Advocacy Actions
Feedback submitted for Call for Comments on Fourth Round of Centralised Medical Consumables Procurement in Fujian Province
The Healthcare Equipment Working Group has submitted feedback for the Call for Comments on the Draft on the Fourth Round of Centralised Medical Consumables Procurement in Fujian Province, recommending adjustments to procurement volumes, product catalogues, working processes, and overall supporting policies to ensure the practical implementation of Volume-Based Procurement.
Read moreReport on Efforts by Healthcare Equipment Working Group, CDMD, and COCIR to Address COO Requirements for Registration of Imported Medical Devices in China
Report on Efforts by Healthcare Equipment Working Group, CDMD, and COCIR to Address COO Requirements for Registration of Imported Medical Devices in China. The inclusion of country of origin in the documentation required for registration has resulted in slower approval of imported products in China. The joint efforts of the Healthcare Equipment Working Group, Consumable and Disposable Medical Device Desk (CDMD), and COCIR demonstrate their commitment to advocating for a more streamlined process for the registration of imported medical devices in China. Find out what they discovered in their report.
Read moreSubmission of the Comments on Fourth Batch National Volume-based Procurement of High-Value Medical Consumables Draft
The Healthcare Equipment Working Group submitted comments on the Fourth Batch National Volume-based Procurement of High-Value Medical Consumables draft. They suggested allowing industry enterprises to grow in the centralized procurement of sports medicine products, with tenders awarded to companies that achieve price reductions. It is important to establish clear rules with the involvement of companies and to consider the industry's requirements for innovation and development.
Read moreMeeting with European Commission Trade Counsellor on Healthcare Equipment Working Group Issues
The Healthcare Equipment Working Group met with Helene Juramy, the trade counsellor from the Delegation of the European Commission to discuss public procurement and imported medical devices. Both parties expressed commitment to promoting fair trade practices in the healthcare equipment industry. Learn more about the meeting outcomes.
Read moreComments on the Guidelines for Review of Registration Changes of In Vitro Diagnostic Reagents (Draft for Comments)
The Consumerable and Disposable Medical Device Desk provides feedback on draft guidelines for registration changes of in vitro diagnostic reagents. The guidelines propose adding clauses to prevent repeated applications for the same matter, and may not require a risk analysis report for changes if risks can be directly determined without increased risks.
Read moreCall for Comments on the Measures for the Administration of Advertisement Review of Drugs, Medical Devices, Health Food and Food for Special Medical Purposes (Draft)
On 28th June, the Agriculture, Food and Beverage Working Group, the FSMP Advisory Committe (Sub-working Group), Healthcare Equipment Working Group and Pharmaceutical Working Group submitted comments to the State Administration for Market Regulation on the Measures for the Administration of Advertisement Review of Drugs, Medical Devices, Health Food and Food for Special Medical Purposes (Draft).
Read moreSeminar on Artificial Intelligence Medical Device Administration
The workshop was organized by the Center of Medical Device Evaluation to address regulatory requirements for AI medical devices. Objective: Enhance regulatory requirements for artificial intelligence medical devices in alignment with the Ministry of Science and Technology's research project "New Generation of Artificial Intelligence (2030)."
Symposium on Technical Review of Medical Devices with the Center for Medical Device Evaluation (CMDE)
Symposium on Technical Review of Medical Devices with the Center for Medical Device Evaluation (CMDE)
Read moreMeeting with the Development and Research Centre (DRC) of the State Council on Healthcare Industry
Meeting with the Development and Research Centre of the State Council on Healthcare Industry
Read moreLife and Health Industry Cross-Border Cooperation Conference
Life and Health Industry Cross-Border Cooperation Conference
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