In India, the regulation of In Vitro Diagnostic (IVD) medical devices is governed by the Central Drugs Standard Control Organization (CDSCO). IVD Rules provide a regulatory framework for the manufacture, import, sale, and distribution of IVD devices, ensuring that they meet safety and performance standards before being made available to the public.
Local manufacturers of IVD devices must obtain a manufacturing license from the State Licensing Authority. They must also comply with Good Manufacturing Practices (GMP) and conduct necessary testing to ensure the accuracy and reliability of the devices. The manufacturers are required to submit detailed technical documentation, including clinical trial data where applicable.
Importers of IVD devices must obtain an import license from CDSCO and submit various documents such as the ‘Certificate of Free Sale’ from the country of origin and a ‘Product Registration Certificate’. The products must also meet Indian safety and performance standards before they can be sold in the market.
ACPL offers expert assistance to companies seeking to obtain IVD-related licenses. We help with product registration, obtaining manufacturing and import licenses, GMP compliance etc. Our team ensures that IVD devices meet regulatory requirements, helping companies navigate the approval process smoothly and efficiently, so they can focus on their core business.
Let ACPL manage your IVD licensing needs while you focus on growing your business !!
