Please refer to the application requirements of Nanjing Class III medical device business license.
First, the basis for handling
1, Administrative Licensing Law of People's Republic of China (PRC);
2. Regulations on the Supervision and Administration of Medical Devices (promulgated by Decree No.650th of the State Council of the People's Republic of China);
3. Measures for the Supervision and Administration of Medical Device Operation (Order No.8 of the State Food and Drug Administration of the United States);
4. Notice of the General Administration of Food and Drug Administration of the United States on Implementing the Measures for the Supervision and Administration of Medical Device Production and the Measures for the Supervision and Administration of Medical Device Operation (Food and Drug Administration 143 [2065438]No.);
5. Notice on Implementing the Measures for the Supervision and Administration of Medical Device Production and the Measures for the Supervision and Administration of Medical Device Operation (No.2014);
6. Notice on Printing and Distributing the Acceptance Criteria of Medical Device Business License in Jiangsu Province (Su 1 [2065438]No.);
Second, the applicant's qualifications
All kinds of enterprises with business licenses and organization code certificates. The personnel who apply for the business license of Class III medical devices shall be entrusted by the applicant and be familiar with the requirements of relevant laws, regulations and rules and the matters to be handled.
Third, the application conditions
The third kind of medical equipment wholesale
(a) the person in charge of the enterprise shall be familiar with the laws and regulations on the supervision and administration of medical devices and the relevant knowledge of the medical devices it operates, and have no record of the acts mentioned in Articles 64 and 65 of the Regulations on the Supervision and Administration of Medical Devices. The person in charge of the enterprise engaged in in in vitro diagnostic reagents and plastic contact lenses should have a college degree or above.
(2) The enterprise can designate a top manager as the person in charge of quality to be responsible for the overall quality management of the enterprise. The person in charge of an enterprise cannot concurrently be the person in charge of quality.
(3) An enterprise shall set up a quality management organization (consisting of at least three persons, including the person in charge of the quality management organization). The person in charge of the enterprise shall not concurrently be the person in charge of the quality management organization and the quality controller.
(4) The person in charge of enterprise quality and the person in charge of quality management organization shall exercise their respective quality management functions according to the written authorization, and exercise the power of medical device quality adjudication within the enterprise scope according to the authorization.
(five) the enterprise should set up or be equipped with departments such as acceptance and maintenance of medical devices that are suitable for the scale and variety of operation. Acceptance and maintenance departments should be subordinate to or accept the supervision and guidance of quality management institutions in business.
(6) An enterprise shall set up technical training and after-sales service departments/personnel suitable for its business scale and business variety, or agree to provide technical support by a third party.
(7) The person in charge of quality should have a college degree or above in medical devices or related majors or a junior technical title or above in related majors recognized by the state (related majors refer to mechanical, electronic, medical, pharmaceutical, bioengineering, chemistry, nursing, computer and other science, engineering, agriculture, medicine and pharmacy majors, the same below). The person in charge of quality should be familiar with the laws and regulations on the supervision and management of medical devices and the relevant knowledge of the medical devices handled, and have certain practical experience.
In an in-vitro diagnostic reagent business enterprise, the person in charge of quality should have a bachelor degree or above and an intermediate title or above in related majors (laboratory science, microbiology, medicine, pharmacy, biochemistry, etc.). , the same below), familiar with relevant laws, regulations and rules, with more than 5 years working experience in in vitro diagnostic reagents.
(eight) the person in charge of the quality management institution shall have a bachelor's degree or above in medical devices or related majors or a nationally recognized intermediate or above technical title in related majors, and have more than 2 years' experience in medical devices.
The person in charge of an in vitro diagnostic reagent business enterprise or quality management institution shall have a bachelor degree or above and an intermediate title or above in related majors (laboratory science, microbiology, medicine, pharmacy, biochemistry, etc.). , the same below), familiar with relevant laws, regulations and rules, with more than 5 years working experience in in vitro diagnostic reagents;
(nine) the person in charge of quality and the person in charge of the enterprise quality management institution shall be on the job, and shall not work part-time in other units, and there is no record of serious violation of laws and regulations on medical devices.
