China - Top Medical Device Alerts

03/31/2023

Notification 2023 No.28, medical device national spot check program was published. Notification 2023 No.28, medical device national spot check program was published, including inspection requirement, reinspection requirement, and other requirement. There are 3 attachments of this notification, including, 1. Spot check program. 2. Reinspection organization list. Reinspection requirement.

03/16/2023

Announcement 2023 No.14, implementation of collateral and particular standards of GB9706.1-2020 GB9706.1-2020 was published on 2020-04-09, and will be effective on 2023-05-01. The announcement includes registration requirement, test requirement, and supervision requirement. Note: If particular standard of specific device has not been published yet, the implementation date of GB9706.1-2020 can be delayed.

03/14/2023

Notification 2023 No.23, working rules of technical committee of medical device classification were published. Notification 2023 No.23, working rules of technical committee of medical device classification were published. The old working rules were modified, and published as attachment of notification

02/08/2023

Annual report(year 2022) of ‘China medical device standards management’ is published. Annual report(year 2022) of ‘China medical device standards management’ is published. The report includes structure and data of China medical device standards.

02/22/2023

Announcement 2023 No. 22, UDI implementation of 3 rd batch of medical devices. Announcement 2023 No. 22, UDI implementation of 3 rd batch of medical devices. The announcement includes scope, agenda, and requirement. 3 rd batch includes 103 kinds of medical devices, product list is provided in attachment. 1 st batch: 2021-1-1 2 nd batch: 2022-6-1 *UDI：Unique Device Identification

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