Advocacy Actions

2019-06-03 > Beijing

Comments to the IMDRF on the Proposed Update to Clinical Evaluation Documents

On 5th April 2019, the International Medical Devices Regulators Forum (IMDRF) has initiated a public consultation on the proposed update to Clinical Evaluation documents.

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2019-05-24 > Beijing

Letter to NIFDC on the Revision of YY 0341-2009

On 24th May, the medical device sector sent a lobby letter to the National Institutes for Food and Drug Control, regarding the revision of YY 0341-2009, General Technical Requirements for Non-active Metallic Surgical Implants for Osteosynthesis.

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2019-05-21 > Beijing

Comments to the European Commission on the Investment Restrictions on the Medical Device Sector in China

On 21st May, the medical sector submitted comments to the European Chamber regarding the investment restrictions on the medical device sector in China.

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2019-05-17 > Beijing

EUCCC Innovation Centre–Dialogue on the Evaluation for Innovative Medical Devices and eRPS Kick-Off

On 17th May 2019, the European Chamber and the Centre for Medical Devices Evaluation (CMDE) of the National Medical Products Administration (NMPA), co-organized the Dialogue on the Evaluation for Innovative Medical Devices and eRPS Kick-off.

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2019-05-13 > Beijing

Contribute to the "Green Book" of Medical Devices in China

Contribute to the "Green Book" of Medical Devices in China

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2019-05-10 > Beijing

Meeting on Imaging Forum and AI Medical Devices Joint Evaluation Mechanism

National Health Commission, International Cooperation Centre, (IHECC) organized a meeting with medical Imaging industry, discussing about the Medical Imaging Forum in August 2019, as well as the AI Medical Devices Joint Evaluation mechanism.

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2019-04-26 > Beijing

a Report on Medical Device Standards was Submitted to NMPA

HCE-COCIR was approached by NMPA for a report on medical device standards. Upon industry experts' advice, a report was submitted to Center for Medical Device Evaluation of NMPA.

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2019-04-26 > Beijing

Submitted Comments to the Centre for Medical Device Evaluation on the draft Criteria for Establishing a Registration Project.

On 12th April 2019, the Centre for Medical Device Evaluation (CMDE) has initiated public consultations on the draft Criteria for Establishing a Registration Project.

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2019-04-24 > Beijing

Preparatory Meeting for the 10th China International Medical Device Regulatory Forum

On the 24th April, the China Center for Food and Drug International Exchange and the Center for Medical Device Evaluation of the National Medical Products Administration held a preparatory meeting for the 10th China International Medical Device Regulatory Forum.

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2019-04-22 > Beijing

Implement smoothly the 1st review meeting with NMPA for a product, which secure the consequence that the European Chamber platform for reviewing innovative medical devices

Implement smoothly the 1st review meeting with NMPA for a product, which secure the consequence that the European Chamber platform for reviewing innovative medical devices.

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