Regulatory Info Jan 29, 2026 Aesthetic Medical Products Are Regulated by ANMAT in Argentina Are aesthetic medical products regulated by ANMAT in Argentina? Read More
Regulatory Info Jan 29, 2026 Malaysia’s Aesthetic Medical Device Regulations Officially Take Effect The Directive has been formally gazetted, with mandatory enforcement commencing on 1 June 2026. 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 the safety, quality, and performance of medical devices used in public healthcare institutions, the Hong Kong Department of He… 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 has recently published its long-anticipated proposal to revise the Medical Device Regulation (MDR) and the In Vitro Diagnostic… 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 a watershed moment for Brazil's medical device market regulation—the Unique Device Identification (UDI) compliance requireme… 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, the Vietnamese Ministry of Health (MOH) officially promulgated a key regulatory decision introducing 10 standardized and fully … Read More
Regulatory Info Jan 13, 2026 Malaysia Medical Device Import Permit System: Implementation Postponed from 2026 to July 2027 The Medical Device Authority (MDA) has announced that the medical device import permit system, originally scheduled to t… Read More
Regulatory Info Jan 12, 2026 A Brief Guide to Medical Device Registration for Importation in Zambia The Republic of Zambia is a landlocked country in south-central Africa. Market access for medical devices in Zambia is subject to regulatory approval … Read More