What is an MD 42 License? A Complete Guide for Manufacturers & Importers

The MD 42 License is a regulatory approval issued under India’s Medical Device Rules for manufacturing or importing certain Class C and Class D medical devices. It ensures that these devices meet prescribed safety, quality, and performance standards before being sold in the market. Businesses engaged in producing or importing such medical devices must obtain this license from the Central Licensing Authority. The application process involves submitting technical documentation, quality management system details, and device test reports. Holding an MD 42 License demonstrates compliance with regulatory norms, enabling companies to operate legally and gain trust in the healthcare industry

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