(ten) the person in charge of quality and the person in charge of the quality management institution shall receive on-the-job training, and can only take up their posts after passing the examination.
(eleven) the person who exceeds the statutory retirement age of the state is the person in charge of the quality management institution of the enterprise, and the age is not more than 68 years old, and provides the medical certificate issued by the medical institution above the second level in Nanjing.
(12) To apply for the operation of implantable products, two medical professionals with bachelor's degree or above who have been trained by manufacturing enterprises or suppliers shall be provided, and they are on-the-job personnel, and shall not work part-time in other units. Persons over the statutory retirement age of the country shall undertake this work, and the age shall not exceed 65 years old, and provide medical certificates issued by medical institutions at or above the second level in Nanjing. The person in charge of the enterprise and the quality management personnel shall not concurrently serve as the medical technicians referred to in this article.
Plastic contact lens business enterprises should have technical service personnel of ophthalmology related majors.
(thirteen) personnel engaged in specific quality management, inspection and maintenance, measurement and other work, should have a high school or technical secondary school education, after relevant training and assessment of qualified posts. Personnel with employment access positions in the country must pass vocational skills appraisal and obtain valid vocational qualification certificates before they can take up their posts.
In an in vitro diagnostic reagent business enterprise, the personnel engaged in specific quality management, acceptance and after-sales service shall have a technical secondary school degree or above in related majors; Maintenance, sales and other personnel should have a high school or technical secondary school education. Quality management, acceptance, maintenance, sales and after-sales service personnel should receive pre-job training, and they can only take up their posts after passing the examination.
(fourteen) personnel engaged in quality management, acceptance, storage, sales and other direct contact with medical devices and products shall conduct a health examination every year and establish files. Persons suffering from infectious diseases or mental illness shall not engage in direct contact with medical devices and products.
(15) The registered capital of the enterprise shall not be less than RMB1100,000 yuan. After the business scope exceeds 8 categories, the registered capital will be increased by 500,000 yuan for every 65,438+0 category. When applying for a medical device business license, a medical device manufacturing enterprise shall independently set up production and business personnel, business premises, warehouses, equipment and facilities with a total registered capital of not less than 5 million yuan.
The registered capital of an enterprise dealing in in-vitro diagnostic reagents is not less than 3 million yuan.
(sixteen) the business premises should be relatively independent, and adapt to its business scale and business scope. Business premises shall not be located in residential buildings, military camps (excluding leasable areas) and other places that are not suitable for business operation. The business premises must be clean, bright and hygienic. The area of business premises for medical devices of Class III, which are of Class 8 or below, shall not be less than 100 square meters (excluding warehouses, it shall be calculated according to the construction area with property right certificate, and the use area of those without property right certificate shall be calculated according to × 1.2, the same below); The area of business premises above 8 categories shall not be less than 200 square meters.
In vitro diagnostic reagents business enterprises, business premises area of not less than 200 square meters.
(eighteen) the enterprise shall set up a product showroom or product showcase to display the products operated by the enterprise. If the business products are not suitable for display, the pictures of the business products shall be hung in the business premises, and the product introduction materials shall be prepared.
(nineteen) enterprises should have warehouses that are suitable for the scale, scope and variety of operations, and warehouses should not be located in residential buildings, military camps (excluding leasable areas) and other places that are not suitable for setting up warehouses. Warehouse location should take into account the principles of convenient management and nearby operation. Class III medical devices of class 8 and below, where the warehouse address is the same as or adjacent to the business premises (the same or adjacent house number, the same below), the warehouse area shall not be less than 50 square meters (including cold storage, the same below); Where the warehouse address is different from the business premises, the warehouse area shall not be less than 80 square meters (not less than 20 square meters with auxiliary business premises); If there are more than 8 types of business, the warehouse address is the same as or adjacent to the business premises, and the warehouse area shall not be less than 80 square meters; Where the warehouse address is different from the business premises, the warehouse area shall not be less than 150 square meters (the affiliated business premises shall not be less than 20 square meters). Products that need to be stored in a cool place should be equipped with a cool warehouse of not less than 20 square meters; Products with refrigeration requirements shall be equipped with refrigeration facilities not less than 10 cubic meter. Products that need to be stored under special conditions should have corresponding storage conditions.
