Apply for a medical device production license

Application conditions:

1. The person in charge of production, quality and technology of the enterprise should have the qualifications suitable for the medical devices produced. Professional abilities, and master the national laws, regulations and rules on the supervision and management of medical devices as well as relevant product quality and technology regulations. The person in charge of quality shall not concurrently serve as the person in charge of production;

2. Junior or above within the enterprise The proportion of technical personnel with professional titles or technical secondary school education or above to the total number of employees should be consistent with the requirements of the products produced

3. The enterprise should have production equipment that is suitable for the products and production scale, production, Warehousing site and environment. Enterprises that produce medical devices that have special requirements for the environment and equipment should comply with national standards, industry standards and relevant national regulations;

4. Enterprises should set up a quality inspection agency with the necessary capabilities to meet the needs of the varieties and products they produce. Quality inspection capabilities commensurate with the production scale;

5. Enterprises should preserve laws, regulations, rules and relevant technical standards related to the production and operation of medical devices;

6. Relevant majors Full-time technical personnel with intermediate professional titles or above or college degree or above (third-category manufacturing enterprises and in vitro diagnostic reagents should have no less than two,);

7. Internal audit in compliance with quality management system requirements (ISO13485 training) (at least 2 personnel from third-category manufacturing enterprises, second-category manufacturing enterprises, and in vitro diagnostic reagent manufacturing enterprises, namely 1 manager representative and 1 internal auditor)

8. The products produced belong to the national Those that have promulgated the quality management specifications for medical device production (about the issuance of quality management specifications for medical device production.doc) (including production implementation details) must comply with the requirements of its specifications (production implementation details).

For example, an enterprise that develops in vitro diagnostic reagents should comply with the provisions of the "Implementation Rules for the Production of In vitro Diagnostic Reagents (Trial)" in terms of personnel qualifications, site, regulations and quality management documents, production capacity, and testing capabilities;

For example, an enterprise that develops disposable sterile medical device products (infusion and infusion equipment) should comply with the "Disposable Sterile Medical Device Products" in terms of personnel qualifications, site, regulations and quality management documents, production capacity, and inspection capabilities. (Injection and infusion equipment) Production Implementation Rules";

If an enterprise opens a disposable anesthesia puncture kit, its personnel qualifications, site, regulations and quality management documents, production capacity, and inspection capabilities should comply with the " "Implementation Rules for the Production of Disposable Anesthesia Puncture Kits";

For example, companies that develop surgical implants should comply with the "Surgical Implants" in terms of personnel qualifications, sites, regulations and quality management documents, production capabilities, and inspection capabilities. The provisions of the "Implementation Rules for the Production of Customized Dentures";

For example, enterprises that open customized dentures and dentures should comply with the "About Further Improving Customized Dentures" in terms of personnel qualifications, site, regulations and quality management documents, production capacity, and inspection capabilities. Notice on the Issuance and Issuance of Licenses for Denture Manufacturing Enterprises" (Provisions of Guangdong Food and Drug Administration [2009] No. 51.

Note: Enterprises that produce and export glucose test strips and condoms shall, in accordance with the "Regulations on Certain According to the requirements of the "Notice on Matters Relevant to the Implementation Catalog Management of the Production of Exported Drugs and Medical Devices" (Food and Drug Administration [2008] No. 168), you should apply for a "Medical Device Production Enterprise License" and a medical device registration certificate.

List of materials submitted by the applicant:

Document No. 1, 3 copies of "Medical Device Manufacturing Enterprise License (Startup) Application Form";

Document No. 2 , the identity certificate of the legal representative and the person in charge of the enterprise, academic certificate or professional title certificate, a copy of the appointment document and a work resume;

Document No. 3. "Enterprise Name Preliminary Certificate" issued by the industrial and commercial administration department The original and 1 copy of the "Approval Notice" or "Industrial and Commercial Business License";

Document number 4. Production site certification documents, including real estate certificate or lease agreement and a copy of the lessor's real estate certificate 1 1 copy of the general floor plan of the factory and the layout of the main production workshops. Workshops with cleanliness requirements must indicate the functional rooms and the flow of people; "Registration Form for Second and Third Class Medical Device Manufacturing Enterprises to Establish Production Sites across Provinces" 4 (applicable to enterprises planning to set up production sites across provinces);

Document number 5, resume, academic certificate or professional title certificate of the person in charge of the enterprise's production, technology, quality department; 1 copy of relevant professional 1 registration form for technicians and skilled workers; 1 registration list for relevant personnel (download in the application form area), and indicate the department and position; 1 ratio table for senior, middle and junior technical personnel; in line with the requirements of the quality management system 1 copy of the internal auditor's certificate;

Document No. 6, 1 copy each of the scope and variety of the product to be produced, and a brief introduction to related products (the product brief includes at least a description of the product's structural composition, principles, and intended uses) description and product standards); if you plan to produce in vitro diagnostic reagents, you must also provide a list of the companies that plan to produce in vitro diagnostic reagents, see Appendix 1;

