The applicant to submit materials catalog:
Data No. 1, "Medical Device Business License Change Application Form", "Medical Device Business License";
Data No. 2, "Medical Device Business License" original and copy of the original;
Data No. 3, a copy of the copy of the business license;
Data No. 4, a copy of the quality manager's ID card, certificate of education or title certificate and resume. In-service in-service certification materials.
Data No. 5, the enterprise to change the content of the situation description;
If the change of quality manager, you need to provide a copy of the proposed quality manager's academic qualifications, title certificates, ID cards and "enterprise quality management personnel resume".
Data No. 6, quality management personnel on duty self-assurance statement; self-assurance statement of the authenticity of the application materials, including the declaration of the material catalog and the enterprise to the material to make a commitment to bear legal responsibility if false;
Data No. 7, where the application for the declaration of the enterprise's materials, the processing staff is not the legal representative or person in charge of the person himself, the enterprise should submit the "letter of authorization".
Expanded Information:
The Ministry of Finance issued the "People's Republic of China*** and the Ministry of Finance Government Procurement Information Bulletin (No. 414)" (hereinafter referred to as the "Bulletin"), which has caused a strong reaction in the medical device industry and government procurement parties. The author believes that the filing should be a necessary condition for operating Class II medical devices.
The Announcement is actually a complaint handling decision on the "China Red Cross Society Career Development Center for the Disabled Elderly Elderly Services Project (nursing beds, caregivers, etc.)".
The main content is as follows:
After examination, the oxygen concentrator belongs to the second class of medical devices. According to the "supervision and management of medical devices regulations" (hereinafter referred to as "regulations"), Article 30 and "supervision and management of medical devices" (hereinafter referred to as "measures"), Article 12, engaged in the operation of the second class of medical devices, by the business enterprise to the municipal people's government of the location of food and drug supervision and management department for the record.
According to this article, the state implements filing management rather than license management for the operation of Class II medical devices, and filing is not a necessary condition for the relevant suppliers to operate Class II medical devices. Even without the record, the supplier can also engage in the operation of second-class medical devices.
Shandong government service network - medical equipment business license (quality responsible person change) service guide
People's Daily Online - filing is a necessary condition for the operation of the second class of medical devices