Application conditions:
1, the enterprise's production, quality and technical personnel should have with the production of medical devices compatible with the professional ability, and master the national supervision and management of medical devices and the supervision and management of laws, rules and regulations, as well as related product quality, technology, quality of the person in charge shall not be concurrently in charge of the production;
2, the enterprise above junior title or technical personnel with secondary education or more than the proportion of the total number of employees should be compatible with the requirements of the products produced
3, the enterprise should have with the products produced and the scale of production and production equipment, production, warehousing sites and the environment. Enterprises producing medical devices have special requirements for the environment and equipment, etc., should be in line with national standards, industry standards and relevant state regulations;
4, the enterprise should set up a quality inspection organization, and have with the production of varieties and production scale of the quality inspection capacity;
5, the enterprise should be preserved with the production and operation of medical devices related to the laws, rules and regulations and the related 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 producers, 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 opening 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 opening 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" provisions;
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 the 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, responsible person for 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 a copy;
Data No. 4, the production site documents, including proof of real estate or lease agreement and a copy of the lessor's real estate certificate; the general layout of the plant, the main production workshop layout 1, there are clean requirements of the workshop, the function of the room must be marked and the flow of people to the direction of the flow of people; the "second class 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 registration form 1; the relevant personnel registration form 1 (in the application form area download) 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 major production equipment and testing instruments;
Data No. 8, production quality management standardized document directory 1, including purchasing, acceptance, the production process, product testing, warehousing, storage, quality tracking, user feedback, monitoring of adverse events and quality incident reporting system. 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 process equipment, personnel and process parameters control instructions;
Data No. 10, the production process has purification requirements should be provided to the provincial food and drug supervision and management authorities accredited testing organizations (such as: Guangdong Provincial Medical Device Quality Supervision and Inspection Institute, Guangdong Provincial Drug Inspection Institute, etc.) issued within one year a copy of the environmental test 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 the opening of medical device manufacturing enterprises to confirm self-examination of 1.
Application for production license process
(A) Application and acceptance
1. Enterprises producing products listed in the directory, to its location of the provincial Bureau of Quality and Technical Supervision to apply, and submit the following application materials:
1) "National Industrial Products Production License Application" in triplicate;
2) three copies of the business license;
3) three copies of the production license certificate (production license expiration of the re-application of the enterprise);
4) other materials required in the product implementation rules.
2. Provincial Quality and Technical Supervision received an application for business, the application materials meet the requirements of the implementing rules, allowed to accept, and from the date of receipt of the application within 5 days of the date of receipt of the application to the enterprise to send "administrative license application acceptance of the decision";
The application materials do not meet the requirements of the implementing rules and can be corrected to meet the requirements, it should be on the spot or within 5 days of the enterprise to send a "notice of administrative license application materials correction". Administrative License Application Materials Correction Notice" one-time notice. Late notification, since the date of receipt of the application materials is accepted;
The application materials do not meet the "Administrative Licensing Law" and "Regulations on the Administration of Industrial Production Licenses" requirements, should be made inadmissible decisions and issued "administrative license application inadmissible decision".
3. Implementing rules for the review of the Department responsible for organizing the review, the provincial licensing office from the date of acceptance of the enterprise application within five days of the date of all the application materials will be sent to the Department of the review.
(B) enterprise field verification
1. According to the product implementation rules, the provincial quality and technical supervision or review of the Department of organizational review.
2. By the provincial licensing office or review of the Department of the development of enterprise field verification plan, 5 days in advance to inform the enterprise, organized by the Department of the review of the review, the review of the Department at the same time the verification plan copied to the location of the provincial licensing office.
3. Provincial licensing office or review department assigned two to four reviewers to form a review team, the enterprise field verification, the enterprise should cooperate.
4. Review team in accordance with the requirements of the product implementation rules, the enterprise field verification, verification time is generally 1-3 days. The review team is responsible for the results of the field verification of enterprises, and the implementation of the system of responsibility of the team leader.
5. by the provincial quality and technical supervision is responsible for organizing the review, the provincial licensing office from the date of acceptance of the enterprise application within 30 days from the date of completion of the field verification of the enterprise and sampling and sealing of samples, and will be field verification of the conclusions of the verification of the enterprise in writing to inform the verified;
by the Department of the Review of the review of the Department of the review of the application from the date of acceptance of 30 days from the date of completion of the field verification of enterprises Within 30 days from the date of acceptance of the application, the Review Department will complete the field verification of the enterprise and draw and seal the samples, and inform the verified enterprise in writing of the conclusions of the field verification, and inform the provincial licensing office.
6. Enterprises failing the field verification is judged to be unqualified for the enterprise review, the provincial licensing office or review the Department of written report to the State General Administration of Quality Supervision, Inspection and Quarantine, and by the State Administration of Quality Supervision, Inspection and Quarantine of the enterprise issued a "non-administrative licensing decision".