Document No. 7, list of main production equipment and testing instruments 1 copy;

Document number 8, 1 copy of production quality management specification document directory, including procurement, acceptance, production process, product inspection, warehousing, outgoing warehouse, quality tracking, user feedback, adverse event monitoring and Quality incident reporting system and other documents;

Document number 9, 1 process flow chart of the product to be produced, and indicate the main control items and control points, including equipment, personnel and process parameters for key and special processes Description of control;

Document No. 10. If the production process has purification requirements, a testing agency recognized by the provincial food and drug supervision and administration department should be provided (such as: Guangdong Provincial Medical Device Quality Supervision and Inspection Institute, Guangdong Provincial Drug Inspection Institute A copy of the environmental testing report issued within one year (including: one testing report for the purification workshop in the production area and one testing report for the 10,000-level purification bacteria testing room).

If the environment is intended to produce sterile medical devices, it should meet the requirements of YY0033 "Manufacturing Regulations for Sterile Medical Devices";

If the environment is intended to produce in vitro diagnostic reagents, it should meet the requirements of " Requirements in Appendix A of the Implementation Rules for the Production of In Vitro Diagnostic Reagents (Trial).

Document No. 11. A self-guarantee statement on the authenticity of the application materials, including a catalog of application materials and the company’s commitment to bear legal responsibility if the materials are false;

Document No. 12 . When applying for enterprise declaration materials, the handling person is not the legal representative or person in charge, and the enterprise shall submit a "Power of Attorney".

Document No. 13. One copy of the self-examination confirmation letter for starting a medical device manufacturing enterprise that has been filled out truthfully.

Process for applying for a production license

(1) Application and acceptance

1. Enterprises producing products listed in the catalog should report to the provincial quality and technical supervision department where they are located Apply to the Bureau and submit the following application materials:

1) "National Industrial Product Production License Application" in triplicate;

2) Three copies of the business license;

3) Three copies of the production license certificate (for enterprises that re-apply after the validity period of the production license expires);

4) Other materials required in the product implementation rules.

2. After receiving the application from the enterprise, the Provincial Quality and Technical Supervision Bureau will accept the application if the application materials meet the requirements of the implementation rules, and will send the "Administrative License" to the enterprise within 5 days from the date of receipt of the enterprise's application. Application Acceptance Decision";

If the application materials do not meet the requirements of these Implementing Rules and can be met through supplementation and correction, a one-time "Notice of Supplementation and Correction of Administrative Licensing Application Materials" shall be sent to the enterprise on the spot or within 5 days. inform. If no notification is made within the time limit, the application will be deemed accepted from the date of receipt of the application materials;

If the application materials do not comply with the requirements of the Administrative Licensing Law and the Regulations on the Administration of Industrial Product Production Licenses, an inappropriate decision shall be made. A decision will be made on the acceptance and a "Decision on Not Accepting the Administrative Licensing Application" will be issued.

3. If the implementation rules stipulate that the examination department is responsible for organizing the examination, the provincial license office shall submit all application materials to the examination department within 5 days from the date of accepting the enterprise's application.

(2) Enterprise on-site inspection

1. According to the requirements of the product implementation rules, the provincial quality and technical supervision bureau or review department shall organize the review.

2. The provincial licensing office or inspection department shall formulate an enterprise on-site inspection plan and notify the enterprise 5 days in advance. If the inspection department organizes the inspection, the inspection department will also send a copy of the inspection plan to the local provincial license. office.

3. The provincial licensing office or inspection department assigns 2 to 4 inspectors to form an inspection team to conduct on-site verification of the enterprise, and the enterprise shall cooperate.

4. The review team conducts on-site verification of the enterprise in accordance with the requirements of the product implementation rules. The verification time is generally 1-3 days. The review team is responsible for the results of the company's on-site verification and implements a team leader responsibility system.

5. If the provincial quality and technical supervision bureau is responsible for organizing the review, the provincial license office will complete on-site verification of the enterprise and seal samples within 30 days from the date of accepting the enterprise's application, and will The verification conclusion shall be notified in writing to the inspected enterprise;

If the inspection is organized by the inspection department, the inspection department will complete the on-site inspection of the enterprise and seal samples within 30 days from the date of accepting the enterprise's application, and send the on-site inspection The verification conclusion shall be notified in writing to the inspected enterprise and to the provincial licensing office.

6. If an enterprise fails to pass the on-site inspection, it will be deemed that the enterprise has failed the examination. The provincial licensing office or review department will report it in writing to the General Administration of Quality Supervision, Inspection and Quarantine, and the General Administration of Quality Supervision, Inspection and Quarantine will issue a " Decision on Not Granting Administrative Licensing".

