YY/T 0287-2017: Medical devices -- Quality management systems -- Requirements for regulatory purposes

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Scope

This Standard specifies requirements for a quality management system where an
organization needs to demonstrate its ability to provide medical devices and related
services that consistently meet customer and applicable regulatory requirements.

Basic Data

Standard ID	YY/T 0287-2017 (YY/T0287-2017)
Description (Translated English)	Medical devices -- Quality management systems -- Requirements for regulatory purposes
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.040.01; 03.120.10
Word Count Estimation	37,361
Date of Issue	2017-01-19
Date of Implementation	2017-05-01
Older Standard (superseded by this standard)	YY/T 0287-2003
Quoted Standard	GB/T 19000-2016
Adopted Standard	ISO 13485-2016, IDT
Regulation (derived from)	Medical Device Industry Standard Announcement No. 11 of 2017
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard applies to organizations of all sizes and types. The requirements applicable to medical devices in this standard apply equally to the services provided by the organization.