1, application: the applicant with the declaration of information to the provincial, autonomous regions, municipalities directly under the Central People's Government Drug Administration to apply;
2, acceptance: the declaration of information submitted to the Food and Drug Administration administrative hall. After examination, the application belongs to the scope of responsibilities of the department, the declaration of information in line with the prescribed requirements, to be accepted, and issued "Notice of Acceptance";
3, review and approval: the declaration of information for the initial examination, in accordance with the "Medical Device Business Qualification Accreditation Rules" organization acceptance;
4, publicity, certification, delivery: administrative licensing decision in the Food and Drug Administration website for publicity. Drug Administration website for publicity, at the same time the system certificate and delivered to the applicant;
5, need to pay attention to the enterprise is to apply for a medical device license for the enterprise's place of operation has certain requirements, the relevant departments of the site requirements are very strict, and even the area of the site has certain requirements, the enterprise must be based on the requirements of the selection of a suitable company registered address, otherwise the relevant ministry, come to the inspection of the When found that the enterprise address is not qualified, it is impossible to issue the enterprise medical equipment business license.
What is the validity period of the class medical device business record certificate?
The validity period of five years, the expiration of the validity of the need to continue the registration, should be valid six months before the expiration of the original registration department to apply for renewal of registration.
What are the materials required for the application of Class II medical device license?
1, a copy of the business license;
2, the legal representative, the person in charge of the enterprise, the person in charge of quality of the identity card, a copy of the certificate of academic qualifications or titles;
3, organization and departmental setup description;
4, the scope of business, the business mode description;
5, the business premises, the warehouse address of the geographic location of the map, Floor plan, documents proving property rights or lease agreement (with documents proving property rights) copies;
6, business facilities, equipment directory;
7, business quality management system, working procedures and other documents directory;
8, computer information management system basic information and functional description;
9, proof of authorization by the operator;
10, application form;
11, other supporting materials.
In summary, class medical device license is to operate the second class of medical devices, business enterprises need to the local food and drug regulatory departments for the record. Enterprises to the drug regulatory department to submit medical device license filing materials. Pharmacovigilance department to review the materials. Enterprises submit materials formally accepted; the relevant departments of administrative review; on-site review; the relevant departments to make administrative decisions; the preparation and issuance of licenses.
Legal basis:
"Medical Device Business License Management Measures" Article VI
Application for "Medical Device Business License" shall have the following conditions:
(a) with the scale and scope of business operations and the quality of the quality management organization or full-time quality management personnel. Quality management personnel should have a nationally recognized relevant professional qualifications or titles;
(ii) with the scale and scope of operation of relatively independent premises;
(iii) with the scale and scope of operation of storage conditions, including storage facilities and equipment in line with the requirements of the characteristics of the medical device products;
(iv) should be Establish and improve product quality management system, including procurement, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking system and adverse event reporting system;
(e) should have the appropriate technical training and after-sales service with its business medical device products, or agreed to provide technical support by a third party.