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Notice on the Release of Guidelines for the Preparation of Special Review Application Materials for Innovative Medical Devices (No. 127, 2018)

Notice on the Release of Guidelines for the Preparation of Special Review Application Materials for Innovative Medical Devices (No. 127, 2018)

In order to implement the Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices (Office Letter [2017] No. 42) issued by the General Office of the CPC Central Committee and the General Office of the State Council, and to further improve the preparation of application materials and technical review of innovative medical devices as stipulated in the Special Review Procedure for Innovative Medical Devices (Announcement No. 83 of the State Food and Drug Administration in 2018), the State Food and Drug Administration has organized the formulation of the Guidelines for the Preparation of Application Materials for Special Review of Innovative Medical Devices, which are hereby promulgated. The Guidelines for the Preparation of Application Materials for Special Review of Innovative Medical Devices (Announcement No. 166 of the State Food and Drug Administration in 2016) issued by the former State Food and Drug Administration are hereby repealed.

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2018

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The State Council's decision to amend the

The State Council's decision to amend the "Medical Device Supervision and Administration Regulations"

The "Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices" is hereby promulgated and shall come into force on the date of promulgation.

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2018

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Announcement of the General Administration on the Regulation of Business Operations in the Field of Medical Device Distribution (No. 112 of 2016)

Announcement of the General Administration on the Regulation of Business Operations in the Field of Medical Device Distribution (No. 112 of 2016)

In order to regulate the circulation of medical devices and crack down on illegal business operations, the State Food and Drug Administration has decided to conduct a centralized rectification of illegal business operations in the field of medical device circulation. 1. From the date of this announcement, all enterprises engaged in the second and third categories of medical devices shall conduct self-inspections on whether their enterprises have the following illegal behaviors:

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2018

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