If the warehouse address of an enterprise engaged in in in-vitro diagnostic reagents is the same as or adjacent to the business premises (the house number is the same or adjacent), the total warehouse area shall not be less than 100 square meter; Where the warehouse address is inconsistent with the business premises, the total area of the warehouse shall not be less than 150 square meters (the affiliated business premises shall not be less than 20 square meters). The warehouse should be equipped with a cool warehouse of not less than 20 square meters; Cold storage should be set up, its volume should be adapted to the scale of operation, and the volume of cold storage should be not less than 20 cubic meters.
(twenty) the temperature and capacity of the warehouse should be set to adapt to the variety and scale of operation. The room temperature is 0-30℃, the cool room temperature is 0-20℃, and the cold storage (cabinet) temperature is 2- 10℃. The warehouse temperature of special products is set according to the requirements of product specifications. The relative humidity of normal temperature storage and cold storage is 40-80%. The humidity of special products should be set according to the requirements of product specifications.
(twenty-one) there should be no weeds and pollution around the reservoir area; The loading and unloading place should have a ceiling; The warehouse should be clean and sanitary, with tight doors and windows, flat ground and complete facilities, with corresponding floor mats, shelves, temperature and humidity control equipment and temperature and humidity measuring instruments, and facilities such as light protection, insect prevention, rat prevention, mildew prevention, pollution prevention, moisture prevention, ventilation, lighting and fire prevention.
If in vitro diagnostic reagents are operated, the warehouse should also be equipped with effective automatic control and temperature and humidity detection equipment; Cold storage should be equipped with automatic monitoring, control, display, recording temperature status and automatic alarm equipment, as well as standby generator sets or installation of two-way circuits and standby refrigeration units; Set up storage places for packaging materials and equip them with corresponding equipment.
(twenty-two) the warehouse should be clearly marked, respectively, set up to be inspected (warehouse) area, delivery (warehouse) area, qualified warehouse (area), unqualified warehouse (area), return warehouse (area). The warehouse shall be managed by color code, and the qualified area and delivery area shall be green, the unqualified area shall be red and the waiting area and return area shall be yellow. Product stacking should have obvious signs and location tags, and there should be a certain distance between stacks, stacks walls and stacks tops.
(twenty-three) enterprises engaged in in in vitro diagnostic reagents should have transportation facilities and equipment (such as refrigerated trucks, car refrigerators, etc.). ) to adapt to the business scale and variety, and meet the requirements of storage temperature of in vitro diagnostic reagents. Enterprises should be equipped with at least two 40L car refrigerators (the maximum range is minus 18 degrees), and equipped with devices or instruments that can monitor the temperature during transportation in real time.
(twenty-four) the business of implantable products and plastic contact lenses shall have the ability and conditions to record and track the first dealer or user for a long time through unique labels such as bar codes. Orthokeratology mirror business enterprises shall work out the "Letter of Responsibility for the Use of Orthokeratology Glasses" with the production unit, affix the seal of the unit, and provide it to the fitting agency with the products.
(25) An enterprise shall be equipped with computer equipment and management software suitable for its business scale, which can realize the computer data association with the local food and drug supervision department, upload relevant data such as purchase, sales and storage in time, and have the conditions to accept the supervision and management of the local food and drug supervision department through the remote supervision platform.
(twenty-six) enterprises should establish a quality management system according to the regulations, rules and related documents of medical device management and the implementation standards of medical device enterprises (wholesale) in Jiangsu Province, and combine the actual situation of enterprises, and have measures to ensure its implementation; Establish quality management records and quality management files such as incoming inspection records and sales records, and take measures to ensure the authenticity and integrity of their contents; Orthokeratology mirror business enterprises should formulate relevant management systems according to the characteristics of orthokeratology mirrors and strictly implement them.
