July 27, 2007
Provincially Municipalities Food and Drug Administration:
Now the State Bureau "on the issuance of in vitro diagnostic reagents business enterprises (wholesale) acceptance criteria and start-up application procedures for the notice" (State Food and Drug Administration City [2007] No. 299) forwarded to you. Start-up application procedures notice" (State Food and Drug Administration City [2007] No. 299 ) forwarded to you, combined with the actual situation in our province to put forward the following requirements, please follow up and implement.
All applications for the operation of in vitro diagnostic reagents, application procedures and acceptance criteria in accordance with the implementation of this notice.
Second, the enterprise also applied for pharmaceuticals (national legal for blood rescreening, the use of radioactively labeled in vitro diagnostic reagents) and medical devices in vitro diagnostic reagents and submit the "Drug License Application Form" and "Medical Device Business License Application Form", after the site inspection and acceptance of in vitro diagnostic reagent business enterprises in line with the "in vitro diagnostic reagent business enterprises (wholesale)
Acceptance Criteria" and the "in vitro diagnostic reagent business enterprises (wholesale)
Criteria for Acceptance". In Vitro Diagnostic Reagent Business Enterprise (Wholesale) Start-up Application Procedures", can be issued at the same time the "Drug License" and "Medical Device Business Enterprise License".
Third, enterprises applying for the operation of in vitro diagnostic reagents only belong to the category of medical devices, only need to submit a medical device license application; if enterprises applying for the operation of in vitro diagnostic reagents only belong to the category of drugs, only need to submit a drug license application.
Four, the provincial municipalities Food and Drug Administration to take the initiative to carry out in vitro diagnostic reagents have been licensed to operate the daily supervision and management of enterprises, and actively explore effective supervision and inspection methods; combined with the province to carry out the rectification and standardization of the drug market order of the special action to increase the supervision and management of in vitro diagnostic reagents business enterprises, to ensure that the public use of medicines with the safe and effective use of equipment.
July 5, 2007
On the issuance of in vitro diagnostic reagents business enterprises (wholesale) acceptance criteria and start-up application procedures for the notice of the State Food and Drug Administration City [2007] No. 299
Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration (Drug Administration):
In order to strengthen in vitro diagnostic reagents franchise enterprise Supervision and management, standardize in vitro diagnostic reagent business behavior, according to the "Drug Administration Law", "Drug Administration Law Enforcement Regulations", "Regulations on the Supervision and Administration of Medical Devices" and "Drug License Management Measures", "Medical Devices License Management Measures", the State Bureau formulated the "In Vitro Diagnostic Reagent Business Enterprises (Wholesale) Acceptance Criteria" and "In Vitro Diagnostic Reagent Business Enterprises (Wholesale) Start-up Application Procedures". Hereby issued to you, please conscientiously implement.
Provincial (autonomous regions and municipalities) drug supervision and management departments of in vitro diagnostic reagent business enterprises (wholesale) acceptance criteria and in vitro diagnostic reagent business enterprises (wholesale) start-up application procedures for business enterprises, can be issued at the same time the "Drug License" and "Medical Device Business Enterprise License", the license approved scope of business is limited to in vitro diagnostic reagents.
The above in vitro diagnostic reagents franchise enterprises need to increase the scope of business, must be in accordance with the provisions of the relevant drug business, medical device business, re-apply for a "drug license" or "medical device business enterprise license. In vitro diagnostic reagent business enterprises must be in accordance with the "Drug Business Quality Management Standards" to engage in business activities.
Attachment: 1. In vitro diagnostic reagent business enterprise (wholesale) acceptance criteria
2. In vitro diagnostic reagent business enterprise (wholesale) start-up application procedures
3. In vitro diagnostic reagent business enterprise (wholesale) application review form
State Food and Drug Administration
May 23, 2007
Annex 1:
In vitro diagnostic reagent business enterprises (wholesale) acceptance criteria
Chapter I Institutions and Personnel
Article 1 Diagnostic reagent business enterprise's legal representative or person in charge of the enterprise, quality management personnel do not have the "Supervision and Administration of Medical Devices Regulations," Article 40, the "Drug Administration Law," Article 76, 83 of the circumstances.
