3, "supervision and management of medical devices business" (State Food and Drug Administration Bureau Decree No. 8);
4, "Food and Drug Administration on the implementation of the "supervision and management of medical device production" and "supervision and management of medical devices business" notice of the relevant matters" (food and drug supervision and supervision of medical devices [2014]) 143);
5, "on the implementation of the "supervision and management of medical equipment production" and "supervision and management of medical equipment business approach" related matters of notice" (Su food and drug supervision and management of medical equipment [2014] 235);
6, "on the issuance of the acceptance of the license of medical equipment business enterprises in Jiangsu Province, notice" (Su food and drug supervision regulations [2011] No. 1);
Second, the applicant qualifications
Holding an enterprise business license and organization code certificate of all types of enterprises. Handling of Class III medical device license application affairs of the operator should be entrusted by the applicant, and familiar with relevant laws, rules and regulations and the requirements of the matters handled.
Third, the application conditions
Wholesale of Class III medical devices
(a) The person in charge of the enterprise should be familiar with the supervision and management of medical devices, rules and regulations and the relevant knowledge of the medical devices operated, no "supervision and management of medical devices regulations," Article 64, 65 of the record of the behavior described. Operating in vitro diagnostic reagents, plastic corneal contact lenses, the person in charge of the enterprise shall have a college degree or above.
(ii) the enterprise may designate a top management personnel as the person in charge of quality, responsible for the overall quality management of the enterprise. The person in charge of the enterprise may not also be responsible for quality.
(c) the enterprise should set up quality management organization (at least three people by the head of the quality management organization). The person in charge of the enterprise shall not also be responsible for quality management organization and quality control.
(d) the enterprise quality officer, quality management agencies in charge of written authorization to exercise their respective quality management functions, and within the enterprise in accordance with the authorization to exercise the right to rule on the quality of medical devices.
(E) enterprises should be set up or equipped with the scale of operation, business varieties appropriate medical device acceptance, maintenance and other departments. Acceptance, maintenance department should be subordinate to or in business to accept the supervision and guidance of the quality management organization.
(F) the enterprise shall set up with the scale of operation, business varieties appropriate technical training and after-sales service department/personnel or agreed by a third party to provide technical support.
(VII) the person in charge of quality should have medical equipment or related professional college degree or above or nationally recognized technical title above the junior level of relevant professions (relevant professions refer to machinery, electronics, medicine, pharmacy, bio-engineering, chemistry, nursing, computers, and other science, engineering, agriculture, medicine, medicine, medicine, etc., the same below). The person in charge of quality should be familiar with the supervision and management of medical devices, rules and regulations and the relevant knowledge of the medical devices and have a certain amount of practical experience.
In vitro diagnostic reagents business enterprises, the quality of the person in charge should have a bachelor's degree or higher and related professional (testing, microbiology, medicine, pharmacy, biochemistry, etc., hereinafter the same) intermediate or higher title, familiar with the relevant laws and regulations, and more than 5 years of in vitro diagnostic reagents in the relevant work experience.
(viii) The person in charge of the quality management organization shall have a bachelor's degree or above in medical devices or related disciplines, or a nationally recognized technical title of intermediate or above in the relevant disciplines, and have more than 2 years of experience in medical device-related work.
In vitro diagnostic reagents business enterprises, the quality management organization shall have a bachelor's degree or above and related professional (testing, microbiology, medicine, pharmacy, biochemistry, etc., hereinafter the same) intermediate or above, familiar with the relevant laws and regulations, and more than 5 years of in vitro diagnostic reagents engaged in related work experience;
(ix) the person in charge of quality, quality management organization of the enterprise The person in charge shall be on duty, shall not work part-time in other units, no serious violations of medical device regulations and behavior records.
(J) the person in charge of quality, quality management organization should receive induction training, pass the examination before taking up their duties.
