1, the enterprise's production, quality and technical personnel should have the production of medical devices and the production of appropriate professional competence, and master the national supervision and management of medical devices, laws, rules and regulations, as well as related product quality, technical provisions, the person in charge of quality shall not be concurrently in charge of the production;
2, the enterprise above the junior title or technical personnel above junior secondary education should be appropriate to the requirements of the products being produced. Above the education level of technical personnel in the total number of employees should be appropriate to the requirements of the production of products
3, the enterprise should have with the production of products and production scale of production equipment, production, warehousing sites and the environment. Enterprises producing medical devices have special requirements for the environment and equipment, etc., should be consistent with national standards, industry standards and relevant state regulations;
4, the enterprise should set up a quality inspection organization, and with the production of varieties and production scale of the quality inspection capabilities;
5, the enterprise should be preserved with the production and operation of medical devices related to the laws, rules and regulations and relevant Technical standards;
6, the relevant professional title above the intermediate level or college degree or above full-time technical personnel (the third production enterprises, in vitro diagnostic reagents should be not less than two,);
7, in line with the requirements of the quality management system (ISO13485 training) internal auditors (the third category of manufacturers, the second category of manufacturers, the production of in vitro diagnostic reagents production enterprises at least two, namely 1 management representative, 1 internal auditor)
8, the production of products is the state has issued medical device production quality standards (on the issuance of medical device production quality management standards.doc) (including the production of implementation rules) must comply with its specifications (production implementation rules) requirements.
Such as the start of in vitro diagnostic reagents from the qualification of personnel, site, regulations and quality management documents, production capacity, testing capacity should be in line with the "production of in vitro diagnostic reagents implementation rules (for trial implementation)";
such as the start of one-time use of sterile medical device products (injection, infusion apparatus) from the qualification of personnel, site, regulations and quality management documents, production capacity, Inspection capacity should be consistent with the "one-time use of sterile medical device products (injection, infusion apparatus) production implementation rules;
such as the start of one-time use of anesthesia puncture kits from the qualifications of personnel, site, regulations and quality management documents, production capacity, inspection capacity should be consistent with the "one-time use of anesthesia puncture kits production implementation rules" provisions;
such as the start of surgical implants (Guangdong Food and Drug Administration Measures [2009] No. 51 of the provisions.
Remarks: the production of export glucose test strips, condoms, in accordance with the "on the part of the export of pharmaceuticals and medical devices on the implementation of directory management notice" (Food and Drug Administration Office [2008] No. 168) requirements, should apply for the "Medical Device Manufacturer's License" and the certificate of registration of medical devices.
Applicants submit materials directory:
Data No. 1, "Medical Device Manufacturer License (start-up) Application Form" 3;
Data No. 2, legal representative, the person in charge of the enterprise's identity, proof of academic qualifications or title, a copy of the appointment document and a copy of the work experience;
Data No. 3, the industrial and commercial administration department Issued by the "notice of pre-approval of enterprise name" or "industrial and commercial business license" copy of the original and 1 copy;
Data No. 4, production site documents, including property certificates or lease agreements and a copy of the lessor's property certificates; the general layout of the plant, the main production plant layout 1, there are clean workshop requirements, must be marked with the functional rooms and people flow towards; "the second type of Class II, Class III medical device manufacturers to set up production sites across the province registration form" 4 (to set up production sites across the province of the enterprise applies);
Data No. 5, the enterprise's production, technology, quality department responsible for the curriculum vitae, a copy of proof of academic qualifications or titles; relevant professional and technical personnel, skilled workers, a registration form; the relevant personnel registration form 1 (in the application form area to download) ), and indicate the department and position; 1 copy of the ratio of senior, middle and junior technical personnel; 1 copy of the internal auditor's certificate in line with the requirements of the quality management system;
Data No. 6, the scope of products to be produced, the variety of products and related product profile 1 copy (product profile at least includes the structural composition of the product, the principle of the product, the intended use of the description and product standards); the production of in vitro diagnostic reagents, also need to provide the proposed Reagents, you also need to provide the production of in vitro diagnostic reagents 1 list of enterprises, see Schedule 1;
Data No. 7, a list of the main production equipment and testing instruments;
Data No. 8, a catalog of production and quality management standardized documents, including purchasing, acceptance, the production process, product testing, warehousing, storage, quality tracking, user feedback, monitoring of adverse events and quality incident reporting system and other documents;
Data No. 8, production of quality management standardized document directory, including procurement, acceptance, production process, product testing, storage, quality tracking, user feedback, adverse events monitoring and Quality incident reporting system and other documents;
Data No. 9, 1 copy of the process flow diagram of the product to be produced, and indicate the main control items and control points, including key and special processes, equipment, personnel and process parameters to control the description;
Data No. 10, the production process of the purification requirements should be provided to the provincial food and drug supervision and management authorities recognized by the testing organization (such as: Guangdong Provincial Medical Devices Quality Supervision and Inspection Institute, Guangdong Provincial Drug Inspection Institute, etc.) issued within one year a copy of the environmental testing report (including: a production area purification workshop test report, a 10,000 purification bacteriological inspection room test report).
Such as the proposed production of sterile medical devices, the environment should meet the requirements of YY0033 "sterile medical device production management norms";
Such as the proposed production of in vitro diagnostic reagents, the environment should meet the "in vitro diagnostic reagent production rules (for trial implementation)," the requirements of Appendix A.
Data No. 11, a self-assurance statement of the authenticity of the application materials, including the catalog of application materials and the enterprise to make the material if false to assume legal responsibility for the commitment;
Data No. 12, where the application for the enterprise declaration of the material, the processing personnel is not the legal representative or person in charge of himself, the enterprise should submit a "power of attorney".
Data No. 13, truthfully filled out to start a medical device manufacturing enterprise self-examination confirmation 1.