(twenty-seven) plastic contact lens business enterprises should have comprehensive training capabilities including products, equipment, facilities and personnel. To the installation mechanism; Collect the adverse reactions of the wearer after wearing orthokeratology lens, effectively handle the complaints of the wearer, and keep the relevant records of handling.
(twenty-eight) Orthokeratology mirror business enterprises shall recognize and authorize fitting institutions, sign letters of responsibility, and determine their respective responsibilities in the after-sales service of products; Only products can be provided to the fitting institutions recognized by them.
(twenty-nine) other state food and drug administration has clear requirements for the operation of medical devices that need special management and operation qualifications and conditions, from its provisions.
Retail of medical devices of the third category
(a) the person in charge of the enterprise shall be familiar with the laws and regulations on the supervision and administration of medical devices and the relevant knowledge of the medical devices it operates, and have no record of the acts mentioned in Articles 64 and 65 of the Regulations on the Supervision and Administration of Medical Devices.
(2) An enterprise shall be equipped with full-time quality management personnel (hereinafter referred to as quality control personnel) suitable for its business varieties, and each store shall be equipped with at least 1 person.
(three) the person in charge of enterprise quality shall exercise the quality management function according to the written authorization, and exercise the power of medical device quality judgment within the enterprise according to the authorization.
(four) the person in charge of quality should have a technical secondary school degree or above in medical devices or related majors or a junior technical title or above in related majors recognized by the state.
(5) The quality controller shall receive on-the-job training and can only take up his post after passing the examination. Quality inspectors should be on the job, not part-time in other units.
(6) Those who are over the statutory retirement age of the country shall not be over 68 years old as quality control personnel, and provide medical certificates issued by medical institutions at or above the second level in Nanjing.
(seven) the following products, should also be equipped with the following professionals:
(1) For those who are engaged in household medical device products, each store shall be equipped with at least 1 professional technicians above doctors or nurses.
(2) Those who deal in contact lenses (excluding plastic contact lenses) and their care solutions shall be equipped with two or more ophthalmologists or intermediate optometrists (with professional qualification certificates issued by the labor department).
(three) other medical device enterprises that need to be equipped for individuals shall be equipped with at least two professional and technical personnel with the title of doctor (or technician) or above or college degree or above in related majors.
(4) Personnel with employment access in the country must pass vocational skill appraisal and obtain a valid vocational qualification certificate before taking up their posts.
(5) The person in charge of the enterprise and the person in charge of quality shall not concurrently serve as the above-mentioned professional and technical personnel.
(8) Persons who undertake professional and technical work in enterprises beyond the national statutory retirement age shall not be over 70 years of age, and provide medical certificates issued by medical institutions at or above the second level in Nanjing.
(nine) the business premises should be located in the facade room which is convenient for consumers to buy. The business premises shall be spacious, bright, clean and hygienic, separated from office, living and storage, and shall not be located in residential buildings, military camps (excluding leasable areas) or other places unsuitable for business operation.
(10) The area of the business premises shall not be less than 40 square meters (subject to the construction area of the property right certificate, and the use area of the property right certificate × 1.2, the same below); Commercial enterprises such as supermarkets must have independent areas to operate medical devices. Franchise medical devices, with a business area of not less than 20 square meters (usable area); Those who run medical devices concurrently shall have a business area of not less than 30 square meters (usable area).
(eleven) the business premises should have a product showcase to display the medical device products it deals in. The counters and shelves are placed neatly, and the signs of the cabinet group are eye-catching. Retail pharmacies operating medical devices must set up counters (cabinets) to display medical devices, and medical devices and non-medical devices shall not be mixed.
(12) Those who engage in contact lenses (except plastic contact lenses) shall set up examination rooms (areas), optometry rooms, fitting rooms (areas) and other fitting places, and be equipped with fitting tables, hand washers, hand dryers, eye charts, ophthalmoscopes, mirror boxes, computer optometry instruments, slit lamp microscopes and other instruments and equipment.
