Required materials are as follows:
One, in Xiaogan City, for example, medical institutions in the arrival of equipment installation, commissioning, acceptance, within one month to submit the following materials to the Equipment Division to apply to do the license:
1, "Class B large-scale medical equipment information registration form" (electronic version);
2, ? The equipment configuration (update) of the approval;
3, "medical institutions license"
4, "medical device registration certificate" and "medical device product registration form"
5, ? Notification of the winning bid
Two, do the certificate: equipment office received the above information to centralize a batch of unified do the certificate.
Third, the medical institutions received the notice of license with all the following license information (otherwise not issued).
1, entrusted to the tender agreement (unit seal)
2, notice of award (unit seal)
3, a copy of the acquisition contract (unit seal)
4, a copy of the invoice (unit seal)
5, a copy of the certificate of acceptance (unit seal)
6, "B large-scale medical equipment information registry " paper (unit seal)
7, updated equipment also need to return the original old certificate (a large and small two certificates)
8, ? Medical institutions to declare no personnel induction qualification information also need to submit the "National Medical Equipment Users Business Ability Assessment Certificate".
Expanded Information:
"The State Council on the revision of & lt; supervision and management of medical devices regulations & gt; decision", Article 34 states: medical equipment use unit configuration of large medical equipment, should be in line with the competent departments to develop the configuration of large medical equipment planning And by the provincial people's government above the competent department of health planning approval, obtain a large equipment configuration license. The configuration of large medical equipment from non-administrative license to administrative license.
In March 2018, with the approval of the State Council, the National Health and Health Commission released the Catalog of Large Medical Equipment Configuration License Administration (2018). The catalog is divided into category A and category B. Among them: category A includes five categories of large medical equipment, for which the NHHC is responsible for configuration licenses, and category B includes seven categories of large medical equipment, for which provincial health administrative departments are responsible for configuration licenses.
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Xiaogan City Health Commission - for - "Class B large medical equipment configuration license" guide?