In this week's regulatory update, we bring you news from Brazil and China, including new guidelines for medical device clinical trial inspections from China's NMPA and the availability of medical device price monitoring data on ANVISA's Business Intelligence dashboards.
ANVISA has reinstated the publication of medical device price monitoring data on its Business Intelligence (BI) dashboards. The temporary suspension was due to internal regulatory changes and process improvements to enhance accuracy and efficiency. With the update, users can once again track price trends, promoting transparency and supporting regulatory analysis. This initiative reaffirms ANVISA’s commitment to providing accessible and reliable market information.
Learn more about ANVISA Brazil Medical Device Registration.
The National Medical Products Administration (NMPA) has announced the release of updated Key Points and Judgment Principles for the Inspection of Medical Device Clinical Trial Projects. This revision aims to standardize inspection procedures, unify judgment criteria, and enhance the quality of clinical trial inspections. The guidelines outline regulatory compliance requirements, consequences for authenticity issues, and handling procedures for non-compliance. The new regulations will take effect on May 1, 2025, replacing previous directives.
Learn more about China Medical Device Registration & Approval.
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