Selective questions engaged in the third class of medical devices business annual self-inspection report should include at least which content

1. The State Council issued the "General Administration of the Department of Device Supervision on the medical device manufacturers to seek advice on the preparation of the annual self-inspection report of the quality management system guidelines" which include the following aspects:

I. Overview

(a) the basic situation of the production activities

(b) the annual important changes

(c) the implementation of the management commitment

.

II. Annual operation of quality management system

(I) Personnel training and management

(II) Production management and quality control

(III) Changes in product design, changes in production processes

(IV) Purchasing, sales, and after-sales service management

(V) Control of nonconforming products

(VI) Internal auditing and management review

( (F) internal audit and management review

(VII) monitoring of adverse events

three, other matters

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