Our CDSCO medical device services cover classification, Indian Agent support, dossier preparation, online filing and licence maintenance.
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Every medical device and in-vitro diagnostic (IVD) sold in India must be licensed by the Central Drugs Standard Control Organisation (CDSCO) under the Medical Devices Rules, 2017 (MDR 2017). Foreign manufacturers need an import licence in Form MD-15, held through an Authorised Indian Agent; Indian manufacturers need a manufacturing licence from the State or Central Licensing Authority, depending on device class. PCN Global India Corporation is a CDSCO medical device registration consultant that handles classification, dossier preparation, online filing and query management through to grant.
| Class | Risk | Manufacturing Licence Authority | Examples |
|---|---|---|---|
| Class A | Low | State Licensing Authority | Surgical dressings, absorbent cotton, tongue depressors |
| Class B | Low–moderate | State Licensing Authority | BP monitors, hypodermic needles, suction equipment |
| Class C | Moderate–high | Central (CDSCO) | Ventilators, dialysis machines, bone-fixation plates |
| Class D | High | Central (CDSCO) | Heart valves, pacemakers, coronary stents |
| Activity | Application → Licence | Authority |
|---|---|---|
| Import (all classes) | MD-14 → MD-15 | CDSCO |
| Manufacture, Class A & B | MD-3 → MD-5 | State Licensing Authority |
| Manufacture, Class C & D | MD-7 → MD-9 | CDSCO |
| Loan licence | MD-4 → MD-6 (A/B); MD-8 → MD-10 (C/D) | SLA / CDSCO |
| Test licence (samples for testing or evaluation) | MD-12 → MD-13 | CDSCO |
Confirm risk class, grouping of devices and the right regulatory pathway.
Appoint an Indian Agent with a valid licence to file and hold responsibility in India.
Device Master File (DMF), Plant Master File (PMF), ISO 13485 certificate, Free Sale Certificate, risk analysis and labels.
Application filed on CDSCO’s online medical device portal with government fees.
We draft responses to every CDSCO query well within the permitted time.
Import licence issued — valid for customs clearance and sale across India.
| Class | Per Site | Per Distinct Device |
|---|---|---|
| Class A | USD 1,000 | USD 50 |
| Class B | USD 2,000 | USD 1,000 |
| Class C & D | USD 3,000 | USD 1,500 |
IVD per-device fees are lower. Government fees are separate from professional charges and can change — we confirm current rates at the time of filing.
| Licence | Typical Timeline |
|---|---|
| Import licence MD-15 | 6 – 9 months (longer for complex Class C/D devices without a predicate) |
| Manufacturing MD-5 (Class A/B) | 3 – 6 months, including Notified Body audit |
| Manufacturing MD-9 (Class C/D) | 6 – 9 months, including CDSCO inspection |
| Test licence MD-13 | 3 – 4 weeks |
MD-5, MD-9 and MD-15 licences remain valid unless suspended or cancelled, provided the retention fee is paid every five years.
Share your device list and intended use — we will confirm the class, licence route, fees and a realistic timeline.
CDSCO, under the Drugs Controller General of India, issues all import licences and manufacturing licences for Class C and D devices. State Licensing Authorities issue manufacturing licences for Class A and B devices.
Form MD-15 is the medical device import licence granted by CDSCO after an application in Form MD-14. It is required to import devices of any class into India.
No. A foreign manufacturer must appoint an Authorised Indian Agent holding a valid wholesale, manufacturing or import licence, who files the application online and is responsible for the product in India.
An MD-15 import licence typically takes 6 to 9 months, and longer for complex Class C or D devices. Answering CDSCO queries quickly is the main factor you can control.
Yes, an ISO 13485 certificate for the manufacturing site is a standard part of the import licence dossier, along with the Device Master File, Plant Master File and Free Sale Certificate.
Import and manufacturing licences are perpetual — valid unless suspended or cancelled — provided the retention fee is paid every five years.
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