CDSCO RELEASES UPDATED GUIDANCE ON IVD/ MEDICAL DEVICE GUIDANCE IMPORTS

CDSCO RELEASES UPDATED GUIDANCE ON IVD/ MEDICAL DEVICE GUIDANCE IMPORTS

Flowchart showing CDSCO IVD import process via MD Online and NSWS portals.

NEW DELHI, India — On January 30, 2026, the Central Drugs Standard Control Organization (CDSCO) reached a significant milestone in India’s medical device regulatory landscape by releasing a comprehensive draft guidance document for the import of In-vitro Diagnostic (IVD) medical devices. Aimed at bringing clarity to the industry, the document serves as a “how-to” manual […]

Thai New FDA Labeling Standard (B.E. 2568) Published in Gazette

Thailand FDA 2026 medical device labeling rules for home use and professional use devices

Thailand, 06, FEB 2026 — The Thai Ministry of Public Health has officially published the new Announcement regarding Criteria, Methods, and Conditions for Displaying Labels and Documentation for Medical Devices B.E. 2568 (2025) in the Gazette. This long-awaited update modernizes the regulatory landscape for medical device FDA labeling in Thailand, introducing distinct requirements for “Home […]

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