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2024 China NMPA Bluebook is here:
The NMPA published a notice “Further Clarify the Registration and Use of Medical Device Master Files” on January 18, 2023. To protect medical device raw materials’ intellectual rights, it asks
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in November 2022. These updates are presented by China Med Device, your partner in
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros issued in April 2022. These updates are presented by China Med Device, LLC, your partner
Here’s the latest China regulatory and clinical affairs China NMPA News March 2022 for medical device and IVDs pros. These updates are presented by China Med Device, LLC, your partner
Three fast-track channels have been established by the NMPA to encourage innovation and deal with unmet medical needs: Innovation Approval, Priority Review, and Emergency Approval. For Priority Review, applicants for
The NMPA published the “Catalog of Medical Devices Prohibiting of Entrusted Production” on November 17, 2021, providing the scope of 22 devices which are not allowed for contract manufacturing. NMPA has introduced the MAH
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in October 2021. These updates are presented by China Med Device, LLC, your partner in
Unlike the “Medical Device Classification Rules”, the NMPA did not separately regulate the classification of IVD reagents before. Instead, the guidelines were written into the “Notice on Issuing the Registration
The NMPA issued the “Notice regarding implementation of Medical Device Registration and Filing Management Measures and In Vitro Diagnostic Reagents Registration and Filing Management Measures” which have been effective since
The last time the “Medical Device Registration Administrative Measures” were completely overhauled was in 2014. The newer regulations with significant changes have been introduced focusing on expediting innovation, complete product
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros. These updates are presented by China Med Device LLC, your partner in Chinese market access.
The NMPA issued the second draft “Regulations on Self-test of Medical Device Registration (Draft)” on July 23, 2021, proposing further guidance to manufacturers on how to self-test and to submit
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