Qualification management

Qualification management


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1、 Network culture license

(1) What materials should be submitted in the application of network culture business culture license?
   1. Written application for network culture business license;
2. Notice of enterprise name pre-approval or business license and articles of Association;
3. The source, amount and credit certificate of the fund;
4. Company Profile: qualification certificate and identity certificate of the legal representative or principal person in charge, main management personnel and professional and technical personnel;
5. Certificate of the right to use the workplace;
6. Business development report;
7. Articles of association, ownership structure of the company and relevant information of shareholders;
8. Those engaged in Internet information services such as news, publishing, education, medical care, drugs and medical devices shall submit the examination and approval documents of relevant competent departments for pre approval;
9. Feasibility report and technical proposal for engaging in ICP business;The ability of providing long-term service for users and its safeguard measures, including follow-up fund guarantee, technical strength guarantee, commercial operation guarantee and built-in management mode;
10. Information security protection measures: including website security measures, information security and confidentiality management system, user information security management system;
11. Relevant materials proving the company's reputation;
12. The company's commitment to operating telecommunication business according to law;
13. Other documents required to be submitted according to law.

(2) what are the conditions for handling network culture business license?
  Anyone who is engaged in commercial Internet cultural activities within the territory of the people's Republic of China shall apply for the establishment of a profit-making Internet cultural unit.The establishment of a commercial Internet cultural unit shall comply with the relevant provisions of the measures for the administration of Internet information services and meet the following conditions:
1. Having the name, address, organization and articles of association of the unit;
2. There is a definite scope of Internet cultural activities;
3. Have a legal source channel of Internet cultural products or the production capacity of Internet cultural products;
4. There are business management personnel and professional technical personnel who meet the needs of Internet cultural activities and obtain the corresponding qualification;
5. Equipment, workplace and corresponding management technical measures to meet the needs of Internet cultural activities;
6. In line with the Ministry of culture's plan on the total amount, structure and layout of Internet cultural units;
7. According to the "several opinions on the introduction of foreign investment in the cultural field", foreign-invested Internet information service providers are not allowed to apply for Internet cultural activities, and service providers in Hong Kong and Macao are allowed to set up operational Internet cultural units controlled by the mainland;
8. Other conditions stipulated by laws and regulations.

(3) what is the application time and reply?
   For the application for the establishment of commercial Internet cultural units, the cultural administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the central government shall, within 20 working days from the date of accepting the application, submit the preliminary examination opinions to the Ministry of culture. The Ministry of culture shall make a decision of approval or disapproval within 20 working days from the date of receiving the preliminary examination opinions. If approved, it shall issue a network culture business license;If the application is not approved, the reasons shall be explained.


2、 Health food hygiene license

(1) What are the application conditions of health food hygiene license?
   To apply for health food hygiene license, the following application conditions shall be met:
1. Having the name, address, organization and articles of association of the unit;
2. Have a fixed office address, the registered address should be consistent with the office address, and the area should be more than 30 square meters;
3. The health certificate of at least two employees, which is issued by a hospital above grade three.
(2) What are the health food hygiene permit application materials?

1. Beijing health food (business) hygiene license application form;
2. One copy of business license;The newly established enterprise shall provide (copy of qualification certificate of legal representative or person in charge (resolution or appointment document of board of directors), copy of ID card and copy of pre approval certificate issued by industrial and commercial administrative department)
3. The use certificate of the business site (copy of house / land property right certificate or lease agreement);
4. Layout plan of business site;
5. Materials of enterprise health management organization and system, quality assurance system and relevant documents of quality control(Product certification system or first marketing system, and health management system of personnel and site);
6. One copy of health examination certificate of employees;
7. One training material of health food hygiene knowledge for employees;
8. Other materials deemed necessary by the food and drug administration;
9. Self assurance statement of the authenticity of the application materials, including the enterprise's commitment to bear legal liability in case of false materials;
10. If the applicant is not the legal representative or the person in charge when applying for the application materials, the enterprise shall submit the power of attorney.


3、 Road transport business license

(1) What are the procedures for applying for road transport business license?
   Step 1: apply.The applicant shall submit an application to the window of the Transportation Bureau of the county government service center, submit the relevant materials specified in the application conditions and fill in the application form;
Step 2: accept.After receiving the application, the Transportation Bureau window of the district government administrative service center shall complete the examination within 20 days from the date of accepting the application, and make a decision on whether to grant or not to grant the application.If permission is granted, a road transport operation license shall be issued to the applicant, and a vehicle operation license shall be issued to the vehicles put into transportation by the applicant;If the permission is not granted, the applicant shall be informed in writing and the reasons shall be given.If it should be submitted to the higher authorities according to law, an explanation shall be given to the applicant.

