Manufacturing licence
Indian manufacturers of medical devices need a manufacturing licence that depends on the device class.
- 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
Which licence?
| Class A or B | Class C or D | |
|---|---|---|
| Application | Form MD-3 | Form MD-7 |
| Licence | Form MD-5 | Form MD-9 |
| Issued by | State Licensing Authority | CDSCO (Central Licensing Authority) |
| Audit / inspection | Notified body audit | CDSCO inspection, with experts |
Official fees
| Manufacturing licence fee (Second Schedule) | Per site | Per distinct device |
|---|---|---|
| Class A or B (Form MD-3, rule 20) | Rs 5,000 | Rs 500 |
| Class C or D (Form MD-7, rule 21) | Rs 50,000 | Rs 1,000 |
| Retention fee (rule 29), Class A or B | Rs 5,000 | Rs 500 |
| Retention fee (rule 29), Class C or D | Rs 50,000 | Rs 1,000 |
| Test licence (Form MD-13, rule 31) | Rs 500 per distinct device | |
What manufacturers need
- Premises and plant layout suited to the device, with clean areas where needed
- Quality management system as per the Fifth Schedule (aligned with ISO 13485)
- Device master file and plant master file
- Competent technical staff for manufacturing and testing
- Test reports and essential principles conformity
- Labelling as per the Rules
Process
- Classify each device.
- Build the QMS and files.
- Apply online in MD-3 or MD-7 with the fee.
- Audit or inspection of the site.
- Close observations and receive MD-5 or MD-9.
- Pay retention fees and report changes.
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 issues a manufacturing licence for Class A and B devices?
Who issues a manufacturing licence for Class C and D devices?
What is the manufacturing licence fee?
Is ISO 13485 required?
Do Class A non-sterile, non-measuring devices need a licence?
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.
