China

Trade between Germany and China has been growing continuously over the past years. In 2019, China was Germany's most important trading partner for the third consecutive year with a total trade volume of 199.3 billion euros. Traded goods – mostly from high-tech and innovative sectors – include motor vehicles and components, machinery, electrical engineering, consumer and chemical products as well as IT and communications goods.

 

Since 2008, Germany and China have been working together closely to increase product safety in both countries and to promote the development of a bilaterally and internationally coordinated quality infrastructure dialogue.

 

This goal was reaffirmed in 2019 with a Joint Declaration between the German Federal Ministry of Economics and Energy (BMWi) and the Chinese State Administration for Market Regulation (SAMR). It serves as the foundation for continued cooperation on quality infrastructure in the Sino-German Working Group Product Safety and the Sino-German Working Group Accreditation and Conformity Assessment, as well as the Sino-German Standardisation Cooperation Commission (SGSCC).

 

The political dialogue mechanisms involve relevant ministries, regulators, public agencies, accreditation and standardisation bodies, industry associations and corporations from both countries. On the Chinese side, additional political partners include the SAMR sub-agencies Standardization Administration of China (SAC) and China National Certification and Accreditation Administration (CNCA) as well as the Ministry of Foreign Trade and Economic Cooperation (MOFCOM) and the Cyperspace Administration of China (CAC).

 

The Chinese and German partners and stakeholders address market access concerns of the industry, and thereby improve business conditions and bilateral trade. Topics range from Industrie 4.0, machinery safety, medical devices, e-commerce and electro mobility to cyber security, IT security and data protection.

News

The white paper sheds light on the common Sino-German view on functional safety issues in the Industrie 4.0/Intelligent Manufacturing environment. It explains the basic concept of traditional technical safety, which used to be based on mechanical and electronic technology. The paper elaborates on the rising complexity and interconnection among systems, outlining how the overall infrastructure has become more susceptible to internal failures and cyberattacks. To this extent, the paper analyses existing standards, specifications and provides recommendations to achieve safety for Industrie 4.0/Intelligent Manufacturing. It concludes that existing international standards need to be interpreted and amended to cover new issues and hazards. It also refers to the potential integration of safety and security.

In business with China, divergent standards, double certification requirements and unclear regulatory procedures often pose major obstacles for companies. As a result of the Corona Pandemic, regulatory changes are often approved in a hurry, especially in the field of medical protective equipment. For foreign companies, these changes are often difficult to understand. With the online exchange "Regulatory challenges in doing business with China" in cooperation with the OAV, the team of the Global Project Quality Infrastructure (GPQI) presented current regulatory changes as well as GPQI support offers to the participants.

Events

Currently there are no events.

Contact

Jan-Patrick Schnell

Head of Country Component China
Sino-German Quality Infrastructure Project

 

Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) GmbH
Tayuan Diplomatic Office Building
Room 1-13-1
No. 14, Liangmahe Nanlu, Chaoyang District
100600 Beijing, PR China
北京市朝阳区亮马河南路14号
塔园外交人员办公楼1-13-1

 

Phone: +86 10 85 32 47 58
Mail: china@gpqi.org

Documents

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.

 

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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.

 

 

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Factsheets

GPQI Supports German and Chinese authorities to ensure product quality of personal protective equipment and critical medical supplies for COVID-19 response.

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Studies

The white paper sheds light on the common Sino-German view on functional safety issues in the Industrie 4.0/Intelligent Manufacturing environment. It explains the basic concept of traditional technical safety, which used to be based on mechanical and electronic technology.

Read more …

Recent years have witnessed robust growth of cross-border e-commerce in China. According to the China E-Commerce Report published by the Ministry of Commerce, the cross-border e-commerce growth rate has accelerated since Alibaba’s initial public offering in the United States of America at the end of 2014, to an annual growth rate of 30%.

 

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