Government plans to replace the Drugs & Cosmetics Act, 1940. This highlights a major regulatory shift. The Draft Drugs, Medical Devices & Cosmetics Bill, 2026 aims to replace the 1940 Act. It will consolidate drug, device, and cosmetic regulation under one...
Testing laboratories in India must obtain official approval to conduct medical device testing for regulatory purposes. This registration ensures that only accredited and compliant labs are authorized to generate test reports accepted by CDSCO. It is a critical step in...
Are you looking for a CDSCO consultant in Panchkula? Well, you have landed in the right place. We at Pharmadocx Consultants will make the process of securing the CDSCO license a breeze for you. Our service covers CDSCO licensing for pharmaceuticals, medical devices,...
Starting a medical device startup involves blending innovation with regulatory discipline. Entrepreneurs must begin by identifying unmet clinical needs and designing solutions that are both technically feasible and commercially viable. Moreover, they must...
Class Ir surgical instruments require CE marking under the EU MDR. Notably, notified body involvement is limited to reprocessing aspects (cleaning, disinfection, sterilization, maintenance, functional testing). Unlike general Class I devices, manufacturers cannot...
Class III medical devices are the FDA’s highest-risk category and require rigorous Premarket Approval (PMA) before marketing. These devices sustain or support life, prevent serious health impairment, or pose significant risk if they fail. Unlike Class I and II...