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( Page 27 )
GB9706.1-2020 testing FAQ
If the manufacturer has carried out risk management according to YY/T0316
“Application of Medical Device Risk Management for Medical Devices”
, can its risk management documents directly meet the risk management requirements of GB9706.1-2020?
more…
Heavyweight! Issued by the Ministry of Finance, which is related to the purchase of medical devices!
The Ministry of Finance has repeatedly stated that China adheres to the principles of openness, transparency and fair competition in government procurement, and ensures fair participation of domestic and foreign enterprises in government procurement competition.
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A guiding principle for comments!
Recently, Center for Medical Device Evaluation.NMPA issued a notice on publicly soliciting opinions on the
Guidelines for the Evaluation of Recombinant Humanized Collagen Raw Materials
(Draft for Comments):
more…
First Approval Of ENT Active Implant In China With Hainan Real World Data
NMPA first approved the ENT active implants in June and July, 2022 with a clinical evaluation report (CER) integrated of Hainan real world data used to support the equivalence justification and provide safety and effectiveness outcomes in Chinese population. BradyKnows provides the turnkey regulatory and clinical solutions to such
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Under what circumstances can surgical instruments be exempted from biological tests?
Based on the current level of cognition, if the materials directly or indirectly contacting patients in surgical instrument products only consist of metal materials, which are verified to conform to the relevant national, industrial and international standards for metal materials for surgical implants or materials for surgical instruments, and the
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Blockbuster! Official release: 301 medical devices have been removed from the list
Recently, the Medical Device Standards Management Center of the NMPA released the
Summary of the Third Classification and Definition Results of Medical Device Products in 2022
, and 75 medical devices were directly excluded.
more…
NMPA: The Classification Catalogue of Medical Devices has been greatly adjusted!
On October 31, the NMPA issued the Notice on
Seeking Adjustment Opinions on the Classified Catalogue of Medical Devices
(hereinafter referred to as the “Notice”), asking for adjustment opinions on the 57 categories of medical devices related to the
Classified Catalogue of Medical Devices
.
more…
China NMPA Newsletter – September 2022
Featured Articles
NMPA New Approvals In September 2022
more…
NMPA New Approvals In September 2022
In September 2022, NMPA approved 222 medical devices, including 24 Class III imported products, 33 Class II imported products, and 163 Class III domestic products.
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Last Call For Testing & Modification Registration Of The GB 9706.1-2020 Standard Upgrade!
If your active medical device was approved by the China NMPA before 2021, most likely, you are not compliant with the newly upgraded Chinese national standard GB 9706.1-2020.
more…
Official release: Support for these medical devices from next year (attached list)
The road of localization of foreign-funded machinery enterprises has been continued to be broadened.
more…
Trend analysis of Chinese medical beauty device industry: minimally invasive and non-invasive treatment will promote the popularization of photoelectric medical beauty device
Data show that in 2021, the market size of China’s medical beauty equipment industry is 54.37 billion yuan. It is expected that in 2023, the market size of China’s medical beauty equipment will reach 77.48 billion yuan and is expected to reach 100 billion scale by 2025.
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