YY/T 0287-2017Medical devices-Quality management systems- Requirements for regulatory purposes (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

This standard replaces YY/T 0287-2003, Medical devices - Quality management systems - Requirements for regulatory purposes. Compared with YY/T 0287-2003, the main technical changes are as follows:

- the importance of regulatory requirements is emphasized;

- the scope of application is extended;

- the requirements for risk management are strengthened;

- requirements for communication with and reporting to regulatory authorities are added;

- the requirements for post-market supervision are strengthened;

- requirements for documentation and records are added.

This standard uses the translation method to adopt ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes, identically.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing authority shall not be held responsible for identifying any or all such patent rights.

This standard was proposed by the China Food and Drug Administration and is under the jurisdiction of the National Technical Committee on Quality Management and General Requirements for Medical Devices of Standardization Administration of China (SAC/TC 221).

Drafting organization: Beijing Huaguang Certification Co., Ltd. for Medical Devices.

Main drafters: Mi Lanying, Chang Jia, Zheng Yihan, Li Chaohui, Li Xin, Wang Meiying, Chen Zhigang.

The previous editions replaced by this standard are: YY/T 0287-1996 and YY/T 0287-2003.

1 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.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

GB/T 19000-2016, Quality management systems - Fundamentals and vocabulary (ISO 9000:2015, IDT)

3 Terms and definitions

For the purposes of this document, the terms and definitions given in GB/T 19000-2016 and the following apply.

3.3 clinical evaluation: assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer.