Category 1 medical device manufacturing enterprise
To open a Category 1 medical device manufacturing enterprise, it must have production conditions suitable for the products it produces, and must wait 30 days after receiving the business license. Within days, fill out the "Registration Form for Class I Medical Device Manufacturers" and notify the (food) drug regulatory authorities in the local province, autonomous region, or municipality directly under the Central Government in writing.
Class II and Class III medical device manufacturing enterprises
(1) The person in charge of production, quality and technology of the enterprise shall have professional capabilities suitable for the medical devices produced, 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 may not
concurrently serve as the person in charge of production;
(2) The proportion of technical personnel with junior professional titles or above or technical secondary school education or above in the enterprise to the total number of employees should be proportional to the number of products produced requirements;
(3) Enterprises should have production equipment, production and storage sites and environments that are suitable for the products they produce and the scale of production. 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 establish quality inspection agencies and have the necessary capabilities to meet the needs of the varieties 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. To open a third-category medical device manufacturing enterprise, in addition to meeting the above requirements, it must also meet the following conditions:
(1) There should be no less than two internal auditors who meet the requirements of the quality management system;
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(2) There should be no less than two full-time technical personnel with intermediate professional titles or above or college degree or above in relevant majors.
To establish a second or third category medical device manufacturing enterprise, one must fill out the "Medical Device Manufacturing Enterprise License (Startup) Application Form"
and submit the following materials:
(1) Basic information and qualification certificates of the legal representative and person in charge of the enterprise;
(2) Pre-approval notice of the name of the proposed enterprise issued by the industrial and commercial administration department;
(3) Documents proving the production site;
(4) Resumes, academic qualifications or professional title certificates of the company’s production, quality and technical leaders; relevant professional technicians and technical workers
Person registration form, indicating the department and position; table of proportions of senior, intermediate and junior technical personnel;
(5) Introduction to the scope, varieties and related products of the products to be produced;
< p>(6) Catalog of main production equipment and inspection equipment;(7) Catalog of production quality management documents;
(8) Process flow chart of the product to be produced, and indicate Main control items and control points;
(9) Those who produce sterile medical devices should provide a production environment test report.
Applicants shall be responsible for the authenticity of all contents of their application materials. Extended information
The "Measures for the Supervision and Administration of the Production of Medical Devices" was reviewed and adopted at the State Food and Drug Administration's executive meeting on June 27, 2014, and the State Food and Drug Administration's Order on July 30, 2014 Announced on the 7th.
Article 7 To engage in the production of medical devices, one must meet the following conditions:
(1) Have production sites, environmental conditions, production equipment and professional technology that are suitable for the medical devices produced personnel;
(2) Have an institution or full-time inspection personnel and inspection equipment to conduct quality inspection of produced medical devices;
(3) Have a management system to ensure the quality of medical devices;
(4) Have after-sales service capabilities suitable for the medical devices produced;
(5) Meet the requirements stipulated in product development and production process documents.
Article 8 To establish a second or third category medical device manufacturing enterprise, it shall apply for a production license to the food and drug regulatory department of the local province, autonomous region, or municipality directly under the Central Government, and submit the following materials:
(1) Copies of business license and organization code certificate;
(2) Copies of the registration certificate and product technical requirements of the medical devices produced by the applying enterprise;
< p>(3) Copies of the identity certificates of the legal representative and the person in charge of the enterprise;(4) Copies of the identity, academic qualifications and professional title certificates of the persons in charge of production, quality and technology;
(5) List of academic qualifications and professional titles of employees in production management and quality inspection positions;
(6) Certification documents for the production site. If there are special production environment requirements, copies of certification documents for the facilities and environment should also be submitted. ;
(7) Catalog of main production equipment and inspection equipment;
(8) Quality manual and procedure documents;
(9) Process flow chart;< /p>
(10) Authorization certificate of the person in charge;
(11) Other supporting materials.
The medical device industry involves many industries such as medicine, machinery, electronics, and plastics. It is a multidisciplinary, knowledge-intensive, and capital-intensive high-tech industry. The basic characteristics of high-tech medical equipment are digitization and computerization. They are the crystallization of multi-disciplinary and cross-field modern high technology. Their products have high technical content and high profits. Therefore, they are the commanding heights of competition between major scientific and technological countries and large international companies. The threshold for intervention is high. Even in sub-sectors with low overall gross profit margins and low investment, products with higher technological content will continue to appear.
Baidu Encyclopedia-Medical Device Production License