(13) If the enterprise has the conditions to replenish the supply in time, it may not set up a warehouse, but all the products should be put on the shelves, put into the cabinet or placed in the exhibition area; If it is necessary to set up a warehouse, it should be suitable for its business scale and equipped with storage equipment suitable for its business varieties.
(fourteen) enterprises need to adapt or household medical devices, should have the ability of after-sales service or agree to the third party to give technical support.
(15) An enterprise shall be equipped with computer equipment and management software suitable for its business scale, be able to realize the computer data association with the local food and drug supervision department, upload relevant data such as purchase, sale and storage in time, and have the conditions to accept the supervision and management of the local food and drug supervision department through the remote supervision platform.
(sixteen) the enterprise shall, in accordance with the relevant laws, regulations and this standard, combine the actual situation and business scope of the enterprise, formulate the medical device quality management system, and have measures to ensure its implementation; Establish corresponding quality management records and files such as incoming inspection records and sales records, and take measures to ensure the authenticity and integrity of their contents.
(seventeen) retail chain enterprises to apply for the "medical device business license", shall comply with the relevant requirements of the medical device business enterprise (retail) license acceptance standards.
(eighteen) a retail chain enterprise shall set up a headquarters, and the headquarters shall separately apply for a business license for retail chain medical devices.
(nineteen) other requirements of the "institutions and personnel" of the headquarters of retail chain enterprises, including the requirements for the qualifications of personnel related to quality management, shall be implemented with reference to the "Acceptance Standards for Medical Device Enterprises (Wholesale) in Jiangsu Province". The headquarters of a retail chain enterprise shall designate one person as the person in charge of quality in the top management to be responsible for the overall quality management of the enterprise. The head of the headquarters of a retail chain enterprise shall not concurrently be the person in charge of quality. A quality management organization shall be established, which shall be composed of at least three people, including the person in charge of the quality management organization. The person in charge of quality shall not concurrently be the person in charge of the quality management organization and the store quality controller. If a pharmaceutical retail chain enterprise deals in medical devices, the person in charge of quality, the person in charge of the quality management organization and the person in charge of quality may be concurrently appointed by the corresponding pharmaceutical quality management personnel.
(twenty) the retail chain enterprise headquarters "business premises and facilities", "management and system" and other related requirements with reference to the "medical device business enterprise (wholesale) acceptance standard" implementation. Business premises can be located in relatively independent houses without facades, but not in residential buildings, military camps (excluding leasable areas) and other places that are not suitable for business operations. The business area is not less than 65,438+000 square meters. Distribution centers should be set up to adapt to the business scale and variety of enterprises. The medical devices operated by each store are purchased by the headquarters and distributed by the distribution center. The distribution center shall be equipped with a warehouse with an area of not less than 100 square meter.
(twenty-one) the branches of the retail chain medical device enterprises or the head office shall bear corresponding legal responsibilities, and their business scope shall not exceed the business scope of the head office or the head office.
(twenty-two) if the State Food and Drug Administration of the United States has clear requirements on the qualifications and conditions for the operation of some medical devices that need special management, such provisions shall prevail.