(C) product sampling and inspection
1. field verification of qualified enterprises, the review team in accordance with the requirements of the implementing rules to seal the samples, and inform the enterprise of all the tasks undertaken by the product license inspection of the inspection task of the list of inspection agencies and contact information by the enterprise's own choice.
2. Qualified by the field verification, the need to send samples for testing, inform the enterprise in the sealed samples within 7 days from the date of the sample will be sent to the inspection agency. The need for on-site inspection, by the verifier to notify the enterprise to independently select the inspection agency for on-site inspection.
3. The inspection agency in the product implementation rules within the time limit to complete the inspection work, and issue the inspection report.
4. Enterprise product testing failed to be judged as a business review failed by the review of the Department of written report to the AQSIQ, and the State Administration of Quality Supervision, Inspection and Quarantine to the enterprise issued by the "decision not to administrative licensing.
(D) validation and licensing
1. by the provincial licensing office is responsible for organizing the review, the provincial licensing office in accordance with the relevant provisions of the enterprise's application, business license, verification records, verification reports and product inspection reports and other materials to be summarized and audited, and from the date of acceptance of the application of the enterprise within 30 days of the date of the declaration of the materials sent to the Department of Review;
by the Department of Review Review Department is responsible for organizing the review, the Review Department in accordance with the relevant provisions of the enterprise's application, business license, verification records, verification reports and product inspection reports and other materials for summary and review.
2. The Department of Review from the date of acceptance of the enterprise application within 40 days of the date of the declaration materials will be sent to the National Licensing Review Center.
3. The National License Review Center completes the review of the reported materials within 50 days from the date of acceptance of the enterprise application and reports to the National License Office.
4. AQSIQ will make a decision on whether to grant the license within 60 days from the date of accepting the application. Meet the licensing conditions, AQSIQ shall issue a production license within 10 days from the date of the licensing decision; does not meet the licensing conditions, should be issued within 10 days from the date of the decision to the enterprise "not administrative licensing decision.
5. The National Licensing Office will be licensed enterprise list to the community by the network, newspapers and other means.
(E) production license group companies
1. Group companies and their subsidiaries, branches or production bases (hereinafter collectively referred to as the affiliated units) with legal personality, you can apply for a separate production license; does not have legal personality, can not be in the name of the subordinate unit to apply for a separate production license.
2. Each subordinate unit, regardless of whether it has legal personality or not, can apply for production license individually or jointly with the group company.
3. Affiliated units with the group company to apply for a production license, the group company should be the location of the provincial Quality and Technical Supervision to apply. Where required by the provincial licensing office to organize field verification of enterprises, the group company where the provincial licensing office can directly send a review team, can also be entrusted in writing to the branch where the provincial licensing office to organize verification. Group companies where the provincial licensing office is responsible for the above procedures for summary reporting of relevant materials.
4. Other economic associations and affiliated units applying for production licenses, with reference to the Group's licensing procedures.
(F) commissioned the processing of the record procedures
1. Commissioned enterprises to apply for the record should meet the following conditions:
(1) to obtain a valid business license issued by the Administration for Industry and Commerce, the scope of business should be covered by the application for commissioned the processing of the record of the product;
(2) application for commissioned the processing of the record of the product involves industrial policy, should be in line with industrial policy Relevant requirements;
(3) has signed a valid contract for commissioned processing and notarized, and commissioned the processing contract must be clear that the commissioned enterprise is responsible for all product sales.
2. Entrusted enterprises to apply for the record should meet the following conditions:
(1) to obtain a valid business license issued by the administrative department for industry and commerce, the scope of business should be covered by the application for entrusted processing of the product for the record;
(2) has obtained a production license;
(3) has signed a valid commissioned contract and notarization of the commissioned contract must be responsible for all product sales;
(3) commissioned enterprises to sign a valid contract and notarization of the commissioned contract. Clearly commissioned by the enterprise is responsible for all product sales.
3. The commissioning enterprise and the commissioned enterprise to its local provincial licensing office to file an application, and submit the following application materials for filing:
(1) "National Industrial Products Production License Commissioned Processing Filing Application" in duplicate;
(2) commissioning enterprise and commissioned enterprise copy of business license;
(3) production license of the commissioned enterprise copy;
(3) the production license of the commissioned enterprise. A copy of the production license of the commissioned enterprise;
(4) A notarized copy of the commissioned processing contract.
4. The provincial licensing office shall, within 5 days from the date of receipt of the commissioned processing application for the record, carry out the necessary verification, and record the enterprises that meet the conditions. For those who do not meet the conditions, not for the record and explain the reasons.