Advocacy Actions
Meeting with the Centre for Medical Device Evaluation on the Technical Review Guideline for Change of Administrative Licensing Items of In Vitro Diagnostic Reagents (Draft)
On 16th November, the Chamber had a meeting with the Centre for Medical Device Evaluation on the Technical Review Guideline for Change of Administrative Licensing Items of In Vitro Diagnostic Reagents (Draft).
Read moreComments on the NMPA's Public Consultation on the National Medical Device Quality Sampling Inspection Work Procedure (Draft for Comments)
On 12th November, the medical device sector submitted comments on the National Medical Device Quality Sampling Inspection Work Procedure (Draft for Comments) to the National Medical Products Administration.
Read moreAdvocacy Letter on Medical Device Registration Confidentiality Issues
On 06 November, the medical device sector sent an advocacy letter to the National Medical Products Administration on the medical device registration confidentiality issues.
Read morePresident Wuttke Presented Position Paper to Development Research Centre of the State Council (DRC)
A delegation led by President Wuttke, including Shipbuilding Working Group (WG), Pharma WG, HCE WG, Energy WG, Environment WG, Automotive WG, ILS sub WG, and PN Desk held a high-level meeting with Development Research Centre of the State Council to present the Chamber's 2020/2021 Position Paper.
Read moreRoundtable with MOFCOM Official on European Business Operations in China
Roundtable with MOFCOM Official on European Business Operations in China
Read moreMeeting with EUD DG Trade on Challenges for the Medical Device Industry
Shanghai members of the Healthcare Equipment (HCE) Working Group hold a meeting with Mr Ch. Saurenbach, Officer at the Trade Section of the Eurorpean Delegation to China, on challenges for the medical device industry in China.
The member companies reported of their challenges in the highly regulated medical device market, especially for medium-sized companies without large regulatory affairs and government affairs / market access departments.
Registration (market approval) is costly and takes a long time. Though basically Chinese regulations are in line with European ones, details during the registration may be cumbersome.
China has adopted a strict policy of cost-saving in the medical sector, making market access for high-quality European medical devices more difficult.
The homecare market in China is underdeveloped, providing changes in the future, but requiring adaption of the regulatory system, which in the moment puts most resources in large public hospitals.
Meeting with the National Healthcare Security Administration on Procurement of Medical Devices
The Healthcare Equipment Working Group, the American Chamber of Commerce and the Advanced Medical Technology Association met with the National Healthcare Security Administration on Procurement of Disposable Medical Devices and Pharmaceutical Products.
Read moreComments on the CMDE's Public Consultation on the Technical Review Guideline on the Medical Device Cybersecurity (Second Draft)
On 19th October, the medical device sector of the European Chamber sent comments on the Technical Review Guideline on the Medical Device Cybersecurity (Second Draft) to the Centre for Medical Device Evaluation.
Read moreComments to Sichuan HSA's Draft "Plan for Centralised Procurement of Medical Consumables"
The Healthcare Equipment (HCE) Working Group submitted comments to the Sichuan Healthcare Security Administration's (HSA's) draft "Plan for Centralised Procurement of Medical Consumables".
Appreciation Letter to Sichuan Health Authorities for their Contribution to Value-Based Procurement
The Healthcare Equipment (HCE) Working Group sent appreciation letters to the Sichuan Provincial Healthcare Security Administration and the Sichuan Medical Device Clinical Monitoring and Evaluation Centre for their support in promoting value-based procurement of disposable medical devices.
Read more