Dokumente - China

30.09.2019

UDI first-batch implementation

On 17 September 2019, the National Medical Products Administration (NMPA) circulated a call for comments on the “Notice to matters related to the first batch implementation of UDI for medical devices”1. The deadline for comments is 25 September 2019.

Following the publication of the regulations for the UDI-system on 27 August 2019, the draft notice specifies the first step in the step-by-step implementation plan for UDI in China. It includes a product catalogue for the first batch of products requiring UDI, covering certain high-risk, class III devices.

26.09.2019

Rules for UDI in China

On 27 August 2019, the National Medical Products Administration (NMPA) published the Regulations for the Unique Device Identifier (UDI) System for Medical Devices (announced in Circular [2019] No. 66) along with an interpretation. The regulations will enter into force on 1 October 2019, while actual implementation is to take place step-by-step based on risk classifications. More specific information on this step-by-step implementation, however, is still to follow.

26.09.2019

UDI Pilot Implementation in China

On 3 July 2019, the General Office of the National Medical Products Administration (NMPA) and the General Office of the National Health Commission (NHC) announced the initiation of the pilot implementation of a Unique Device Identifier (UDI) System in China.

26.09.2019

New regulations for Adverse Events Reporting for MD in China

On 1 January 2019, new regulations for the adverse events (AE) monitoring and reporting system for medical devices in China have entered into force, replacing the previous rules from 2008.

30.04.2019

Guidance "Use Cases and Applications"

Sub-Working Group Industrie 4.0/Intelligent Manufacturing of the Sino-German Standardisation Cooperation Commission

30.04.2019

Use Case "Equipment Lifecycle Management"

Sub-Working Group Industrie 4.0/Intelligent Manufacturing of the Sino-German Standardisation Cooperation Commission

09.11.2018

Documentation: Sino-German Expert Talks on Quality Infrastructure for a Green Construction Industry

Documentation of the expert talks on the topic "Quality Infrastructure for a Green Construction Industry", which took place on 1 November at the FENESTRATION BAU China 2018 trade fair in Beijing.

18.04.2018

Standardisation Roadmap Predictive Maintenance for Industrie 4.0 / Intelligent Manufacturing

The Standardisation Roadmap of Predictive Maintenance for Sino-German Industrie 4.0 / Intelligent Manufacturing (2.0)

18.04.2018

Alignment Report for Reference Architectural Model for Industrie 4.0 / Intelligent Manufacturing System Architecture

Alignment Report for Reference Architectural Model for Industrie 4.0 / Intelligent Manufacturing System Architecture by the Sino-German Industrie 4.0 / Intelligent Manufacturing Standardisation Sub-Working Group.

18.04.2018

Security Standards White Paper for Sino-German Industrie 4.0 / Intelligent Manufacturing

Security Standards White Paper for Sino-German Industrie 4.0 / Intelligent Manufacturing by the Sino-German Industrie 4.0 / Intelligent Manufacturing Standardisation Sub-Working Group.

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