If you are in China, you need to apply for the registration of your medical device in accordance with our regulations, and then apply for a medical device manufacturing license from the local drug administration.
If the production site is abroad, you don't need to apply for a medical device manufacturing license, you only need to do a good job of registering the imported medical devices, which can be marketed and sold in China.
The following is the medical device production license and imported medical devices registration of relevant information
Medical device production license
Medical device manufacturer of the first class
Opening the first class of medical device manufacturers, should have with the production of products produced by the production of conditions, and should be in the receipt of business license within 30 days, fill out the "first class of medical device manufacturer registration form", "the first class of medical device manufacturer registration form", and then fill out the "first class of medical device manufacturer registration form". Medical Device Manufacturer Registration Form", to the location of the province, autonomous region, municipality directly under the Central Government (food) drug supervision and management department in writing.
The second class, the third class of medical device manufacturers
(a) the enterprise's production, quality and technical personnel should have the production of medical devices and the production of appropriate professional competence, and to master the national supervision and management of medical devices and medical equipment laws, rules and regulations, as well as related product quality, technical provisions. The person in charge of quality shall not be concurrently responsible for the production;
(2) the enterprise above junior title or technical personnel with secondary education or above as a 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 of 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;
(d) the enterprise should set up a quality inspection organization, and with the production of varieties and production scale of the quality inspection capabilities;
(e) the enterprise should be preserved with the production and operation of medical devices related to the laws, rules and regulations, rules and Relevant technical standards.
The opening of the third class of medical device manufacturers, in addition to the above requirements should be met, should also have the following conditions:
(a) meet the requirements of the quality management system of the internal auditor not less than two;
(b) the relevant professional title above the intermediate level or college degree or above of full-time technical staff not less than two.
Starting the second, third class medical device manufacturer, should fill out the "Medical Device Manufacturer License (start-up) Application Form"
and submit the following materials:
(a) legal representative, the person in charge of the enterprise's basic information and proof of qualifications;
(b) industrial and commercial administration department issued a notice of pre-approval of the name of the proposed enterprise ;
(c) documents proving the production site;
(d) resume, education or title certificates of the person in charge of production, quality and technology of the enterprise; registration form of relevant professional and technical personnel, skilled workers, and indicate the department and position; the ratio of senior, intermediate and junior technical personnel table;
(e) the scope of the proposed production products, varieties, and the relevant product profile
(f) the main production equipment and inspection equipment catalog;
(g) the production of quality management documents catalog;
(h) the production of products to be produced in the process flow diagram, and indicate the main control items and control points;
(ix) the production of sterile medical devices, should provide production environment test report.
The applicant shall be responsible for the authenticity of all contents of its application materials.
Medical device registration
Medical device registration certificate have to prepare what materials or information?
1, first go to your city Food and Drug Administration, get the application form and electronic copy (you can also download from the website). Then prepare the materials according to the following.
