The medical device sector in India has witnessed tremendous growth, leading to increased emphasis on regulatory compliance. Under the Medical Device Rules (MDR), 2017, businesses selling or distributing Class A and Class B medical devices must obtain the MD 42 License. This license ensures that entities handling medical devices operate legally while maintaining quality standards. In regions like Delhi NCR and Haryana, where healthcare infrastructure is rapidly expanding, MD 42 License Registration has become a primary requirement for traders, distributors, and stockists.
The MD 42 License grants permission to exhibit, sell, or stock medical devices. With growing demand in hospitals, diagnostics centers, and pharmacies, more businesses are entering this sector. However, due to strict regulatory oversight, no business can operate without securing the necessary license from the State Licensing Authority. The registration process not only legitimizes the business but also improves its market credibility.
Who Needs MD 42 License?
Medical device traders and wholesalers
Retailers dealing in Class A & B devices
Warehouses stocking and supplying medical devices
E-commerce sellers offering medical devices
Distributors and supply chain partners
This license applies to devices such as thermometers, BP monitors, surgical gloves, orthopedic supports, syringes, diagnostic kits, and other low-risk devices.
Steps for MD 42 License Registration
Create an account on the CDSCO SUGAM portal.
Prepare required documents, including qualification proof of the competent technical person.
Upload documents such as site plan, ownership proof, cold storage details, and company information.
Submit the application along with the applicable government fees.
Inspection by Drug Inspector (based on state requirements).
Issuance of License after verification and approval.
The process generally takes 30–45 working days, depending on the responsiveness of the applicant and regulatory authorities.
Benefits of Obtaining an MD 42 License
Legal authorization to deal in medical devices
Improved trust among hospitals, distributors, and clients
Smooth participation in government tenders
Protection from penalties or legal action
Capability to scale operations across Delhi NCR and Haryana
Compliance with MDR 2017 ensures quality and safety, reducing the chances of distribution of defective or non-compliant medical devices.