GB/T 42061-2022
Medical devices—Quality management systems—Requirements for regulatory purposes (English Version)

Standard No.

GB/T 42061-2022

Language

Chinese, Available in English version

Release Date

2022

Published By

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China

Latest

GB/T 42061-2022

Scope

This document specifies quality management system requirements for organizations that need to demonstrate their ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the medical device life cycle, including the design and development, production, storage and distribution, installation or service of medical devices, and the design and development or provision of related activities (such as technical support). This document can also be used by suppliers or external parties providing products (including services related to the quality management system) to such organizations. Unless expressly stated, the requirements of this document apply to organizations of all sizes and types. The requirements in this document that apply to medical devices also apply to related services provided by the organization. For the processes required by this document that apply to the organization but are not implemented by the organization, the organization is responsible for monitoring, maintaining and controlling these processes in the quality management system. If applicable regulatory requirements permit the exclusion of design and development controls, this can be justified for their exclusion from the quality management system. If other methods are required by these regulations, these methods shall be described in the quality management system. It is the organization's responsibility to ensure that any derogation from design and development controls is identified in the statement of conformance to this document. An organization need not include in its quality management system any requirement in Chapters 6, 7 or 8 of this document that is inapplicable due to the activities performed by the organization or the characteristics of the medical devices covered by the quality management system. such a request. For any clause that is determined not to be applicable, the organization records its reasons in accordance with the requirements of 4.2.2.

GB/T 42061-2022 Referenced Document

• GB/T 19000-2016 Quality management systems—Fundamentals and vocabulary

GB/T 42061-2022 history

• 2022 GB/T 42061-2022 Medical devices—Quality management systems—Requirements for regulatory purposes