(k) more than the national legal retirement age of the person in charge of quality management organization as a business, its age shall not exceed 68 years old, and shall provide a certificate of medical examination issued by a medical institution above the second level in Nanjing.
(xii) The application for the operation of implantable products should also be equipped with two personnel with undergraduate education in medical specialties and trained by the manufacturer or supplier, who are on duty and may not work part-time in other organizations. More than the national statutory retirement age of personnel to undertake this work, their age shall not exceed 65 years old, and shall provide a certificate of medical examination issued by a medical institution 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 corneal contact lenses business enterprises, shall have ophthalmology-related professional technical service personnel.
(xiii) personnel engaged in specific quality management, acceptance and maintenance, measurement and other work, shall have a high school or secondary school education, after the relevant training and assessment of qualified to work. In the country have employment access to work in the post, the personnel need to pass the vocational skills assessment and obtain a valid vocational qualification certificate before taking up the post.
In vitro diagnostic reagent business enterprises, engaged in specific quality management, acceptance, after-sales service personnel should have relevant professional secondary school education; maintenance, sales and other personnel should have high school or secondary school education. Quality management, acceptance, maintenance, sales, after-sales service and other work positions, should receive pre-service training, after passing the examination before taking up their posts.
(xiv) engaged in quality management, acceptance, custody, sales and other direct contact with medical device products, personnel should be a yearly health check and establish a file. Suffering from infectious diseases or mental illness, shall not be engaged in direct contact with medical equipment products.
(xv) The registered capital of the enterprise shall be not less than one million yuan. The scope of business more than eight categories, each additional category, the registered capital should be an additional 500,000 yuan. Medical device manufacturers to apply for a medical device license, production, operation of personnel, premises, warehouses, equipment and facilities should be set up separately and independently, the total registered capital should be not less than 5 million yuan.
In vitro diagnostic reagents business enterprises, the registered capital of not less than 3 million yuan.
(xvi) business premises should be relatively independent, and its scale and scope of business is appropriate. Business premises shall not be located in residential homes, military camps (excluding leasable areas) and other places not suitable for business. Business premises must be clean, bright and sanitary. Operation of Class III medical devices 8 categories and the following, the business premises area of not less than 100 square meters (excluding warehouses, to the building area of the certificate of property rights, no certificate of property rights to the use of the area × 1.2, the same below); operation of more than 8 categories of business premises area of not less than 200 square meters.
In vitro diagnostic reagent business enterprises, the business premises shall not be less than 200 square meters.
(xviii) enterprises should set up product showroom or product display cabinets, display products for business. Business products are not suitable for display, should be hung in the business premises business product pictures and product information.
(19) the enterprise should have with the scale of operation, scope of business, business varieties of appropriate warehouses, warehouses shall not be located in residential areas, military camps (excluding leasable areas) and other places not suitable for setting up warehouses. Warehouse locations should be set up to take into account the convenience of management and proximity to the principle of business premises. Business Class III medical devices 8 categories and the following, if the warehouse address and business premises with the same address or adjacent address (the same or adjacent door number, the same below), the warehouse area of not less than 50 square meters (including shade library, the same below); if the warehouse address and business premises, the warehouse area of not less than 80 square meters (with not less than 20 square meters of auxiliary business premises); business more than 8 categories, if the warehouse address and business premises with the same address or adjacent address, the warehouse area of not less than 80 square meters (with not less than 20 square meters of auxiliary business premises); business more than 8 categories, if the warehouse address and Operating more than eight categories, if the warehouse address and business premises with or adjacent to the address, the warehouse area of not less than 80 square meters; if the warehouse address and business premises with a different address, the warehouse area of not less than 150 square meters (with not less than 20 square meters of auxiliary business premises). Business needs to be cool storage of products, should be equipped with not less than 20 square meters of cool storage; business has a cold storage requirements of products, should be equipped with not less than 10 cubic meters of cold storage facilities. Business requires special conditions for the storage of products, should have the appropriate storage conditions.
