Advocacy Actions

2018-12-29 > Beijing

Comments to the CDR’s “Guideline for the Formatting of the Regular Risk Assessment Report by the Medical Devices (MAH)”

On 27 November 2018, the Centre for Drug Re-evaluation has initiated a public consultation on “Guideline for the Formatting of the Regular Risk Assessment Report by the Medical Devices (MAH)”.

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2018-12-29 > Beijing

Meeting with the Center for Drug Re-evaluation for implementing Order#1 of SAMR

The Healthcare Equipment (HCE) Working Group and European Coordination Committee of the Radiological, Electromedical And Healthcare IT Industry (COCIR) visited the Center for Drugs (Medical Devices) Re-evaluation (CDR) of National Medical Products Administration (NMPA) on 29th December 2018.

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2018-12-28 > Beijing

Comments to the CDR’s “Guideline for the Re-evaluation of Medical Devices”

On 27 November 2018, the Centre for Drug Re-evaluation has initiated a public consultation on “Guideline for the Re-evaluation of Medical Devices”.

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2018-12-27 > Beijing

Comments to the CDR’s “Guideline for the Risk Assessment by the Medical Device Market Authorisation Holder (MAH)”

On 27 November 2018, the Centre for Drug Re-evaluation has initiated a public consultation on “Guideline for the Risk Assessment by the Medical Device Market Authorisation Holder (MAH)”.

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2018-12-27 > Beijing

Comments to Ministry of Public Security (MPS) on Draft Guidelines on Internet Personal Information Security Protection

The European Chamber's ICT and Cybersecurity Working Groups submitted comments to the MPS on the draft Guidelines on Internet Personal Information Security Protection, calling for clarification on its nature and effectiveness, as well as on how it will relate to other personal information security standards already in place. The European Chamber also discourages the practice of mandating the level three classified cybersecurity protection requirements for all Internet companies/personal information holders.

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2018-12-27 > Beijing

Comments to Ministry of Industry and Information Technology (MIIT) on Draft Catalogue and Technical Requirements for Micro-power Short-range Radio Devices

The European Chamber's ICT Working Group submitted comments to the MIIT on the draft Catalogue and Technical Requirements for Micro-power Short-range Radio Devices, calling for the MIIT to clarify certain practical aspects after the exemption of such devices from type approval.

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2018-12-21 > All chapters

Meeting with General Operation Department of General Administration of Customs in China (GACC)

Director General of the General Operation Department, Jin Hai of General Administration of Customs in China (GACC) introduced the newly merged organization and the GACC's reform achievements in 2018. GACC representatives from the General Operation Department, Customs Control Department, Enterprise Management Department, Supervision and Internal Auditing Department, and Import and Export Food Safety Bureau also attended the meeting and answered Chamber representatives' questions.

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2018-12-20 > Beijing, Shanghai

Joint Automotive & Auto Components Working Group Meeting with Ministry of Industry and Information Technology (MIIT) Equipment Industry Development Center (EIDC)

The European Chamber's Automotive and Auto Components Working Groups invited the Ministry of Industry and Information Technology (MIIT) Equipment Industry Development Centre (EIDC) to interpret the final version of the Administrative Measures on Market Access Permission for Road Motor Vehicle Manufacturers and Products, which was released by the MIIT on 6 December 2018 and will become effective on 1 June 2019.

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2018-12-20 > Beijing

Meeting with Civil Aviation Administration of China (CAAC) and Position Paper 2018/2019 Presentation

On 20th December 2018, a delegation led by European Chamber Vice President Michael Chang visited the Civil Aviation Administration of China (CAAC), and was received by Deputy Administrator Wang Zhiqing.

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2018-12-20 > Beijing, Shenyang

Seminar on the 'Guideline for Evaluating the Risk-Benefit Ratio of Medical Devices'

The Healthcare Equipment (HCE) Working Group participated in a Seminar on the ''Guideline for Evaluating the Risk-Benefit Ratio of Medical Devices'

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