Declaration materials (1) "Medical Device Manufacturer License" (start-up) application form;
(2) the legal representative, the person in charge of the enterprise's basic information and proof of qualifications, including proof of identity, proof of academic qualifications, proof of title, a copy of the appointment documents, work resume;
(3) business administration department issued a notice of approval of the enterprise name or Original and copy of business license;
(4) documents proving the production site, including copies of property certificates or lease agreements and property certificates of the leased party, the general layout of the factory, and the layout of the main production workshops. Workshops with clean requirements, must be marked with functional rooms and human flow towards;
(5) the enterprise's production, technology, quality department responsible for the resume, a copy of the certificate of qualifications and titles; relevant professional and technical personnel, skilled workers registration form, a copy of the certificate, and indicate the department and position; the proportion of senior, middle and junior technical personnel table; a copy of the certificate of the internal auditor;
(6) the scope of products to be produced, varieties and related product profile. Product profile at least includes a description of the product's structural composition, principle, intended use and product standards;
(7) the list of major production equipment and inspection instruments;
(8) production quality management standardized documents catalog: including procurement, acceptance, production process, product inspection, warehousing, warehousing, quality tracking, user feedback, adverse event monitoring and quality accident reporting system and other documents, enterprise organization chart;
(9) the production of the product range, variety and related products. Documents, enterprise organization chart;
(9) the process flow diagram of the proposed product, and indicate the main control items and control points. Including critical and special process equipment, personnel and process parameters control instructions;
(10) proposed production of sterile medical devices, need to provide a clean room qualified test report. Recognized by the provincial food and drug supervision and management department of the testing agency issued within one year in line with the "production of sterile medical devices management standards" (YY0033) qualified test report;
(11) application materials for the authenticity of the self-assurance statement. Listed in the declaration materials catalog, and the material to make a commitment to bear legal responsibility if false. 2, followed by your product needs to have a class I medical device registration certificate:
Class I medical device registration application materials
(a) the territory of the application form for registration of medical devices;
(b) proof of qualification of medical device manufacturers: a copy of the business license;
(c) the applicable product standards and descriptions:
Adoption of national standards, Industry standards as the applicable standards for products, should be submitted to the adopted national standards, industry standards of the text; registered product standards should be signed by the manufacturer.
The manufacturer shall provide the statement that the product applied for complies with the national standards and industry standards, the statement that the manufacturer assumes the responsibility for the quality of the product after it is marketed as well as the description of the relevant product model and specification division.
Here the "seal" means: the enterprise seal, or its legal representative, the person in charge of the signature and enterprise seal (the following medical devices, the same meaning);
(d) the full performance of the product test report;
(e) the enterprise's production of the product's existing resources and quality management capabilities (including testing methods). Management capabilities (including testing methods) of the description;
(F) medical device instructions;
(VII) submitted by the authenticity of the self-assurance statement: should include a list of materials submitted, the production company to assume legal responsibility for the commitment. 3, the Technical Supervision Bureau to apply for testing
Handling
Related documents are & lt; medical device registration management methods & gt;, which provides detailed
Article 5 of the domestic enterprises for the registration of the production of Class I medical devices, should be submitted to the following materials:
(a) proof of qualification of medical device manufacturers.
(2) registered product standards and preparation instructions.
(C) product full performance self-test report.
(D) enterprise product production of existing resource conditions and quality management capabilities (including testing methods) description.
(E) product instructions.
(F) the authenticity of the materials submitted to the self-assurance statement.
Article VI of the domestic enterprises to produce the second class, the third class of medical devices shall submit the following materials for registration of trial production:
(a) medical device manufacturer qualification certificate.
(2) Product technical report.
(C) safety risk analysis report.
(D) Registered product standards and preparation instructions.
(E) product performance self-test report.
(F) State Drug Administration-recognized medical device quality testing organizations within the past year (biological materials for clinical trials within six months before) issued by the product trial production registration type test report.
(VII) more than two clinical trial base clinical trial report. The report provides the implementation of the "medical device registration clinical trial report sub-provisions" (see Annex), clinical trials to implement the "Medical Device Product Clinical Trial Management Measures".
(H) product instructions.
(ix) the submitted material authenticity of the self-assurance statement.
Article VII of the domestic enterprises to produce the second class, the third class of medical devices shall be submitted to the prospective registration of the following materials:
(a) medical device manufacturer qualification certificate.
(2) A copy of the trial production registration certificate.
(C) registered product standards.
(D) product improvement report during trial production.
(E) enterprise quality system assessment (certification) of effective documents.
(F) the State Drug Administration recognized medical device quality testing organizations within the past year issued by the product type test report for registration.
(VII) product quality tracking report.
(viii) submitted by the authenticity of the self-assurance statement.
Notes
Application materials (a) product testing standards The above (1), (2) is in the Food and Drug Administration Medical Devices Division (3) is in the Municipal Technical Supervision Bureau for the