In vitro diagnostic reagents business enterprises, if the warehouse address and business premises with the same address or neighboring sites (the same or adjacent door number), the total area of its warehouse not less than 100 square meters; if the warehouse address and business premises with the address of the warehouse area of not less than 150 square meters (with not less than 20 square meters of auxiliary business premises). Warehouse should be set up not less than 20 square meters of cool storage; should be set up cold storage, its volume should be compatible with the scale of operation, cold storage volume should be not less than 20 cubic meters.
(xx) warehouse temperature and capacity should be set with the business varieties and their scale of operation. Room temperature warehouse temperature of 0-30 ℃, cool warehouse temperature of 0-20 ℃, cold storage (cabinet) temperature of 2-10 ℃. Special product library temperature set according to the requirements of the product specification. The relative humidity of room temperature warehouse and cool warehouse is 40-80%. The humidity of special products is set according to the requirements of product specifications.
(xxi) around the warehouse area should be free of weeds, no pollution; loading and unloading places should have a roof; warehouse should be clean and hygienic, doors and windows of the structure of the tight, level ground, facilities are in good condition, there are appropriate mats, shelves, temperature and humidity control equipment, temperature and humidity meter, and has a shelter from the light, pests, rodent-proof, mildew, anti-pollution, moisture-proofing, ventilation, lighting and fire protection and other facilities.
Operation of in vitro diagnostic reagents, the warehouse should also be equipped with effective automatic control, detection of temperature and humidity equipment; cold storage should be equipped with automatic monitoring, control, display, record temperature conditions and automatic alarm equipment and backup generator set or installation of dual-channel circuits, standby refrigeration unit; set up the storage of packaged materials and equipped with the appropriate equipment.
(xxii) the warehouse should be clearly marked, respectively, set up to be inspected (library) area, shipping (library) area, qualified library (area), unqualified library (area), return library (area). Library should implement color-coded management, qualified areas and shipping areas for the green, unqualified areas for the red, to be inspected and returned areas for the yellow. Product stacking should be obvious signs and location card, between the stacks, stacks between the walls, stacks should be a certain distance between the top.
(xxiii) in vitro diagnostic reagents business enterprises, there should be compatible with the scale of operation and business varieties, in line with the in vitro diagnostic reagents storage temperature and other characteristics of the transportation facilities and equipment (such as refrigerated trucks, car refrigerators, etc.). Enterprises should be equipped with at least two sets of 40L refrigerator (maximum range of minus 18 degrees), and equipped with real-time monitoring of the temperature during transportation devices or meters.
(xxiv) business implantable products, plastic corneal contact lenses, should have a bar code and other unique identification records and long-term tracking of the first distributor or the use of units or users of the ability and conditions. Plastic corneal contact lenses business enterprises should be developed with the production unit, "plastic corneal contact lenses use of responsibility" triplicate, stamped with the unit's seal, along with the product is provided to the fitting agency.
(25) The enterprise should be equipped with computer equipment and management software appropriate to its scale of operation, and can realize the computer data linkage with the local food and drug regulatory authorities, timely uploading of purchase, sale, inventory and other relevant data, with the local food and drug regulatory authorities through the remote monitoring platform for supervision and management of its purchase, sale, inventory conditions.
(xxvi) The enterprise shall establish a quality management system in accordance with the rules and regulations of medical device management, relevant documents and the "Jiangsu Province Medical Device Business Enterprise (Wholesale) Inspection and Implementation Standards", combined with the actual situation of the enterprise, and have measures to ensure the implementation of the quality management system; the establishment of the purchase and inspection records, sales records and other quality management records, quality management files and have measures to ensure that the authenticity of the contents and Integrity; plastic corneal contact lenses business enterprises should develop relevant management system for the characteristics of corneal plastic contact lenses and strictly implemented.
