ARTICLE SUMMARY:
In this week’s Pathways Picks: Brazil issues regulatory reliance policy to streamline premarket reviews; China details contract manufacturer controls; EU issues update on single-use device reprocessing; US policymakers discuss telehealth reimbursement and broader physician Medicare issues. And from the FDA: Commissioner Califf testifies on Capitol Hill; CDRH seeks panelist nominations; and Philips consent decree finalized.
[Editors note: We will not be publishing Pathways Picks next week on April 17. Keep tabs on medtech regulation and policy updates and analysis at Market Pathways’ website. ]
Global Picks
China, EU, and UK updates:
Brazil publishes reliance regulation. The country’s ANVISA regulatory authority published a regulation (link in Portuguese) April 8 outlining procedures for regulatory reliance on four foreign governments as a means to streamline device authorization decisions in Brazil. The regulation, which takes effect June 3, designates US FDA, the Australia Therapeutic Goods Administration, Health Canada, and Japan’s Ministry of Health, Labor, and Welfare as recognized authorities. Devices authorized by at least one of these agencies can benefit from a quicker ANVISA review that relies on documentation from the foreign authority as a sole or complementary reference rather than requiring a manufacturer submit a full technical dossier. The regulations specifies that devices authorized via abbreviated routes in the referenced countries don’t qualify and that ANVISA has ultimate decision-making authority and can always request a full dossier.
