Legal analysis: 1, the first step: upload the electronic version of the material online: log on to the State Drug Administration website - services - online business guide - medical equipment Production and operation license filing - apply for enterprise - the first use of registration - registration is complete, fill out the application form in accordance with the requirements of the - -Upload electronic materials. Successful upload, waiting for the city audit.
2, the second step: log in to the system to see whether the city audit. After passing the audit, you can submit paper materials to the municipal administrative service hall, the municipal office window on-site license issuance.
Legal basis: "supervision and management of the production of medical devices" Article 8 The opening of the second class, the third class of medical device manufacturers, should be located in the provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration to apply for production licenses, and submit the following information:
(a) a copy of the business license;
(b) the applicant company holds the production of medical devices Registration certificate and a copy of the product technical requirements;
(C) legal representative, a copy of the identity of the person in charge of the enterprise;
(D) production, quality and technical personnel in charge of the identity, education, title certificates;
(E) production management, quality inspection positions of practitioners of academic qualifications, titles list;
(F) production sites Documentation, there are special requirements for the production environment should also be submitted to the facilities, environment, copies of documents;
(vii) the main production equipment and inspection equipment directory;
(viii) quality manuals and procedural documents;
(ix) process flow diagrams;
(j) proof of authorization of the operator;
(xi) other supporting information.