(27) The business enterprise of plastic corneal contact lenses shall be able to provide comprehensive training capability including products, equipments, facilities, personnel, etc. to the dispensing organization; collect the adverse reactions of the wearers after wearing the corneal plastic lenses, deal with the complaints of the wearers effectively, and keep the relevant records of the treatment.
(28) Plastic corneal contact lenses business enterprises should be accredited and authorized by the dispensing institutions, and sign a letter of responsibility to determine their respective responsibilities in the after-sales service of the products; and can only provide the products to its accredited dispensing institutions.
(XXIX) the operation of other State Food and Drug Administration on its need for special management, business qualifications and conditions have clear requirements for medical devices, from its provisions.
The third class of medical devices retail
(a) The person in charge of the enterprise should be familiar with the supervision and management of medical devices, rules and regulations and the relevant knowledge of the medical devices operated by the person in charge of the enterprise, without the "supervision and management of medical devices regulations" Article 64, 65 described in the behavioral records.
(ii) The enterprise shall be equipped with full-time quality management personnel (hereinafter referred to as quality control personnel) appropriate to the types of business, at least one per store.
(C) enterprise quality control officer in accordance with the written authorization to exercise quality management functions, and within the enterprise in accordance with the authorization to exercise the right to rule on the quality of medical devices.
(d) The quality control officer shall have a medical device or related professional secondary school education or nationally recognized technical title of junior or above in the relevant professional.
(E) quality control officer shall receive induction training, pass the examination before taking up their duties. Quality control officer should be on duty, not in other units part-time.
(6) If a person exceeds the legal retirement age of the state as a quality control officer, he shall not be older than 68 years old and shall provide a certificate of medical examination issued by a medical institution of the second class or above in Nanjing.
(vii) If the following products are operated, the following professionals shall also be provided:
(1) If the products are operated as medical devices for household use, at least one professional and technical personnel of physician or nurse practitioner or above shall be provided for each store.
(2) the operation of corneal contact lenses (excluding plastic corneal contact lenses) and their care fluids, should be equipped with more than 2 (including 2) ophthalmologists or intermediate optometrists (with professional qualifications issued by the labor department) or more relevant professional and technical personnel.
(3) the operation of other medical devices required for personal examination and dispensing enterprises, should be equipped with at least 2 or more (including 2) physicians (or technicians) above the title or related professional and technical personnel with college education or above.
(4) In the country with employment access to work in the post, need to pass the vocational skills appraisal and obtain a valid vocational qualification certificate before taking up the job.
(5) The person in charge of the enterprise and the quality control officer shall not work as the above professional and technical personnel at the same time.
(8) Personnel over the national statutory retirement age to undertake professional and technical work in the enterprise shall not be older than 70 years old, and shall provide a certificate of passing the physical examination issued by a medical institution of the second level or above in Nanjing.
(ix) The business premises shall be located in a storefront room that is convenient for consumers to purchase. The business premises should be spacious, bright, clean and hygienic, and office, living, storage and other areas should be separated, and shall not be located in residential housing, army camps (excluding leasable areas) and other places not suitable for business.
(J) the business area should be not less than 40 square meters (to the building area of the certificate of property rights, no certificate of property rights to the use of the area × 1.2, the same below); in the supermarkets and other commercial enterprises operating medical devices, must have an independent area. Specializing in medical devices, the business area of not less than 20 square meters (using the area); part-time medical devices, the business area of not less than 30 square meters (using the area).
(XI) business premises should have product display cabinets, display of medical equipment products. Counter and shelves neatly, cabinet sign conspicuous. Retail pharmacies and medical devices must set up a special cabinet (cabinet) display of medical equipment, medical equipment and non-medical equipment shall not be mixed.
(xii) the operation of corneal contact lenses (excluding plastic corneal contact lenses), should be set up in the examination room (area), optometry, fitting room (area) and other places of testing and dispensing, equipped with a fitting table, hand wash basin, hand dryer, visual acuity meter, checking glasses, lens box, computerized optometry, slit lamp microscope and other instruments and equipment.