Four. Application material
(1) Wholesale of Class III medical devices
1. The cover and contents of the application materials (including serial number, material name and page number);
2 medical device business license application form;
3. Copy of business license and organization code certificate;
4, enterprise organization and department settings;
5. Description of business mode and business scope (determined according to the name, code and management category specified in the Catalogue of Medical Devices);
6, enterprise personnel list (indicate the name, gender, age, education, major, title, position, ID number);
7. Copy of the ID card of the legal representative of the enterprise, the ID card of the person in charge of the enterprise and the training certificate; Business in vitro diagnostic reagents, plastic contact lenses, need to provide a copy of the education certificate of the person in charge of the enterprise;
8. Resumes, letters of appointment, ID cards, academic certificates, professional title certificates, employment certificates, employment contracts and photocopies of non-part-time certification materials of the person in charge of quality and the person in charge of quality institutions; The person in charge of quality shall also provide the Power of Attorney for Quality Management of Medical Device Enterprises; Copies of academic qualifications, employment certificates, employment contracts and non-part-time certificates of specific quality management personnel; If the above-mentioned personnel are over the legal retirement age, they should also provide a retirement certificate and a copy of the medical certificate issued by a medical institution at or above the second level in Nanjing that can work normally;
9, acceptance, maintenance, after-sales service, sales and other personnel ID cards, academic certificates, job certificates and other related materials;
10. Enterprises engaged in implantable medical devices and plastic contact lenses need to provide copies of medical technicians' ID cards, education certificates, labor contracts and non-part-time certification materials; If the retirement age exceeds the legal retirement age, a copy of the retirement certificate and a medical certificate issued by a medical institution at or above the second level in Nanjing that can work normally shall also be provided;
1 1, the lease agreement of the business premises and warehouse, and a copy of the property right certificate; The plan of the business place (indicating the actual use area) and the geographical location map; Warehouse plan (indicating the actual use area and zoning) and geographical location map;
12, list of office, warehousing, transportation and other facilities and equipment; To operate in vitro diagnostic reagents, it is also necessary to provide photos of the reservoir area, photos of the appearance in the cold storage, photos of refrigerated trucks or on-board refrigerators, photos of transport vehicles, and photos of generators equipped with generators;
13. If a medical device manufacturer applies for the Medical Device Business License, it shall provide a copy of the Medical Device Production License or the filing certificate; Plans of offices, production sites and warehouses;
14. The enterprise that entrusts the third-party logistics storage and transportation needs to provide a copy of the entrusted third-party logistics storage and transportation contract;
15, basic introduction and function description of computer information management system; For the enterprise that entrusts the third-party logistics storage and transportation, the description shall include real-time docking, inquiry and supervision with the network and database of the third-party logistics enterprise;
16, enterprise quality management system, working procedures and other documents;
17, copy of the agent's authorization certificate and ID card;
18, other supporting materials that need to be provided further;
19, enterprise's statement on the authenticity of application materials for administrative license (administrative confirmation).
20. China Food and Drug Administration has clear requirements on the qualifications and conditions of some medical devices that need special management, and submits materials according to its provisions.
(II) Retail of Class III medical devices
1. The cover and contents of the application materials (including serial number, material name and page number);
2 medical device business license application form;
3. Copy of business license and organization code certificate;
4. If the enterprise is a retail chain medical device enterprise store or a branch of the head office, it shall provide a copy of the medical device business license and business license of the head office or the head office;
5. Description of business mode and business scope (determined according to the name, code and management category specified in the Catalogue of Medical Devices);
6, enterprise personnel list (indicate the name, gender, age, education, major, title, position, ID number);
7. Copy of the ID card of the legal representative of the enterprise, the ID card of the person in charge of the enterprise and the training certificate;
8. Resume and letter of appointment of full-time quality controller; Copy of ID card, diploma or title certificate, on-the-job certificate, labor contract and non-part-time certification materials; Power of attorney for quality management of medical device management enterprises; Full-time quality inspectors who exceed the statutory retirement age shall also provide retirement certificates and copies of medical certificates issued by medical institutions at or above the second level in Nanjing that can work normally;
9. For three types of personal medical devices, such as household medical devices, contact lenses and nursing fluids, and other retail enterprises that need to be equipped with professional and technical personnel (fitting personnel), it is also necessary to provide ID cards, academic certificates, professional title certificates, professional qualification certificates, technical grade certificates, copies of labor contracts and non-part-time certification materials of corresponding professional and technical personnel (fitting personnel); If the retirement age exceeds the legal retirement age, a copy of the retirement certificate and a medical certificate issued by a medical institution at or above the second level in Nanjing that can work normally shall also be provided;
10, a copy of the lease agreement of the business premises and warehouse of the enterprise and the property right certificate of the house; General plan (indicating the actual use area and functional areas) and geographical location map;
1 1, enterprise management, warehousing, transportation and other facilities and equipment list; Retail enterprises engaged in fitting contact lenses, nursing solutions and other third-class medical devices, but also need to provide a list of fitting devices (indicating the name, specification, manufacturer, device number and quantity) and a description of fitting conditions;
12. Retail enterprises without warehouses need to provide timely replenishment and supply conditions for medical devices;
13, basic introduction and function description of computer information management system;
14, enterprise quality management system, working procedures and other documents;
15, copy of the agent's authorization certificate and ID card.