(2) What are the materials to be submitted in applying for road transport business license?
1. The following materials shall be submitted when applying for engaging in road transportation of ordinary goods:
   (1) Application form for road freight transportation operation;
(2) the text of the articles of Association;
(3) the identity certificate and its copy of the investor and the person in charge, the identity certificate of the operator and its copy and power of attorney;
(4) safety production management system text;
(5) letter of commitment for the proposed vehicles, including the number, type and grade, technical grade, number of seats, and the length, width and height of passenger cars.If the vehicles to be put into use belong to the purchased or existing ones, the driving license and vehicle technical grade certificate (vehicle technical test certificate) shall be provided;
(6) driver's license and professional qualification certificate of the employed or to be employed drivers and their copies

2. The following materials shall be submitted when applying for the operation of intercountry road passenger transport:
   ( 1) Application form for road passenger transport operation;
(2) the text of the articles of Association;
(3) the identity certificate and its copy of the investor and the person in charge, the identity certificate of the operator and its copy and power of attorney;
(4) safety production management system text;
(5) the driver's license and professional qualification certificate of the employed or to be employed drivers and their copies, and the certificate issued by the public security department that there is no major traffic liability accident within 3 years.

3. The following materials shall be provided when applying for the operation of road passenger transport lines at the same time:
   (1) Application form for operation of road passenger transport lines;
(2) feasibility report, including passenger flow status investigation, operation scheme, benefit analysis and possible impact on other relevant operators of the applied passenger line;
(3) station entry scheme.If a letter of intent for entering a station has been signed with the passenger station and the stop at the starting and ending points, the letter of intent shall be provided;
(4) transportation service quality commitment.

4. When applying for new passenger routes, the operators who have obtained the corresponding road bus passenger transport business license shall provide the following materials in addition to the materials specified in Item (2)
  (1) copy of road transportation business license;
(2) driver's license, professional qualification certificate and their copies of the driver to be employed, and the certificate issued by the public security department that there is no major traffic accident or above within 3 years;
(3) the identity certificate of the operator and its copy, and the work certificate or power of attorney of the unit to which he works.

5. For those who apply for the operation of road passenger lines at the same time of applying for business opening, the following materials shall also be provided in addition to the relevant materials for application:
   (1) Application form for operation of road passenger transport lines
(2) for the station entering scheme, if a letter of intent has been signed with the passenger station and the stop at the starting and ending points, the letter of intent shall be provided.
(3) transportation service quality commitment.

6. When applying for new passenger lines, the operators who have obtained the operation license of road bus passenger transport shall provide the following materials in addition to the above four materials:
   (1) And a copy of road transportation business license;
(2) copies of driving license and road transport certificate of the enterprise's own operating passenger car suitable for the type of passenger line applied for;
(3) letter of commitment for the vehicles to be invested, including the number, type and grade of passenger cars, technical grade, number of seats, and the overall length, width and height of buses.If the passenger cars to be put into use belong to the purchased or existing ones, the driving license, vehicle technical grade certificate (vehicle technical test certificate), bus grade evaluation certificate and their copies shall be provided;
(4) the motor vehicle driving license, employment qualification certificate and its copy of the driver to be employed, and the certificate issued by the public security department that there is no major traffic liability accident within 3 years;
(5) the identity certificate of the operator and its copy, and the work certificate or power of attorney of the unit to which he works.

7. Which of the following materials should be submitted by enterprises applying for road transport of dangerous goods?
  
(1) Application form for road transport of dangerous goods
(2) the type, category and operation scheme of the dangerous goods to be transported;
(3) the text of the articles of Association;
(4) the identity certificate and its copy of the investor and the person in charge, the identity certificate of the operator and its copy and power of attorney;
(5) the letter of commitment for the proposed vehicles, including the number, type, technical grade, communication equipment, total mass, approved load capacity, number of axles and the overall length, width and height of the vehicles, the tank volume of the special tank vehicle, the matching between the tank volume and the vehicle load mass, and the transportation of highly toxic, explosive, inflammable, etcSpecial vehicles for radioactive dangerous goods are equipped with traveling data recorder or positioning system.If the special vehicle to be put into use is purchased or existing, the driving license, vehicle technical grade certificate or vehicle technical test certificate, tank body inspection certificate or test report of special tank vehicle and its copies shall be provided;
(6) the qualification certificates and copies of the drivers, loading and unloading management personnel and escorts to be employed, and the driving licenses and copies of the drivers;

   (7) It has parking space and special parking area
And safety protection, environmental protection, fire-fighting facilities and equipment certification materials;
(8) relevant safety production management system text.