(xiii) enterprises with timely replenishment, supply conditions, may not set up warehouses, but the products should be all shelves, cabinets or placed in the display area; need to set up warehouses, should be compatible with the scale of its operations, equipped with storage and safekeeping equipment appropriate to the types of business.
(xiv) the need for business fitting or home use of medical equipment, should have the ability to provide after-sales service or agreed to a third party to give technical support.
(15) The enterprise should be equipped with computer equipment and management software appropriate to its scale of operation, and can realize the computer data linkage with the local food and drug regulatory authorities, timely uploading of purchase, sale, inventory and other relevant data, with the local food and drug regulatory authorities through the remote monitoring platform for the supervision and management of its purchase, sale, inventory conditions.
(p) The enterprise should be in accordance with relevant laws, regulations and this standard, combined with the actual business and the scope of business, the development of medical device quality management system, and measures to ensure that it is implemented; the establishment of the corresponding purchase inspection records, sales records and other quality management records and archives, and measures to ensure the authenticity and integrity of its content.
(xvii) retail chain stores to apply for the "Medical Device License", should be consistent with the relevant requirements of the medical device business enterprise (retail) license acceptance criteria.
(xviii) retail chain enterprises should be set up headquarters, the headquarters should be a separate application for retail chain "Medical Device License".
(19) retail chain headquarters "institutions and personnel" of other requirements, including quality management personnel qualifications and other requirements with reference to the "Jiangsu Province, medical device business enterprises (wholesale) acceptance criteria. Retail chain enterprise headquarters shall designate a top management personnel as the person in charge of quality, responsible for the overall quality management of the enterprise. The head of the retail chain enterprise headquarters shall not also serve as the person in charge of quality. Quality management organization should be set up, quality management organization at least three people by the head of the quality management organization. The person in charge of quality shall not concurrently serve as the head of the quality management organization and the store quality control officer. Drug retail chain enterprises operating medical devices, the quality of the person in charge, the head of the quality management organization and the quality control officer can be the corresponding drug quality management personnel.
(xx) retail chain headquarters of the "premises and facilities", "management and system" and other relevant requirements with reference to the "medical device business enterprises (wholesale) acceptance criteria". Business premises can be located in a relatively independent non-front room, but shall not be located in residential homes, military camps (excluding leasable areas) and other places not suitable for business, the business premises area of not less than 100 square meters. Distribution centers shall be set up to match the scale of business and the types of business. The medical devices operated by each store shall be purchased by the headquarters and distributed by the distribution center. Distribution center should be set up warehouse, warehouse area of not less than 100 square meters.
(xxi) retail chain of medical equipment enterprise stores or stores of the head office, the headquarters or the head office to assume the corresponding legal responsibility, its scope of business shall not exceed the headquarters or the head office of the business scope.
(xxii) The State Food and Drug Administration on some of the medical devices require special management of business qualifications and conditions have clear requirements, from its provisions.
