India’s Customs Duty Waiver: Short-Term Relief for Pharma and Medical Device Industry Amid West Asia Crisis
India has granted a customs duty waiver on 40 petrochemical inputs until June 30, 2026. The aim is to ease the burden on pharmaceutical and medical device manufacturers facing raw material price hikes due to the West Asia conflict. The waiver covers critical...
Panel Proposes Decentralising Medical Device Approvals to Clear Bottleneck
India’s parliamentary panel has recommended decentralising medical device approvals to State Licensing Authorities. The aim is to reduce delays, improve efficiency, and strengthen competitiveness. The reforms target bottlenecks in CDSCO processes, especially for...
CDSCO Enforces 90-day SUGAM Portal Application Rejection Rule
SUGAM is the official CDSCO license application portal. It is a single-window online system for regulatory submissions. It ensures faster approvals and clear digital tracking of submissions. Central Drugs Standard Control Organization (CDSCO) has announced a new SUGAM...
US FDA Premarket Approval: Your Comprehensive Guide
FDA has three types of regulatory pathways, namely 510(k), De Novo, PMA, for medical device approval. US FDA premarket approval (PMA) is the most rigorous and stringent regulatory pathway. High-risk devices (Class III devices that sustain life or pose significant...