9. Enterprises applying for waterway cargo transportation shall submit the following materials:
   (1) Having transport vessels suitable for the business scope;
(2) a relatively stable source of tourists or goods;
(3) in the case of passenger transport, the stop (station) points along the passenger ship shall be determined and corresponding service facilities shall be provided;
(4) having an organization and person in charge of operation and management;
(5) it has its own working capital suitable for transportation business


4、 Radio and television program production license

(1) What are the application materials for radio and television program production license?
   1. Application report;
2. Articles of association of radio and television program production and operation organization;
3. Application form of radio and television program production and business license;
4. Main personnel materials:
(1) identity certificate (copy) and resume of the legal representative;
(2) resumes, achievements or certificates of major management personnel (not less than three) in radio and television and related majors, or certificates of having participated in relevant professional training.
5. Registered capital or capital verification certificate;
6. Office space certificate;
7. License of enterprise or institution or approval document of enterprise name issued by industrial and commercial administrative department.

(2) what are the conditions for the application of radio and television program production license?
   1. It shall have the status of an independent legal person and have the name, organization and articles of association in accordance with the laws and regulations of the state;
2. Having radio and television and relevant professionals, funds and workplaces suitable for the business scope, of which the registered capital of the enterprise shall not be less than 3 million yuan;
3. Three years before the date of application, the legal representative or organization has no record of revocation of the "radio and television program production and business license";
4. Other conditions stipulated by laws and administrative regulations

(3) what are the procedures for applying for the production license of radio and television programs?
   1. Acceptance: the applicant shall submit the application materials according to the catalogue of application materials, which shall be complete and conform to the legal form.
2. Examination: the application materials are complete and conform to the legal form, and the applicant meets the requirements of the legal administrative license.
3. Decision: the standard is the same as the examination standard.
4. Preparation and issuance verification, notification and delivery:

   (1) The application documents and their attachments shall be complete, standardized and effective; the legal documents shall be complete, correct and effective; the service documents and filing shall be timely, accurate and complete.
  (2) the notification shall be timely, accurate and comprehensive, and the statement and defense opinions of the applicant shall be heard.


5、 Environmental impact assessment qualification

There are two types of environmental protection permits according to their functions: one is to prevent environmental pollution, the other is to ensure the rational development and utilization of natural resources.
   First, what are the main types of environmental pollution prevention permits?
(1) discharge permit: it is stipulated in the detailed rules for the implementation of the law on the prevention and control of water pollution and the law on the prevention and control of air pollution.
(2) marine dumping permit: it is stipulated in the second paragraph of Article 55 of the marine environmental protection law and the regulations on the administration of marine dumping.
(3) permit for collection, storage and disposal of hazardous waste: it is stipulated in the law on prevention and control of environmental pollution by solid waste.
(4) waste import license: it is stipulated in the law on prevention and control of environmental pollution by solid waste.
(5) production, use and sales license of radioisotope and radiation devices: it is stipulated in the law on prevention and control of radioactive pollution.
Second, what are the main sources of environmental protection permits and their legal sources?
(1) forest cutting license: Forest Law
(2) fishery culture license and fishing license: Fisheries Law
(3) wildlife license, hunting license, domestication and breeding license: Wildlife Protection Law
(4) mining license: mineral resources law
(5) water resources exploitation license: water law


6、 Food and beverage qualification

(1) What are the application conditions?
   1. It shall have food raw material processing and food processing and storage places suitable for the variety and quantity of food to be produced and supplied, keep the environment clean and tidy, and keep the specified distance from toxic and harmful places and other pollution sources;
2. It shall have the business equipment or facilities suitable for the variety and quantity of the food to be produced and supplied, and the corresponding equipment or facilities for disinfection, changing clothes, washing hands, lighting, lighting, ventilation, refrigeration, dust prevention, fly prevention, rodent prevention, insect prevention, washing, waste water treatment and storage of garbage and waste materials;
3. Have food safety management personnel who have received food safety training and meet relevant conditions, as well as rules and regulations to ensure food safety that are suitable for the actual situation of the unit;
4. Have reasonable layout and processing flow to prevent cross contamination between food to be processed and directly imported food, raw materials and finished products Avoid eating There are poisons and unclean substances in contact with the products;