The person in charge shall have college education or above, and be familiar with national laws, rules and regulations on diagnostic reagent management and knowledge of the diagnostic reagents operated.
The second shall have quality management personnel appropriate to the scale of operation, and the quality management personnel shall exercise quality management functions and have the right to rule on the quality of diagnostic reagents.
Article 3 of the quality management personnel, two people. 1 is a licensed pharmacist; 1 is the supervisor of the inspector, or with a university degree in testing related disciplines and engaged in testing related work for more than 3 years of work experience.
Quality management personnel should be on duty, not part-time.
Article IV acceptance, after-sales service personnel should have secondary school education in inspection; corporate custodianship, sales and other staff, should have a high school or secondary school education.
Article V quality management, acceptance, custody, sales and other work positions, should receive induction training, pass the examination before taking up their posts.
Chapter II System and Management
Article 6 shall be based on the laws and regulations of the management of drugs, medical devices and related documents to develop quality management documents in line with the actual enterprise, including quality management system, responsibilities, work procedures.
(1) The quality management system shall include: management of quality management documents; provisions for internal review; provisions for quality veto; management of diagnostic reagent purchase, acceptance, storage, sales, warehousing, transportation, after-sales service; management of diagnostic reagent expiration date; management of unqualified diagnostic reagents; management of diagnostic reagents returned; management of facilities and equipment; management of personnel training; management of personnel health status; computer information management. management; computerized information management.
(2) Quality management responsibilities should include: quality management, purchase, acceptance, storage, sales, transportation, after-sales service, information technology and other positions.
(3) work procedures shall include: procedures for quality management document management; procedures for diagnostic reagents purchase, acceptance, storage, sales, warehousing, transportation, after-sales service; procedures for the return of diagnostic reagents after sale; and procedures for the confirmation and treatment of unqualified diagnostic reagents.
Article VII shall establish the purchase, acceptance, sales, warehousing, transportation and other content of the quality management records.
Chapter III Facilities and Equipment
Article VIII should have a bright and clean office, business premises, the area should be compatible with the scale of operation, but not less than 100 square meters.
Article IX should be set up in line with the requirements of diagnostic reagent storage warehouse, its area should be compatible with the scale of operation, but shall not be less than 60 square meters, and the environment of the warehouse area is clean and tidy, no source of contamination; diagnostic reagent storage operations should be effectively isolated from other areas of business, office; warehouse walls, roofs, and floors should be clean and smooth, the structure of the doors and windows tight.
Article X Residential housing shall not be used as a warehouse.
Article XI shall be set up to store diagnostic reagents of cold storage, its volume should be compatible with the scale of operation, but shall not be less than 20 cubic meters. Cold storage shall be equipped with automatic monitoring, regulation, display, recording temperature conditions and automatic alarm equipment, standby generator sets or installation of dual circuit, standby refrigeration units.
Article 12 The warehouse for storing diagnostic reagents shall have the following facilities and equipment:
(1) equipment for effective isolation between diagnostic reagents and the ground;
(2) equipment for ventilation and avoiding direct sunlight;
(3) equipment for effective regulation and detection of temperature and humidity;
(4) lighting equipment that meets the requirements of storage operations;
(5) equipment for automatic monitoring and control of temperature conditions and display of automatic alarm. p>
(v) unqualified diagnostic reagents, returned diagnostic reagents dedicated storage area or facilities and equipment;
(vi) packaging materials storage space and equipment;
(vii) diagnostic reagents quality status should be implemented color-coded management, to be determined diagnostic reagents for yellow, qualified diagnostic reagents for green, unqualified diagnostic reagents for red.
Article XIII should be compatible with the scale of operation and business varieties, in line with the requirements of drug storage temperature and other characteristics of the transportation facilities and equipment.
Article XIV should have a computerized management information system to meet the whole process of diagnostic reagent management and quality control requirements, and can be realized to accept the local drug supervision and management department supervision conditions.
Article XV should be used to check the facilities and equipment, maintenance, calibration, repair, cleaning to establish a file.
Chapter IV acceptance results assessment
Article XVI on-site acceptance, should be a comprehensive inspection, acceptance, and make a positive or negative assessment of each item.
Article XVII of the acceptance or unqualified acceptance, according to "Drug License Management Measures" Article 8 (5) and "supervision and management of medical devices regulations" Article 24 of the relevant provisions of the implementation.
