Regulatory Info
- Major Revisions to EU Medical Device Regulations: Removal of 5-Year Certificate Validity? PRRC Requirements Relaxed, New “Breakthrough Device” Pathway EstablishedThe European Commission has re…
- The Era of Brazil’s UDI Mandate Arrives! Mandatory Implementation for Class IV Products, Countdown for Class III BeginsJuly 10, 2025, has become a wa…
- Vietnam Officially Announces Accelerated Approval for Class C and D Medical Devices: New Market Access Opportunities for Chinese ManufacturersReOn 11 December 2025, the Vie…
- Malaysia Medical Device Import Permit System: Implementation Postponed from 2026 to July 2027The Medical Device Authority (…