   5. Other conditions stipulated by the State Food and Drug Administration or the food and drug administration departments of provinces, autonomous regions and municipalities directly under the central government.
What are the application materials?
   1. Application form for catering service license;
2. The original and copy of the qualification certificate of the applicant, such as business license, notice of pre approval of name, legal person certificate of public institution or registration certificate of private non enterprise unit, etc;
3. The original and copy of the identity certificate of the legal representative, person in charge or the owner. If it is necessary to do it on behalf of the legal representative, person in charge or the owner, the original and copy of the power of attorney signed and confirmed by the legal representative, the person in charge or the owner and the identity certificate of the operator shall be supplemented;
4. The original and copy of legal use certificate of catering service site: including property right certificate, lease contract, construction land planning permit, construction land approval certificate, state owned land use certificate, etc. for places that cannot submit valid property right certificate, the operator can present the certificate of property right to the local people's government, sub district office, neighborhood (Village) committee, community workstation, etcThe park management committee (Industrial Park, science and Technology Park), market management unit, property management company, school and other units or departments shall issue the "place use certificate" that agrees to engage in catering service business activities in the place.
5. Schematic diagram and description of catering service business site and equipment layout, processing process, sanitary facilities, etc. (the sketch map shall indicate the name of the applicant, and indicate in detail the cooking, rough processing, cutting and matching, cleaning, pastry production, rough processing of stewed brine, salting of stewed brine, air drying of stewed brine, processing of raw seafood, cold dish production, cooked food salesThe area and size of flower mounting operation, food warehouse, food cooling, food packaging, food distribution, changing room, inspection room, dining and other places, and the specific location of facilities and equipment such as stoves, desks, cleaning pools, refrigerators, cold stores, disinfectors, air conditioners, containers, shelves, etc.);
6. Rules and regulations to ensure food safety, such as health management of employees, food safety training management, raw material purchase and inspection, ticket and certificate management, storage management, cleaning and disinfection management of tableware, etc;
7. Super large restaurants, large restaurants, school canteens, canteens of organs, enterprises and institutions with more than 500 people serving meals, headquarters of chain catering service enterprises, and group meal distribution units shall also provide key link food processing operation procedures, food safety inspection plan and emergency response plan for food safety emergencies;
8. To apply for the dessert station, the copy of the catering service license of the main restaurant, the distribution management system of the main restaurant, the food purchase inspection record system of the dessert station, and the sanitation management system of the environment, facilities and equipment of the dessert station shall be submitted;
9. To apply for herbal tea shop, the herbal tea raw material formula and declaration of not using toxic and harmful substances and drugs as raw materials of herbal tea shall also be submitted.For herbal tea shops that sell through centralized purchase and on-site sub packaging, the food production license or catering service license of the processing unit shall be provided;
10. Food safety management personnel training certification materials in accordance with relevant regulations.The following units must be equipped with senior catering service food safety administrators: super large restaurants (with an area of more than 3000 square meters), headquarters of chain operation catering service units, group meal distribution units, central kitchen, collective dining halls with more than 3000 people and catering service units undertaking reception tasks of major events.The following units shall be equipped with intermediate or senior food safety administrators: large restaurants, school canteens with less than 3000 people (including canteens of kindergartens), canteens of organs, enterprises and institutions with more than 500 people and less than 3000 people.Other catering service units should at least be equipped with food safety managers for primary catering services;
11. Description of food safety training of catering service employees and effective health examination certificate and copies;
12. Other materials required by laws, regulations, rules and normative documents or required by SFDA.

   ( 3) What is the application procedure?
   1. Application: the applicant shall submit an application to the "food and Drug Administration window" of the municipal administrative examination and approval service center.
2. Acceptance: if there are errors in the application materials provided by the applicant, he / she can point out the mistakes on the spot, and the errors that can be solved on the spot can be corrected on the spot;If the application materials provided by the applicant are not complete or do not conform to the legal form, the applicant shall be informed of all the contents to be supplemented and corrected on the spot, and a notice of supplement and correction materials shall be issued to the applicant;If the application materials are complete and conform to the legal form, or the applicant submits all the supplementary materials according to the requirements, it shall be accepted, and the acceptance decision of catering service license shall be issued.
3. Review: organize on-site review and acceptance in accordance with the "food service license review specification".
4. Decision: if it meets the standard through on-site examination, it shall make a decision to approve the administrative license;For those that do not meet the standards, the decision of not granting the administrative license shall be made and the reasons shall be explained in writing. At the same time, the applicant shall be informed of the right to apply for administrative reconsideration or to file an administrative lawsuit according to law.
5. License issuance: if the application materials submitted by the applicant and the on-site verification meet the legal conditions and standards, the decision to grant the administrative license shall be made, and the catering service license shall be issued within the legal time limit.


