MD-42 sale registration
Dealers, distributors and sellers of medical devices need MD-42 registration from the State Licensing Authority.
- Dealers, distributors and online sellers
- Importers and Indian manufacturers
- Medical devices and IVDs only, under the Medical Devices Rules, 2017
CDSCO medical device guide: all topics
- CDSCO medical device licences (overview)
- MD-42 sale and distribution registration
- Import licence (MD-14 / MD-15)
- Manufacturing licence (MD-5 / MD-9)
- Device risk classification (Class A to D)
- CDSCO medical device FAQ
What is MD-42?
Form MD-42 is the registration certificate for the sale, stocking, exhibition or distribution of medical devices. It was introduced by G.S.R. 754(E) of 30 September 2022, which added a chapter on the sale of medical devices to the Medical Devices Rules, 2017. You apply in Form MD-41 to the State Licensing Authority; in Karnataka this is the Drugs Control Department.
Who needs it
- Medical equipment dealers and distributors
- Surgical and orthopaedic suppliers
- Wholesalers of consumables, implants and IVD kits
- Showrooms that exhibit devices for sale
If you already hold a drug sale licence (Form 20 / 21), you do not need a separate MD-42. Hospitals that only use devices do not need it.
Documents and requirements
- Application in Form MD-41 on the online portal, with the Rs 3,000 fee
- Constitution of the firm: proprietorship declaration, partnership deed or company documents
- Premises proof: ownership document or rent agreement, with the address and layout of the sale and storage area
- Details and qualification proof of the competent technical staff (registered pharmacist, graduate, or 12th pass with one year of experience in selling medical devices)
- Undertaking to follow good distribution practices and proper storage conditions for the devices
- ID proof of the proprietor, partners or directors
The authority may ask for more depending on your premises and products. We check the current list before filing.
Process
- Register on the online medical device portal.
- File Form MD-41 with documents and the fee.
- Reply to queries or inspection by the State Licensing Authority.
- Receive MD-42 and display it at the premises.
- Keep records of purchases and sales and pay the retention fee on time.
Get a free CDSCO licence check
Tell us what you do (sell, import or manufacture), the devices and their class if known, and your city. We will tell you which licence you need, the forms, fees and documents.
Frequently asked questions
Who needs MD-42 registration?
What is the MD-42 fee?
How long is MD-42 valid?
What staff is needed for MD-42?
Does a pharmacy with a drug licence need MD-42?
Is MD-42 needed for online sale of medical devices?
Need a medical device licence?
Talk to the Medasus regulatory team in Bengaluru. We prepare applications, documents and quality systems for MD-42, import and manufacturing licences.
Last reviewed on 2 November 2026 against: CDSCO: Medical Devices Rules, 2017 and notifications; CDSCO online medical device portal: fee schedule (Second Schedule); Drugs Control Department, Karnataka. Medasus Healthcare Pvt Ltd is a private consultancy that helps establishments prepare and file applications. Licences and approvals are granted only by the respective government departments; Medasus cannot guarantee approval or timelines. Rules and fees change, so always check the official source before applying.
