Basic Information on the Document
On December 4, 2023, the National Medical Products Administration issued the revised Good Supply Practice for Medical Device Distribution (Medical Device GSP) in 2023 Announcement No. 153, effective July 1, 2024. The 2014 Announcement No. 58 of the former China Food and Drug Administration (the 2014 version of the Practice) was repealed at the same time.
Scale and Structure of the Practice
The new version of the Practice expands from the original 9 chapters and 66 articles to 10 chapters and 116 articles, covering whole-process requirements including the quality management system, personnel qualifications, facilities and equipment, procurement and acceptance, storage and maintenance, sale and transportation, after-sales service, adverse events, and recalls.
Main Highlights of the Revision
The new version of the Practice adds or strengthens the following: clarifying the application requirements for Unique Device Identification (UDI) in product acceptance, outbound re-checking, and computer systems; recognizing that electronic certificates and paper certificates have equal legal effect; adding quality management provisions for automatic device vending machines; refining the quality responsibilities for multi-warehouse coordinated management and direct purchase-and-sale of products; and supplementing management requirements for products sold after clinical confirmation.
Applicable Entities
The Practice applies to enterprises engaged in medical device distribution activities within the territory of the People's Republic of China (including enterprises with concurrent operations), as well as enterprises providing storage and transportation services for medical devices.
Source: National Medical Products Administration, Announcement on Issuing the Good Supply Practice for Medical Device Distribution (2023 No. 153), https://www.nmpa.gov.cn/xxgk/fgwj/xzhgfxwj/20231207173141173.html