7、 Network culture license

(1) Network culture business culture license Which of the following materials should be submitted in the application?
   1. Written application for network culture business license;
2. Notice of enterprise name pre-approval or business license and articles of Association;
3. The source, amount and credit certificate of the fund;
4. Company Profile:
The qualification certificate and identity certificate of the legal representative or the main person in charge, the main business management personnel and professional and technical personnel;
  5. Certificate of the right to use the workplace;
6. Business development report;
7. Articles of association, ownership structure of the company and relevant information of shareholders;
8. Those engaged in Internet information services such as news, publishing, education, medical care, drugs and medical devices shall submit the examination and approval documents of relevant competent departments for pre approval;

   9. Feasibility report and technical proposal for engaging in ICP business;The ability of providing long-term service for users and its safeguard measures, including follow-up fund guarantee, technical strength guarantee, commercial operation guarantee and built-in management mode;
   10. Information security protection measures: including website security measures, information security and confidentiality management system, user information security management system;
11. Relevant materials proving the company's reputation;
12. The company's management of telecommunication business in accordance with the law The commitment of;
13. Other documents required to be submitted according to law

   (2) What are the conditions for applying for network culture business license?
  
Anyone who is engaged in commercial Internet cultural activities within the territory of the people's Republic of China shall apply for the establishment of a profit-making Internet cultural unit.The establishment of a commercial Internet cultural unit shall comply with the relevant provisions of the measures for the administration of Internet information services and meet the following conditions:
1. Having the name, address, organization and articles of association of the unit;

   2. There is a definite scope of Internet cultural activities;
3. Have a legal source channel of Internet cultural products or the production capacity of Internet cultural products;
4. There are business management personnel and professional technical personnel who meet the needs of Internet cultural activities and obtain the corresponding qualification;
5. Equipment, workplace and corresponding management technical measures to meet the needs of Internet cultural activities;

    6. In line with the Ministry of culture's plan on the total amount, structure and layout of Internet cultural units;
7. According to the "several opinions on the introduction of foreign investment in the cultural field", foreign-invested Internet information service providers are not allowed to apply for Internet cultural activities, and service providers in Hong Kong and Macao are allowed to set up operational Internet cultural units controlled by the mainland;
8. Other conditions stipulated by laws and regulations.

(3) application time and reply
   For the application for the establishment of commercial Internet cultural units, the cultural administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the central government shall, within 20 working days from the date of accepting the application, submit the preliminary examination opinions to the Ministry of culture. The Ministry of culture shall make a decision of approval or disapproval within 20 working days from the date of receiving the preliminary examination opinions. If approved, it shall issue a network culture business license;If the application is not approved, the reasons shall be explained.


8、 Medical device business license

(1) What are the conditions for the license application of medical device business enterprises?
Article 6 to apply for a medical device business enterprise license, the following conditions shall be met at the same time:
1. Having quality management institutions or full-time quality management personnel suitable for the business scale and business scope.The quality management personnel shall have relevant professional qualifications or professional titles recognized by the state;
2. It has a relatively independent business place suitable for the business scale and business scope;
3. Having storage conditions suitable for business scale and business scope, including storage facilities and equipment meeting the requirements of medical device product characteristics;
4. It is necessary to establish and improve the product quality management system, including purchase, purchase acceptance, storage, delivery review, quality tracking system and adverse event reporting system;   

       5. It shall have the ability of technical training and after-sales service suitable for the medical device products it operates, or agree that a third party shall provide technical support.

