technical training and after-sales service capabilities suitable for the medical device products it operates., Or agree to have a third party provide technical support;(six)Specific application conditions and

Require

Please refer to the "On-site Inspection and Acceptance Standards for Medical Device Operating Enterprises".

(seven)Operating sterile and implantable, Companies with interventional products need to establish computer management systems and computer management systems, Able to ensure effective quality tracking and traceability of products throughout the entire process from purchase to sale.. (eight)Enterprises operating in vitro diagnostic reagents must comply with the relevant regulations of the National Administration and

Require

Apply;Enterprises operating clinical testing and analysis instruments 6840 should indicate "(Does not contain in vitro diagnostic reagents)” words.

(Nine)Enterprises applying to establish branches, Application materials should be submitted in the name of the head office, At the same time, a power of attorney from the head office should also be submitted., Articles of Association, Stamped with the red seal of the head office and the business scope of the branch should not exceed the business scope of the head office.

five, List of materials submitted by the applicant(one)"Medical Device Operating Enterprise License Application Form" and "Medical Device Operating Enterprise Basic Information Form"(Including electronic version);(two)A copy of "Notice of Pre-approval of Enterprise Name" or "Industrial and Commercial Business License";(three) Articles of Association;(Four) The organizational structure and functions of the proposed enterprise(frame)picture;(five) List of employees in medical device operating companies, Product status table to be operated, Enterprise facilities and equipment status table(Filled out by the enterprise client and exported for printing)and certificates of academic qualifications and other relevant personnel of the proposed enterprise.;(six) Catalog of various quality management systems;(seven) Documentation supporting business and warehouse premises;(eight) Declaration of self-assurance regarding the authenticity of the materials provided.

six, for application materials

Require

(one)General application information

Require

:

1. The homepage should be the cover page of the application materials, Indicate the application matters, Company name, Application date and contact number;The next page is the application materials catalog, Indicate the content and page number of each part of the application materials in order.;Arrange and bind all materials into a volume according to the order stated in the application materials catalog.;There should be labeled spacers between each section of material., Indicate item number on label, The item number of this part of the material should be marked on the slip sheet., This content, Company name and application date;The entire set of information should be bound into a volume using A4 paper..
2. Application materials should be complete, clear, No alteration allowed.
3. Copies of application materials should be clear;
4. After application materials are accepted, Enterprises are not allowed to make supplementary applications on their own.
5. Copies of application materials are required, applicant(unit)The copy must be marked with the words "This copy is consistent with the original" or a text description, Indicate the date and attach the applicant’s signature or seal..
6. The product scope is filled in according to the first-level catalog of the "Medical Device Classification Catalog" published on the provincial bureau website;
7. Retail chain enterprise headquarters submits application materials, After passing the acceptance inspection and obtaining the operating enterprise license, Only its affiliated stores can submit application materials., And the business scope applied for shall not exceed the authorized business scope of the headquarters.;
8. Application materials in triplicate(Submit one copy to the provincial bureau, A city bureau record, a business record).

(two)specific information

Require

: 1, "Medical Device Operating Enterprise License Application Form" and "Medical Device Operating Enterprise Basic Information Form"(Including electronic version);(1)The application form can be obtained from the provincial bureau website(""Medical Device Business Enterprise License" Management System" → "Enterprise Client" → Download and fill in the form;(2)The medical device operating enterprise license application form is one of the important documents for enterprises to apply for the issuance of a business license., All contents in the form should be filled in completely, whole, precise, specific, and comply with the reporting

Require

, It should be signed by the legal representative or stamped with the official seal of the company.(If any);(3)Electronic version according to the provincial bureau website(2, A copy of the "Notice of Pre-approval of Enterprise Name" or "Industrial and Commercial Business License" and a copy issued by the administrative department of the provider must be clear., "Company name", The "registered address" must be the same as.

For newly established enterprises, provide a copy of the name approval notice. 3, The company's articles of association should be standardized, Comply with the "Company Law of the People's Republic of China", "Regulations of the People's Republic of China on Company Registration and Management" and other relevant provisions. Different companies have different styles of articles of association, According to their respective companies(unit)The situation provides specifications issued by the industrial and commercial administration department(Standard)Articles of Association;Branches need to provide articles of association of their head office;Individual industrial and commercial households do not need to provide.

When filling in the "Shareholders" column, please note that any unit or collective with legal person status that contributes capital should be filled in in the "Legal Person Shareholder" column., In other cases, fill in the "Natural Person" or "Natural Person Shareholder" column..

