Regulatory Info Mar 6, 2026 Malaysia CAB: The “Gatekeeper” of Medical Device Compliance Are you planning to expan… Read More
Regulatory Info Mar 6, 2026 EU Confirms Mandatory Use of First Four EUDAMED Modules from 28 May 2026 ndatory Use of First Four… Read More
Regulatory Info Feb 26, 2026 FDA Issues Landmark Final Guidance: Computer Software Assurance for Production and Quality Management System Software (FDA-2022-D-0795) On February 3, 2026, the … Read More
Regulatory Info Jan 29, 2026 Canada Updates Medical Device Licence Application Fees (2026 Edition) Recently, Health Can… Read More
Regulatory Info Jan 29, 2026 Vietnam Introduces New Regulations: Medical Devices to Be Classified into Six Groups Based on Technical Standards and Quality, Effective in 2027 Recently, the Vietna… Read More
Regulatory Info Jan 29, 2026 Aesthetic Medical Products Are Regulated by ANMAT in Argentina Are aesthetic medica… Read More
Regulatory Info Jan 29, 2026 Malaysia’s Aesthetic Medical Device Regulations Officially Take Effect The Directive has be… Read More
Regulatory Info Jan 13, 2026 [Important Notice from Hong Kong Department of Health] Phase C New Regulations Effective March 2026 – Complete Medical Device Listing Applications Promptly To continuously enhance t… Read More
Regulatory Info Jan 13, 2026 Major Revisions to EU Medical Device Regulations: Removal of 5-Year Certificate Validity? PRRC Requirements Relaxed, New “Breakthrough Device” Pathway Established The European Commission h… Read More
Regulatory Info Jan 13, 2026 The Era of Brazil’s UDI Mandate Arrives! Mandatory Implementation for Class IV Products, Countdown for Class III Begins July 10, 2025, has become… Read More
Regulatory Info Jan 13, 2026 Vietnam Officially Announces Accelerated Approval for Class C and D Medical Devices: New Market Access Opportunities for Chinese Manufacturers ReOn 11 December 2025, th… Read More
Regulatory Info Jan 13, 2026 Malaysia Medical Device Import Permit System: Implementation Postponed from 2026 to July 2027 The Medical Device A… Read More
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