       Article 7 an application for a medical device business enterprise license must pass the inspection and acceptance of the (food) drug regulatory department.
The (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the central government shall, in accordance with these measures and in combination with the actual situation of their respective districts, formulate inspection and acceptance standards for medical device trading enterprises, and report them to the State Food and Drug Administration for the record.
Article 8 the business scope listed in the medical device business enterprise license shall be determined according to the management category and class code name specified in the classification catalogue of medical devices.
(2) What materials are required for the license of medical device business enterprises?
1. Application form for medical device business license;
2. Registration form of application materials for medical device business license;
3. A copy of the enterprise name pre-approval certificate or business license issued by the administrative department for Industry and commerce;
4. Copies of ID card, educational background or professional title certificate and resume of the person in charge of quality management of the proposed enterprise;
5. Copies of ID card, educational background or professional title certificate of the quality management personnel of the proposed enterprise;
6. Organization and functions of the proposed enterprise or functions of full-time quality management personnel;
7. The registered address of the proposed enterprise, the geographical location map of the warehouse address, the floor plan (indicating the area), the house property right certificate and the lease agreement;
8. Product quality management system documents, storage facilities and equipment catalogue of the proposed enterprise.
(3) What is the license application procedure for medical device business enterprises?

   Article 9 the (food) drug regulatory department of the province, autonomous region or municipality directly under the central government where the proposed enterprise is located or the entrusted municipal (food) drug regulatory agency divided into districts shall be responsible for accepting the application for issuing the license of medical device trading enterprise.
Article 10 the (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the central government or the entrusted municipal (food) drug supervision and administration institutions divided into districts shall publicize the conditions, procedures, time limit, catalogue of all materials to be submitted and demonstration text of the application form required for the application of the license of medical device trading enterprise on its administrative organ website or application acceptance site.
Article 11 when applying for the medical device business enterprise license, the following materials shall be submitted:

1. Application form for medical device business license;
2. Certificate of pre-approval of enterprise name issued by the administrative department for Industry and commerce;
3. Copies of ID card, educational background or professional title certificate and resume of the quality management personnel of the proposed enterprise;

4. Organization and functions of the proposed enterprise;
5. Copies of the geographical location map, floor plan (indicating the area) and the house property right certificate (or lease agreement) of the proposed enterprise's registered address and warehouse address;
6. Product quality management system documents, storage facilities and equipment catalogue of the proposed enterprise;

7. Business scope of the proposed enterprise.
Article 12 the applicant shall apply to the (food) drug regulatory department of the province, autonomous region or municipality directly under the central government where the proposed enterprise is located or to the entrusted municipal (food) drug regulatory agency divided into districts to apply for issuing the license of medical device trading enterprise.
The (food) drug regulatory department of the province, autonomous region or municipality directly under the central government or the entrusted municipal (food) drug regulatory agency shall handle the application according to the following conditions:
1. If the application items are not within the scope of the Department's functions and powers, it shall immediately make a decision not to accept the application, issue a "Notice of rejection" and inform the applicant to apply to the relevant department;2. If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to make corrections on the spot;
3. If the application materials are not complete or do not conform to the legal form, a notice of supplement and correction shall be issued to the applicant on the spot or within 5 working days to inform the applicant of all the contents to be supplemented and corrected at one time.If it fails to inform the applicant within the time limit, it shall be accepted as of the date of receiving the application materials;

4. If the application items fall within the scope of the Department's functions and powers, and the application materials are complete and conform to the legal form, or the applicant submits all the supplementary and corrected application materials as required, a notice of acceptance shall be issued《The acceptance notice shall be stamped with a special seal for acceptance and indicate the acceptance date.
   Article 13 the (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the central government or the entrusted municipal (food) drug supervision and administration institutions divided into districts shall, according to the inspection and acceptance standards for medical device trading enterprises, conduct on-site verification of the proposed enterprises, and review the application materials in accordance with these measures.
Article 14 the (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the central government shall make a decision on whether to issue the medical device business enterprise license within 30 working days from the date of acceptance.If it is considered to meet the requirements, it shall make a decision to approve and issue the medical device business enterprise license, and issue the medical device business enterprise license to the applicant within 10 days from the date of making the decision.If it considers that the requirements are not met, it shall notify the applicant in writing and explain the reasons, and at the same time inform the applicant that he has the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.

  Article 15 the food and drug regulatory department shall publicize the examination and approval process and results when examining the application of the applicant.The applicant and interested parties may submit written opinions on matters directly related to their major interests for statement and defense.
If the application for medical device business license directly involves the significant interest relationship between the applicant and others, the (food) drug regulatory department shall inform the applicant and the interested parties that they have the right to apply for hearing according to law.
If the food and drug regulatory department considers that the medical device business enterprise license involves public interests, it shall make an announcement to the public and hold a hearing.
Article 16 the (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the central government shall publicize the relevant information of the issued medical device business enterprise license, and the public has the right to inquire.

 


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