I, "Medical Device Manufacturer License" reporting procedures:
1, the Provincial Bureau of Pharmaceutical Supervision of medical device manufacturers to carry out inspections, including personnel, production sites, inspection rooms, warehouses, etc., to check the production of technical and quality inspection personnel, production sites and the environment, production equipment, testing equipment, quality management and other qualifications.
2, the application cycle: about 2 months from the production site construction can be completed after passing.
Two, "Class II medical device product registration certificate" reporting procedures:
1, the conditions for applying for Class II medical device product registration certificate:
① Declaration of registration of the product has been included in the "Classification of Medical Devices Catalog" (or in line with the definition of medical devices, classified as Class II products).
② The applicant should obtain a device manufacturer's license and business license, and the product should be applied for in the production of enterprise license approved within the scope of production.
2, apply for Class II medical device product registration certificate procedures:
① Determine the product formula, the formula of the raw materials and auxiliary materials must be in the classification of Class II products in the directory;
② Determine the scope of application, applicable to the surface of the skin or mucous membranes of the auxiliary treatment;
③ review of the quality standards;
④ products in the Medical Device Testing Center for Product testing, issued a qualified test report;
⑤ two hospitals for clinical trials, 30 cases each, two *** 60 cases, issued a clinical report;
⑥ collated declaration information, reported to the provincial bureau.
3, the application cycle: about 4 to 6 months from the start of the product standards review.
Based on the requirements of your company and the information provided, the following is an analysis of the conditions required to apply for the "Medical Device Manufacturer License" for Chitosan Repair Spray (which is a Class II medical device), which are as follows:
I. Requirements for Personnel Qualifications:
1. 1 person in charge of the enterprise and 1 person in charge of the technical personnel, who shall have a college degree or above, or intermediate Above title. (2)
2, in charge of production and quality of the person in charge of each 1, need to have secondary education or junior title, but your company's production products for the sterile products, so the requirements of the education is at least college. (2)
3, there are 2 licensed quality system internal auditor, with ISO9000 and YY/T0287 content of the internal auditor certificate. May participate in the internal auditor training organized by the provincial Drug Administration, 2 to 3 times a year.
4, with the corresponding product full-time inspectors at least 2. (2)
5, the enterprise should occupy the corresponding proportion of the total number of junior title engineers and technicians (accounting for no less than 10% of the total number of employees)
Note: (1) the above personnel shall not be mutually concurrently and need to be familiar with the "Supervision and Administration of Medical Devices Regulations", "supervision and management of the production of medical devices".
(2) The person in charge of each position is required to specialize in a technology similar to that of the products produced by the enterprise.
(3) need to provide the above personnel corresponding education, title certificates, personnel appointment and labor contracts and other supporting documents and personal resume.
Two, site requirements:
1, the overall layout:
(1) the nature of the production site of the enterprise: enterprise management, warehousing and production sites shall not be **** with the need for independent setup. (Provide a lease contract or real estate license and layout)
(2) the production and operation areas should be compatible with the production scale of the area and space for the placement of equipment, appliances, materials, and can be suitable for safe operation.
(3) The production environment should be clean and light appropriate, not crowded.
2, storage site requirements: (ungraded area)
(1) there should be raw materials, packaging materials, packaging materials, labels, finished products, non-conforming goods storage area, the warehouse needs to be closed.
(2) Warehouse requirements for the ground level, easy to ventilate the air, rodent-proof, insect-proof facilities, should be installed with electric fans, exhaust fans, dehumidifiers, screens, mosquito lamps, anti-mouse boards, electronic cats, floor boards and other facilities.
(3) There are special requirements for raw materials should be stored in accordance with the specified conditions, air conditioning should be installed.
3, production workshop requirements: (graded area)
(1) the product is in direct contact with the body for burns, trauma and other sterile products, should be used for aseptic operation or sterilization, and therefore need to comply with the aseptic production workshop procedures. (Set up with reference to the relevant requirements of GMP aseptic pharmaceutical production workshop)
(2) The production process of the workshop includes weighing, mixing, dosing, aseptic filtration, aseptic filling and sealing, inner packaging, outer packaging and other unit operations. (Control area 100,000 level, clean area 10,000 level, critical point 100 level)
Third, regulations and management documents requirements:
Enterprises should collect and save the laws, regulations, rules and relevant technical standards related to the production and operation of medical devices, management documents can be formulated with reference to the standards of the state and related industries. It is sufficient to prepare them according to the verification requirements, and our company is responsible for providing them.
Four, production capacity requirements:
1, the main production of equipment required: dosing tanks, filters, filling machines, sterilization cabinets, packaging machines.
2, commonly used environmental monitoring equipment: anemometer, dust particle counter, temperature and humidity meter, differential pressure meter.
Fifth, the requirements of the inspection capacity:
1, the establishment of quality inspection organizations, and with the production of varieties and production scale appropriate quality inspection capabilities, set up the appropriate inspection equipment.
2, inspector training and make training records.