This week in medical device regulatory news: Brazil expedites registration of IVDs for mosquito-born diseases; new US FDA guidance on endosseous dental implants and abutments.
ANVISA has announced a new initiative to expedite the registration of diagnostic tests for diseases caused by mosquitoes, including dengue, chikungunya, and oropouche fever. This prioritization aims to enhance early diagnosis and treatment options for arboviral infections, which significantly impact public health in Brazil, especially during the rainy season when mosquito breeding increases. Effective until December 31, 2024, this measure applies to both new and pending requests for medical devices and Good Manufacturing Practices Certifications. Together, we can combat these diseases—let's all do our part by preventing stagnant water!
Learn more about ANVISA Brazil Medical Device Registration.
The FDA has issued new guidance, effective October 15, 2024, outlining performance criteria for endosseous dental implants and abutments under the Safety and Performance Based Pathway. This guidance allows 510(k) submitters to use performance criteria, rather than direct comparisons to predicate devices, to demonstrate substantial equivalence. The document provides recommendations for industry and FDA staff, streamlining the regulatory process while ensuring public health safety. The guidance is immediately applicable but remains open for public comment.
Learn more about FDA US Medical Device Registration.
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On October 23, the European Parliament adopted a resolution revising specific elements of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Devices Regulation (IVDR). This resolution intends to address ongoing challenges in implementing the regulations by 2025 and to improve patient access to important medical products.
Multilingual documentation presents ongoing compliance and logistical hurdles for MedTech manufacturers. Transla.Ai is an industry-specific translation tool that can accelerate and streamline the translation process.