Overview
In India, medical devices are regulated by the Central Drugs Standard Control Organisation (CDSCO) under the Medical Devices Rules, 2017 (MDR 2017), made under the Drugs and Cosmetics Act, 1940. This is a separate regime from BIS certification. The licence a device needs depends on two things: its risk class (A, B, C or D) and whether it is imported or made in India.
The rules took effect on 1 January 2018 for devices already notified at the time, such as stents, syringes and in-vitro diagnostics. In 2020 every other medical device was brought under the rules, with licensing phased in: from 1 October 2022 for Class A and B, and from 1 October 2023 for Class C and D. Today a device that is imported, manufactured, sold or distributed in India needs the licence or registration that applies to its class.
Applications are made online on CDSCO’s medical devices portal at cdscomdonline.gov.in. CDSCO publishes the rules, classification lists and guidance at cdsco.gov.in.
Risk classes
| Class | Risk | Typical examples | Manufacturing licence from |
|---|---|---|---|
| A | Low | Surgical dressings, tongue depressors, non-sterile examination products | State Licensing Authority |
| B | Low to moderate | Hypodermic needles, suction equipment, thermometers | State Licensing Authority |
| C | Moderate to high | Ventilators, bone fixation implants, infusion pumps | CDSCO (Central Licensing Authority) |
| D | High | Heart valves, implantable defibrillators, cardiac stents | CDSCO (Central Licensing Authority) |
Examples are indicative. The class is set by CDSCO’s published lists or by the classification rules in the First Schedule, so it is checked for your specific device and intended use. See our guide to medical device classification in India.
Which licence you need
| Activity | Application | Licence | Granted by |
|---|---|---|---|
| Class A, non-sterile and non-measuring (manufacture or import) | Online registration | System-generated registration number | CDSCO portal, no fee |
| Manufacture, Class A (other) or B | Form MD-3 | Form MD-5 | State Licensing Authority |
| Manufacture, Class C or D | Form MD-7 | Form MD-9 | CDSCO |
| Import, any class | Form MD-14 | Form MD-15 | CDSCO |
| Manufacture for test, evaluation or clinical investigation | Form MD-12 | Form MD-13 | CDSCO |
| Import for test, evaluation or clinical investigation | Form MD-16 | Form MD-17 | CDSCO |
Traders who only sell medical devices register their premises in Form MD-41 and receive a registration certificate in Form MD-42 from the State Licensing Authority. Importers should also read our page on the medical device import licence (MD-14/MD-15).
Government fees and timelines
| Licence | Fee per site | Fee per device | Time limit in the rules |
|---|---|---|---|
| Manufacture, Class A (other than non-sterile, non-measuring) | Rs 5,000 | Rs 500 | Grant within 45 days; notified body audit within 120 days after grant |
| Manufacture, Class B | Rs 5,000 | Rs 500 | Notified body audit within 90 days of application, then grant |
| Manufacture, Class C or D | Rs 50,000 | Rs 1,000 | Inspection within 60 days; grant within 45 days of the inspection report |
| Import, Class A / B / C or D | USD 1,000 / 2,000 / 3,000 | USD 50 / 1,000 / 1,500 | Decision within 9 months |
| Test licence (manufacture) | None | Rs 500 | Decision within 30 days |
Fees are from the Second Schedule of MDR 2017 and time limits from rules 20 to 36. In-vitro diagnostic devices have lower per-device import fees. Retention fees every five years equal the licence fees.
Documents required
- Device Master File for each device or family, covering description, intended use, design, materials, risk management, verification and validation, and labelling
- Plant Master File describing the manufacturing site and its controls
- Quality management system evidence to the Fifth Schedule of MDR 2017, which is modelled on ISO 13485
- Test reports and, where relevant, biocompatibility, electrical safety and sterilisation validation data
- Labels and instructions for use that meet the labelling rules
- For imports: Free Sale Certificate from the country of origin, power of attorney for the Indian authorised agent, and the agent’s manufacturing licence, wholesale licence or Form MD-42 registration
- Company constitution, site address proof and the fee paid on the portal
Most queries from the licensing authority come from gaps between the Device Master File, the labels and the test data. We check these against each other before filing.
Process
- Classify the device. Confirm the risk class, the intended use statement and how devices can be grouped into one application.
- Choose the route. Manufacturing (state or central) or import, plus any test licence needed for samples.
- Prepare the dossier. Device Master File, Plant Master File, QMS evidence and labels.
- Register and file on the portal. Create the applicant account, upload the dossier and pay the fee.
- Audit or inspection. Class B sites are audited by a notified body before grant, and Class A sites within 120 days after grant. Class C and D sites are inspected by CDSCO’s medical device officers before grant. Import applications are reviewed by CDSCO, which may inspect the overseas site.
- Reply to queries raised by the licensing authority.
- Licence granted on the portal. Keep the retention fee, post-market surveillance and change notifications up to date.
Validity, renewal & post-market duties
Licences under MDR 2017 do not expire on a fixed date. They remain valid as long as the licence retention fee is paid every five years. Late payment attracts a 2% monthly fee, and a licence whose retention fee stays unpaid beyond the grace period is deemed cancelled. Test licences are the exception: they are valid for three years. Licence holders must report adverse events, run post-market surveillance, and inform or seek approval from the authority before major changes to the device, site or labelling.
Note: Fees and time limits above are as set in MDR 2017 at the time of writing. CDSCO has published draft amendments to shorten some timelines; we’ll confirm the current position for your application before filing.
How Aaditech helps
Aaditech was promoted in 2010 by former Directors of the Bureau of Indian Standards and has worked on Indian product regulation since. For medical devices we handle the whole file:
- Free first consultation to confirm the class, the licensing authority and every approval your device needs.
- Dossier preparation: Device Master File, Plant Master File and label review.
- QMS readiness to the Fifth Schedule and ISO 13485.
- Portal filing on CDSCO’s medical devices portal, and replies to queries through to grant.
- Foreign manufacturers: guidance on appointing an Indian authorised agent and on import licence documents.
- Related approvals: BIS QCOs for X-ray equipment and medical textiles, AERB approvals for X-ray equipment, WPC ETA for wireless devices, and EPR registration.
Aaditech is an independent private consultancy and is not part of CDSCO or any government body. Contact us for a free consultation on your device.
