Starting the second class, the third class of medical equipment manufacturers
Two, the license based on:
"Supervision and Administration of Medical Devices Regulations", "supervision and management of medical equipment manufacturers", "Shandong Province, the supervision and management of medical equipment manufacturers to implement the rules"
Three, acceptance of the scope of:
in the Shandong Province, the opening of the second class, the third class of medical device manufacturers
Four, licensing conditions:
(a) the enterprise has a reasonable organizational structure, clear responsibilities and authorities, and has the appropriate human resources.
(B) the enterprise's legal representative and other senior management personnel familiar with the national supervision and management of medical devices, rules and regulations, as well as the province's management of medical devices. The person in charge of technology and quality has a college degree or above or an intermediate title or above related to the specialty of the products to be produced.
The proportion of staff with junior college education or above and with junior title or above in the enterprise is not less than 20% of the total number of employees.
(C) the enterprise shall set up a specialized quality inspection agency, and have the following conditions:
1, the person in charge of the proposed production of products related to the profession of tertiary education or intermediate title or above;
2, to be equipped with the relevant professional trained quality inspection personnel;
3, with the appropriate place;
4, equipped with the corresponding Factory inspection equipment;
5, the development of perfect raw materials (parts) factory acceptance, product inspection regulations documents.
(D) with the production of products and scale of office, production, storage space and environment.
(e) the development of process documents that can meet the requirements of the product production process (except for processes completed by the subcontractor), and equipped with production equipment appropriate to it.
(vi) Collecting and preserving laws, rules and regulations related to the production and operation of the enterprise as well as technical standards at all levels related to the products produced.
(vii) save product drawings in line with national standards.
(viii) the proposed production of sterile medical devices, must have a production site in line with the "production of sterile medical devices management norms"
Starting the production of Class III medical devices must be a legal entity, the conditions for its start-up in addition to having the production of Class II products the conditions set out by the enterprise, it must have the following conditions at the same time:
1, with a product related to production Professional title of intermediate or higher full-time engineers and technicians not less than two;
2, trained full-time inspectors not less than two.
V. Reporting materials:
"Shandong Province Medical Device Manufacturer License Application Form" (see Annex II), while reporting the following information:
(a) a copy of the qualification certificates of the enterprise personnel (title certificates, graduation certificates, certificates of internal auditors);
(b) national standards of the products to be produced, industry standards, or by the preliminary examination of the medical device registered product standards;
(iii) business license or a copy of the pre-approval notice of the enterprise name;
(iv) the production process of the environment may cause pollution, should provide proof of environmental protection departments.
VI. Procedures:
Provincial bureau acceptance - preliminary examination of materials - on-site review (two types of enterprises entrusted to the municipal bureau of the review, three types of enterprises, the provincial bureau of the organization of review) -
Shandong Province Food and Drug Administration Supervision Office 8562101
Administrative Effectiveness Complaints Center 6912345
One, the license project:
Medical device manufacturers change
Two, the license based on:
"Medical Device Supervision and Administration Regulations", "supervision and management of medical equipment manufacturers," "the Shandong Province Medical Device Manufacturing Enterprise Supervision and Management Measures Implementation Rules"
Three, the scope of acceptance:
Change of enterprise name, registered address, production address, legal representative, person in charge, product range, etc.
Four, licensing conditions:
With the "Medical Device Manufacturing Enterprise License" of the enterprise to apply for the application of the
Five, the declaration of information:
"Shandong Province Medical Device Manufacturing Enterprise License Change Application Form", while declaring the following information:
(1) a new business license or approval notice of change of enterprise name, approval documents of the higher authorities or board of directors' resolution (change of enterprise name applies);
(2) a new business license or approval documents of the higher authorities or board of directors' resolution (change of enterprise) Legal representative and person in charge applies);
3) proposed to increase the national standards of the product, industry standards or by the preliminary examination of the medical device registered product standards (increase the scope of products applies).
VI. Procedures:
Provincial bureau acceptance - preliminary examination of materials - on-site review (increase/change of production address, increase the range of products) Provincial Bureau to decide whether to change
seven, processing time limit:
thirty working days
eight, acceptance of the location:
Provincial Food and Drug Administration Administrative License for the Office of the Department of
nine, the contractor:
Medical Devices Division
ten, complaints Tel:
Shandong Province, Shandong Province, Food and Drug Administration Supervision Office 8562101
Shandong Food and Drug Administration Drug Administration Supervision Office 8562101
Administrative Effectiveness Complaint Center 6912345