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In order to strengthen the supervision of medical device production and ensure the safety and effectiveness of medical devices, in accordance with the relevant provisions of the "Regulations on the Supervision and Administration of Medical Devices" and "Measures for the Supervision and Administration of Medical Device Production", the State Food and Drug Administration has recently revised and issued the "Annual Self-inspection of the Medical Device Quality Management System".
Report Compilation Guidelines, Catalogue of Prohibited Entrusted Production of Medical Devices, and the Guidelines for Compilation of Quality Agreements for Entrusted Production of Medical Devices
"Guidelines for Compilation of Annual Self-inspection Reports of Medical Device Quality Management System" is based on the "Notice on Issuing Guidelines for Compilation of Annual Self-inspection Reports of Medical Device Manufacturers' Quality Management System" (former State Food and Drug Administration No.
76 [2016]) It has been revised, the main contents are as follows: First, fully implement the latest requirements of the "Regulations on the Supervision and Administration of Medical Devices" and "Measures for the Supervision and Administration of Medical Device Production".
The annual self-examination report supplements and improves the relevant requirements
The "Catalogue of Medical Devices Prohibited from Entrusted Production" is revised on the basis of the "Notice on Issuing the Catalogue of Medical Devices Prohibited from Entrusted Production" (former State Food and Drug Administration, No.
18, 2014)
At the same time, in order to guide the medical device registrant filer and the entrusted manufacturer to do a good job of medical device production quality management, combined with the full implementation of the medical device registrant filer system, the "Guidelines for the Compilation of the Medical Device Entrusted Production Quality Agreement" has been formulated and released
.
This guideline provides guidance for medical device registrants to sign quality agreements with entrusted manufacturing enterprises that meet the corresponding conditions.
It reflects the main characteristics of three aspects: First, it focuses on comprehensiveness
Source: State Food and Drug Administration official website
Text editor: Yu Rujin
Format editor: Yu Chenglin