(3) Product Sampling and Inspection

1. If the enterprise passes the on-site verification, the review team will seal the sample in accordance with the requirements of the implementation rules, and notify all companies responsible for the production license inspection of the product The list of inspection agencies and contact information for the task shall be selected by the enterprise independently.

2. If the on-site inspection is qualified and samples need to be sent for inspection, the enterprise shall be informed to send the samples to the inspection agency within 7 days from the date of sealing the samples. If on-site inspection is required, the inspector shall notify the inspection agency independently selected by the enterprise to conduct on-site inspection.

3. The inspection agency shall complete the inspection work within the time specified in the product implementation rules and issue an inspection report.

4. If the enterprise's product inspection fails, it will be deemed that the enterprise has failed the examination. The examination department will report it in writing to the General Administration of Quality Supervision, Inspection and Quarantine, and the General Administration of Quality Supervision, Inspection and Quarantine will issue a "Decision on Not Granting Administrative Licensing" to the enterprise.

(4) Appraisal and issuance of certificates

1. If the provincial licensing office is responsible for organizing the review, the provincial licensing office shall review the enterprise’s application form and business license in accordance with relevant regulations. , verification records, verification reports, product inspection reports and other materials, and submit the application materials to the review department within 30 days from the date of accepting the enterprise's application;

The review department is responsible for organizing the review, The review department summarizes and reviews the company's application form, business license, verification records, verification reports, product inspection reports and other materials in accordance with relevant regulations.

2. The Examination Department will submit the application materials to the National License Examination Center within 40 days from the date of accepting the enterprise's application.

3. The National License Examination Center will complete the review of the submitted materials within 50 days from the date of accepting the enterprise's application and report it to the National License Office.

4. The General Administration of Quality Supervision, Inspection and Quarantine will make a decision on whether to grant the license within 60 days from the date of accepting the enterprise’s application. If the conditions for issuance of licenses are met, the General Administration of Quality Supervision, Inspection and Quarantine shall issue a production license within 10 days from the date of the licensing decision; if the conditions for issuance of licenses are not met, the General Administration of Quality Supervision, Inspection and Quarantine shall issue a "Decision to Deny Administrative Licensing" to the enterprise within 10 days from the date of the decision. Book".

5. The National Licensing Office will publish the list of certified enterprises to the public through the Internet, newspapers and periodicals.

(5) Production license of group companies

1. If a group company and its subsidiaries, branches or production bases (hereinafter collectively referred to as affiliated units) have legal person status, they can independently Apply for a production license; if you do not have legal person qualifications, you cannot apply for a production license separately in the name of your affiliated unit.

2. Each affiliated unit, regardless of whether it has legal personality or not, can apply for a production license individually or jointly with the group company.

3. When the affiliated unit applies for a production license together with the group company, it shall submit an application to the provincial quality and technical supervision bureau where the group company is located. Where the provincial licensing office organizes an on-site inspection of the enterprise in accordance with regulations, the provincial licensing office where the group company is located can directly send an inspection team, or it can entrust the provincial licensing office where the branch is located to organize the verification in writing. The provincial licensing office where the group company is located is responsible for summarizing and reporting relevant materials in accordance with the above-mentioned procedures.

4. If other economic consortiums and affiliated units apply for production licenses, they shall refer to the group company's license application procedures.

(6) Entrusted processing filing procedures

1. The entrusting enterprise shall meet the following conditions when applying for filing:

(1) Obtain a valid certificate issued by the industrial and commercial administration department Business license, the business scope should cover the products for which entrusted processing and filing are applied for;

(2) If the products for which entrusted processing and filing are applied involve industrial policies, they should comply with the relevant requirements of industrial policies;

(3 ) A valid entrusted processing contract has been signed and notarized, and the entrusted processing contract must clearly entrust the enterprise to be responsible for all product sales.

2. The entrusted enterprise shall meet the following conditions when applying for registration:

(1) Obtain a valid business license issued by the industrial and commercial administration department, and the business scope shall cover the products for which the entrusted processing is applied for registration;

(2) A production license has been obtained;

(3) A valid entrusted processing contract has been signed and notarized, and the entrusted processing contract must clearly entrust the enterprise to be responsible for all product sales.

3. The entrusting enterprise and the entrusted enterprise shall respectively submit filing applications to the provincial licensing offices where they are located, and submit the following filing application materials respectively:

(1) "National Industrial Products Production License Entrusted Processing Registration Application Form" in duplicate;

(2) Copies of the business licenses of the entrusting enterprise and the entrusted enterprise;

(3) The production license of the entrusted enterprise A copy of the certificate;

(4) A notarized copy of the entrusted processing contract.

4. The provincial licensing office shall conduct necessary verification within 5 days from the date of receipt of the entrusted processing registration application, and register the qualified enterprises. Those who do not meet the conditions will not be registered and the reasons will be explained.