1. The organizational structure and functions of the proposed enterprise(frame)picture(1)Indicate the various internal organizations of the enterprise in the form of a simplified diagram(department);(2)Indicate each internal organization(department)functional elements, Functional content should be consistent with the business activities carried out and the actual situation of the company;(3)The establishment of the organizational structure should correspond to the company's articles of association and the proposed company employee positions., Set up various departments according to the actual situation of the enterprise, But it should at least include the general manager, Quality Management Department, Quality management group and quality acceptance group(Operating three categories of products), business(including procurement, Sales and after-sales service)department, office(Administration Department), warehousing(Tube)and other departments;(4)When filling in the electronic version of the information, the specific positions of all employees in the company should be clearly identified one by one., And correspond to the various departments under the organizational structure.
2. List of employees in medical device operating companies, Product status table to be operated, List of enterprise facilities and equipment and certificates of academic qualifications of relevant personnel of the proposed enterprise(1)Provide and fill in the enterprise employee status form and other forms (Fill out the report from the enterprise client);(2)Provide academic certificates that are consistent with the originals for all employees except the quality manager(diploma), job title(qualifications)Certificate and copy of ID card;(3)Basic information about quality managers(ID card, Copies of academic qualifications or professional title certificates and resume);(4)Proof or other proof of the termination of the labor relationship between the quality manager and quality inspector and the original unit(Original).

(5)

Require

Academic certificate of each employee(Professional title certificate), ID cards should be sorted together, for easy reference;If you are working in a hospital, Must provide proof of termination of labor relationship with the hospital;(6)In principle, the copies of academic qualifications or professional title certificates provided should be marked with a website address that can be directly queried and verified..

1. Product quality management system catalog(1)At a minimum, quality accountability systems including all levels should be provided, Expiry date product management system, Nonconforming product management system, Quality incident reporting system, Product Standard Management System, Product after-sales service system and product purchase, acceptance, Warehousing and storage, Warehouse review, Quality tracking and adverse event reporting systems;Companies operating sterile and implantable interventional products also need to develop computer management systems.

(2)The system formulated must conform to the actual situation of the enterprise itself.

1. Documentation supporting business and warehouse premises(1)Business operations and warehouse premises shall not be located in residential-type buildings.;(2)Provide proof of property including property(Own property)Or the lease agreement and the property certificate of the lessee and the local districted city housing management department or district(county)A copy of the "House Rental Certificate" issued by the private housing rental management office, And provide the company's geographical location map, Internal floor plan of operating and warehousing premises(Indicate the area and height of the business and warehouse premises, Label each internal department that corresponds to the organizational structure, Distribution status of warehouse "five areas");(3)If you have not applied for a property ownership certificate, Provide pre-sale license for commercial housing, Copy of commercial housing sales contract or construction project planning permit;Belonging to collective real estate, Provider(collective)Copy of the construction project planning permit held;(4)The specific address of the lease should be stated in the lease agreement, Floor, Room specific number and rental area, Lease term, Rent and other related content;(5)County level(Excluding county level)The following units or individuals do not need to provide a copy of the housing rental certificate.
2. Self-guarantee of the authenticity of the materials provided Declaration of the company's commitment to assume legal responsibility;Indicate the authenticity of the materials submitted, validity and legality;Stamp the official seal of the company;If it is a new enterprise, It must be signed by the legal representative or the person in charge of the enterprise..

seven, Licensing process(one) Acceptance of application materials that are incomplete or do not comply with statutory requirements

Require

of, The applicant should be notified on the spot or within 5 working days of all the content that needs to be supplemented and corrected.;Failure to notify after the due date, The application will be accepted from the date of receipt of the application materials..

(two) The person in charge of the review position shall review the application materials submitted by the applicant or the provincial, Conduct substantive review of the municipal bureau’s acceptance conclusion, According to the review, Put forward opinions and suggestions on whether to deny administrative permission or grant administrative permission respectively., Enter the review process. (three)Review The review opinions will be reviewed by the deputy director, Formulate opinions and suggestions on denying administrative permission or granting administrative permission, Enter review process.

(Four) Review Review and Review Opinions and Suggestions by the Director, Put forward opinions and suggestions on not granting administrative permission or granting administrative permission, Enter the approval process. (five) Approval based on review, Opinions or suggestions for review and review, Signed and approved by the director in charge. (six)Delivered by the Administrative Matters Reception Office.

eight, Processing time limit: An administrative licensing decision will be made within 30 working days from the issuance of the acceptance notice.(If necessary, it can be extended by 10 working days in accordance with the law.). Issued to the applicant within 10 days from the date of decision, Delivery permit.

Nine, Undertaken by the organization: Acceptance location: Note from the Administrative Matters Acceptance Department of the Provincial Food and Drug Administration: The provincial and municipal Food and Drug Administrations entrusted by the provincial bureau are responsible for accepting the approval and issuance of Class II medical device operating enterprises., Renewal and change application work. Apply for a medical device business license, 52Agency website to apply for medical device business license, 52Agency website to apply for medical device business license, 52 Daiban