MDA Regulatory Update: Comprehensive Guidance Clarifies Definitions of Medical Device Accessories, Components, and Spare Parts.
Malaysia , 04-December-2025 — The Malaysian Medical Device Authority (MDA) is set to roll out a critical update to its regulatory framework, one that could significantly streamline compliance for local and international manufacturers. The new draft of Guidance Document MDA/GD/0006, which defines what qualifies as a “Medical Device,” offers much-needed clarity on how to treat […]
CDSCO’s New Risk Classification Module for Non-IVD Devices is Now Live
CDSCO LAUNCHES NEW ONLINE MODULE TO FAST-TRACK MEDICAL DEVICE RISK CLASSIFICATION NEW DELHI, DEC 2025 – In a significant move to streamline regulatory processes, the Central Drugs Standard Control Organization (CDSCO) in India has introduced a new, mandatory online module for the risk classification of medical devices. The Circular, issued on December 4, 2025, announced […]