16, other supporting materials that need to be provided further;
17, enterprise's statement on the authenticity of application materials for administrative license (administrative confirmation).
Verb (abbreviation for verb) Description and requirements of the report:
1. The Application Form for Medical Device Business License can be downloaded from the website of the US Food and Drug Administration.
2. Please refer to the "Model Text" for the filling format. Written materials and forms are printed by computer, and all materials are printed on A4 paper.
3. The copy provided shall indicate that the copy is consistent with the original and the date of copying, and shall be stamped with the official seal of the enterprise;
4. The addresses of merchants and warehouses shall be published in the order of "city name+district name+road name+house number+floor+room number";
5. The business scope shall be filled in according to the management category, category code and category code name specified in the Catalogue of Medical Devices promulgated by China Food and Drug Administration, and not only "three types of medical devices";
6. The product description of the general retail third-class medical devices shall have a special description that the products can be used by consumers themselves. Only the following scope: Category III: 68 15 disposable sterile syringe (including needle), 68 15 special needle for insulin injection pen, 6822 contact lens and nursing solution (excluding plastic contact lens), and 6866 condom (including medicine). Beyond this range, it shall submit a copy of the retail instructions and related instructions of medical devices;
7, retail chain enterprise headquarters to apply for the "medical device business license", the application materials refer to the requirements of medical device wholesale enterprises;
8. If the enterprise is a branch or head office of a retail chain store, the application materials for medical device business license shall be uniformly applied by the head office or head office, and the submitted materials shall be stamped with the seal of the head office or head office;
9. The application materials for the third-class medical device wholesale and retail enterprises with business premises and warehouse addresses in Jiangning District, Liuhe District, Pukou District, Lishui District and Gaochun District and for opening the third-class medical device pharmacy in six urban areas of this Municipality in duplicate;
10, online synchronous declaration (for details, please refer to the User Manual of Jiangsu Medical Device Information Collection System Enterprise).
Six, the handling of relevant issues during the transition period
1. From 20141kloc-0/,the business license of medical device business enterprise shall be handled in accordance with the relevant provisions of the Measures for the Supervision and Administration of Medical Device Business. 20 14 10 1 previously accepted but not approved applications for medical device business licenses shall also be handled in accordance with the relevant provisions of the Measures for the Supervision and Administration of Medical Device Business.
2, the existing medical device business enterprise "medical device business enterprise license" will continue to be valid within the validity period. After 20 14, 10 and 1, if an enterprise applies for change, extension or renewal of its business license, which involves the operation of Class III medical devices, it shall be reviewed in accordance with the relevant requirements of the Measures for the Supervision and Administration of Medical Device Operation. Meet the prescribed conditions, issue a new medical device business license and withdraw the original certificate;
3. Individual industrial and commercial households holding a valid Medical Device Business License can only renew the Medical Device Business License after the business license is converted into a business license;
4. The application for renewal of the Medical Device Business License is valid. If it does not involve the renewal of license, or only involves the change or replacement of non-licensed items, on-site inspection may not be carried out. If it meets the requirements, it shall be renewed, and the validity period of the license shall remain unchanged; If the licensing matters are changed or postponed, and the materials and on-site inspection meet the requirements, the license shall be renewed, and the validity period of the license shall be calculated from the date of issuing the license.
5. From 20 14, 10, 1, the original online examination and approval system for medical device business license ceased to be used. The opening time of the new online business license approval system will be notified separately.