Four, application materials
(A) Class III medical device wholesale
1, the declaration of materials cover and directory (including serial number, material name, page number);
2, "Medical Device License Application Form";
3, "Business License" and "Organization Code Certificate" a copy of the "Organization Code Certificate";
4, business organization Institutions and departments set up to explain;
5, the mode of operation, the scope of business description (in accordance with the medical device classification directory of the name, code and management category to determine);
6, the list of personnel of the enterprise (specify the name, gender, age, education, profession, professionalism, title, position, identity card number);
7, a copy of the identity card of the legal representative of the enterprise, a copy of the identity card and training certificate of the person in charge of the enterprise A copy of the identity card and training certificate of the person in charge; operating in vitro diagnostic reagents, plastic corneal contact lenses, you need to provide a copy of the educational certificate of the person in charge of the enterprise;
8, the person in charge of quality, the person in charge of the quality organization's curriculum vitae, letter of appointment, identity card, academic certificates, title certificates, certificates of employment and labor contracts, not part-time certificates copy; the person in charge of quality should also provide Medical device business enterprise quality management authorization; specific quality management personnel's academic certificates, certificates and labor contracts, not a copy of part-time materials; the above personnel over the statutory retirement age, should also provide a certificate of retirement and medical institutions above the second level of Nanjing City, a copy of the medical examination issued by the ability to work normally;
9, acceptance, maintenance, after-sales service, sales and other personnel ID card, academic certificate, a copy of the induction certificate and other related materials;
10, the operation of implantable medical devices, plastic corneal contact lenses enterprises, need to provide medical and technical personnel ID cards, academic certificates, labor contracts, not part-time certificates copies; over the legal retirement age, should also provide retirement certificates and medical institutions above the second level of Nanjing City, a copy of the medical examination certificate issued by the ability to work properly Proof of copy;
11, business premises, warehouse lease agreement, a copy of proof of property rights; business premises plan (indicating the actual use of the area) and geographic location map; warehouse plan (indicating the actual use of the area and partitioning) and geographic location map;
12, office, warehousing, transportation and other facilities, equipment lists; operating in vitro diagnostic reagents, you also need to provide Photos of the warehouse area, photos of the appearance of the cold storage, refrigerated trucks or car refrigerators, photos of transport vehicles, generators equipped with generators to provide generator photos, etc.;
13, medical device manufacturers applying for the "Medical Device Business License", you need to provide "Medical Device Manufacturing License" or a copy of the filing vouchers; office, production sites and their warehouse floor plans;
14, entrusted to a third party Logistics storage and transportation enterprises, need to provide a copy of the commissioned third-party logistics storage and transportation contract;
15, the basic information and functional description of the computer information management system; commissioned third-party logistics storage and transportation enterprises, the description should include real-time docking with the third-party logistics companies, querying, supervision and other network and database;
16, enterprise quality management system, work procedures and other documents;
17, the operator's authorization certificate and a copy of ID card;
18, other proof of the need for further information;
19, the enterprise's administrative licensing (administrative confirmation) of the authenticity of the application materials to ensure that the statement.
20, the State Food and Drug Administration on some of the need for special management of medical devices business qualifications and conditions have clear requirements, according to its regulations to submit materials.
(B) the third class of medical devices retail
1, reporting materials cover and directory (including serial number, material name, page number);
2, "Medical Device License Application Form";
3, "business license" and "Organization Code Certificate" copy;
4, the enterprise is a retail chain of medical device enterprise stores or head store If the enterprise is a branch of a retail chain of medical devices enterprise stores or head office, it is required to provide the headquarters or head office of the Medical Device Business License, a copy of the "business license";
5, the mode of operation, the scope of business description (in accordance with the medical device classification directory of the name, code and management category to determine);
6, the list of personnel of the enterprise (indicating the name, gender, age, education, professional, title, position, identity card number)
7, a copy of the enterprise's legal representative ID card, the person in charge of the enterprise's ID card and a copy of the training certificate;
8, full-time quality control officer's resume, appointment letter; ID card, academic certificate or title certificate, induction certificate, labor contract, not part-time certificates copies of materials; medical device business enterprise quality management authorization; more than the legal age of retirement as a Full-time quality control officer, should also provide proof of retirement and medical institutions above the second level in Nanjing City, a copy of the physical examination issued by the ability to work properly;
9, the operation of home use of Class III medical devices, corneal contact lenses and nursing fluids and other personal examination and dispensing of Class III medical devices, as well as other need to be equipped with professional and technical personnel (fitting personnel) of the retail business, but also need to provide the appropriate professional and technical personnel (fitting personnel) identity cards, academic qualifications, and the corresponding professional and technical personnel (fitting personnel), and the quality management authorization of the medical device business. Dispensers) of identity cards, academic certificates, title certificates, professional qualification certificates, technical grade certificates and labor contracts, not part-time certificates; more than the statutory retirement age, should also provide a certificate of retirement and medical institutions above the second level of Nanjing City, a copy of the medical examination issued by the ability to work normally;
10, the enterprise's business premises, warehouses of the lease agreement, the property rights of the housing Proof of copies; site plan (indicating the actual use of the area and the functional areas) and geographic location map;
11, business operations, warehousing, transportation and other facilities, equipment lists; operation of corneal contact lenses and nursing fluids and other dispensing class III medical device retailers, but also need to provide a list of dispensing instruments (indicating the name, specifications, manufacturer, instrument number, number) and conditions of testing and dispensing
12, not set up warehouses in the retail business, you need to provide medical equipment in a timely manner to make up, supply conditions;
13, computer information management system basic information and functional description;
14, enterprise quality management system, work procedures and other documents;
15, proof of authorization of the operator and a copy of the ID card.