Article XVIII of the operation of special management of diagnostic reagents shall comply with relevant state regulations.
Article XIX of this standard since June 1, 2007 shall come into force.
Annex 2:
In vitro diagnostic reagent business enterprise (wholesale) start-up application procedures
Starting in vitro diagnostic reagent business enterprise (wholesale) in accordance with the following procedures for the "Drug License", "Medical Device Business Enterprise License":
(a) the applicant to the proposed enterprise location of the provinces, autonomous regions and municipalities directly under the central government drug supervision and management department to apply for preparations, and submit the application for the establishment of the drug license. Department of the preparatory application, and submit the following materials:
1. the proposed legal representative of the enterprise, the person in charge of the enterprise, the person in charge of quality of the original certificate of education, copies and biographical information;
2. the original certificate of qualification of licensed pharmacists, a copy of;
3. the original certificate of the supervisor of the inspector, a copy of;
4. the scope of the proposed product;
5. the proposed product range;
6. the proposed license for medical devices;
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5. Proposed business premises, equipment, storage facilities and the surrounding health environment.
(B) drug supervision and management department of the application made by the applicant, should be based on the following circumstances were made to deal with:
1. Application does not belong to the department's competence, it should be made instantly inadmissible decisions, issued a "notice of inadmissibility" and inform the applicant to the relevant (food) drug supervision and management department to apply for;
2. Application materials there can be corrected on the spot error, the applicant should be allowed to correct on the spot;
3. Application materials are not complete or do not meet the statutory form, it should be issued on the spot or within five working days to the applicant, "Supplemental Materials Notice", a one-time notice of the need to make corrections to the full content. Late notification, from the date of receipt of the application materials shall be accepted;
4. Application matters within the purview of the department, the materials are complete, in accordance with the statutory form, or the applicant to submit all the corrective materials as required, issued to the applicant, "Notice of Acceptance". The date indicated in the Notice of Acceptance is the date of acceptance.
(c) drug supervision and management departments from the date of acceptance of the application within 30 working days, based on "Drug License Regulations," Article 4 and "Medical Device License Regulations," Article 6 of the review of the declaration materials, to make a decision whether to agree with the preparatory work, and notify the applicant in writing. Do not agree with the preparatory work, shall state the reasons, and inform the applicant of the right to apply for administrative reconsideration or administrative litigation according to law.
(d) the sponsor to complete the preparatory work, to accept the application of drug supervision and management department to submit an application for acceptance, and submit the following materials:
1. "Drug License" application form;
2. "Medical Devices License" application form;
3. Industrial and commercial administration department issued by the proposed pre-approval of the enterprise documents;
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4. Proposed business organization;
5. Proposed business registered address, warehouse address location map, floor plan (indicating the area, functional layout), proof of property rights (or lease agreement) copy;
6. According to the qualification of professional and technical personnel recognized by the qualification certificate and letter of appointment;
7. Proposed quality management documents and storage facilities, equipment catalogs Management documents and warehousing facilities, equipment catalog;
8. Proposed business scope.
(E) acceptance of the application of drug supervision and management department within 30 working days from the date of receipt of the application for acceptance, based on the "opening of in vitro diagnostic reagents business enterprises (wholesale) acceptance criteria" organization acceptance, to make whether to issue the "drug business license" and "medical device business license" decision. Qualified, and issued the "Drug License" and "Medical Device Business License"; does not meet the conditions, shall notify the applicant in writing and explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or administrative litigation in accordance with the law.
(F) After obtaining the "Drug Business License", the applicant shall, in accordance with Article 13 of the "Regulations for the Implementation of the Drug Administration Law", apply to the licensing department for certification of the "Good Manufacturing Practice for Pharmaceutical Products" within a specified period of time. The licensing department shall, in accordance with the "Drug Administration Law Enforcement Regulations," Article XIII of the provisions of the organization of its certification, certification of qualified, issued by the "Drug Certification Practice" certification; certification of unqualified, in accordance with the provisions of the relevant certification management.
Subject: in vitro diagnostic reagents operating standards forwarding notice
Copy: State Food and Drug Administration
Henan Food and Drug Administration issued on July 5, 2007