16, other supporting materials that need to be provided further;
17, the enterprise on the administrative licensing (administrative confirmation) application materials to ensure the authenticity of the statement.
Fifth, fill in the instructions and requirements:
1, "Medical Device License Application Form" can be downloaded to the Nanjing Food and Drug Administration website download area
2, fill in the format with reference to the "model text", the text material and forms printed on computer, all the information on A4 paper;
3, the copies provided shall indicate the copy and the original and the date of copying, and stamped with the seal of the enterprise;
4, business, warehouse address should be published in accordance with the "city name + district name + road name + door number + floor + room number" order;
5, the scope of business should be in accordance with the State Food and Drug Administration issued by the Medical Device Classification Catalog of the management category, classified catalog class code and class code name to fill in, shall not fill in only "Class III medical devices";
6, can be retailed Class III medical devices should be available for consumers to use their own personal product manuals should be a product of the special Description. Only the following scope: Class III: 6815 single-use sterile syringes (including needles), 6815 insulin injection pen special needle, 6822 corneal contact lenses and care of fluids (excluding plastic corneal contact lenses), 6866 condoms (including drugs). Beyond this scope, should be submitted to the medical device retailable description and a copy of the relevant instructions;
7, the headquarters of the retail chain enterprises to apply for the "Medical Device License", the application materials with reference to the requirements of the medical device wholesalers;
8, the enterprise for the retail chain stores or head office of the branch, the medical device license application materials by the head office or head office of a unified Application, the submission of materials to be stamped with the headquarters or head office seal;
9, business premises, warehouse address in Jiangning District, Liuhe District, Pukou District, Lishui District, Gaochun District area of the third class of medical devices wholesale and retail enterprises and the city's six urban areas part of the third class of medical devices in the pharmacy application materials need to be in duplicate;
10, the online synchronization of the declaration (see "Jiangsu Province") Medical Device Information Collection System Enterprise Side User Manual").
Sixth, the handling of issues during the transition period
1, since October 1, 2014, the medical device business enterprise business license in accordance with the "supervision and management of medical devices business approach" relevant provisions of the medical device business license application has been accepted before October 1, 2014 but has not yet been approved, but also in accordance with the "supervision and management of medical devices business approach" relevant regulations The application will be processed. License" and withdraw the original license;
3, holding a valid "Medical Device Business Enterprise License" of the individual business license will be transformed into an enterprise business license before the replacement of the "Medical Device Business License";
4, the valid "Medical Device Business Enterprise License" to apply for reissuance of the "Medical Device Business License", if it does not involve the continuation of the license change, or only involves Non-permitted matters change or replacement, without on-site inspection, meet the requirements to be given to the reissue, the license is valid until the date of change; if it involves licensing changes or continuation, and the information as well as on-site verification are in line with the requirements to be given to the reissue of the license is valid from the date of issuance of the license.
5, since October 1, 2014, the original medical device business license online approval system to stop using. The new business license online approval system opening time to be announced.