Overview
Medical devices imported into India for sale or distribution need an import licence from the Central Drugs Standard Control Organisation (CDSCO) under the Medical Devices Rules, 2017. The only exception is Class A devices that are non-sterile and non-measuring, which are registered online instead. The application is made in Form MD-14 and the licence is granted in Form MD-15. Unlike manufacturing licences, which are split between state and central authorities, every import licence is granted by CDSCO, whatever the device’s risk class.
Applications are filed on CDSCO’s medical devices portal at cdscomdonline.gov.in. For the wider picture on device classes and manufacturing licences, see CDSCO medical device registration.
Who needs it
- Foreign manufacturers selling devices in India, through an authorised agent.
- Indian importers and distributors appointed as the authorised agent.
- Indian manufacturers importing finished devices to sell alongside their own.
The authorised agent applies on the manufacturer’s behalf, under a power of attorney, and must hold a manufacturing licence, a wholesale licence or a registration certificate in Form MD-42. The agent is CDSCO’s point of contact for the device, including complaints, adverse events and recalls.
Documents required
- Power of attorney from the foreign manufacturer to the Indian authorised agent
- The agent’s manufacturing licence, wholesale licence or Form MD-42 registration
- Free Sale Certificate from the regulator of the country of origin, and the overseas site’s registration
- Device Master File for each device or family
- Plant Master File for the manufacturing site
- Quality management system certificate, typically ISO 13485, for the site
- Approvals from other regulators, such as CE, US FDA, Health Canada, TGA or PMDA, where available
- Labels and instructions for use meeting India’s labelling rules, including the importer’s details
- Fee paid on the portal for the site and for each device
Process
- Classify each device and decide how to group devices into the application.
- Appoint the authorised agent and execute the power of attorney.
- Collect the manufacturer’s documents and build the Device and Plant Master Files to the Indian format.
- File Form MD-14 on the CDSCO portal and pay the fee.
- CDSCO review. CDSCO examines the dossier and may ask for more information or inspect the overseas site (the rules set a USD 6,000 inspection fee). The rules give CDSCO nine months from application to decide.
- Reply to queries until the application is complete.
- Import licence granted in Form MD-15. Devices can then be cleared through customs and sold.
Free Sale Certificate and clinical data
| Device history | What CDSCO needs |
|---|---|
| Free Sale Certificate from Australia, Canada, Japan, an EU country, the UK or the USA | Licence granted without clinical investigation in India |
| Other countries, Class C or D | Safety and effectiveness shown through clinical investigation in India |
| Other countries, Class A or B | Published safety and performance data, or clinical investigation in the country of origin, plus a Free Sale Certificate |
This is set out in rule 36 of MDR 2017. Checking which row a device falls in, before the manufacturer’s documents are collected, avoids the longest delays.
Fees
| Class | Fee per overseas site | Fee per device |
|---|---|---|
| A (other than non-sterile, non-measuring) | USD 1,000 | USD 50 |
| B | USD 2,000 | USD 1,000 |
| C or D | USD 3,000 | USD 1,500 |
| IVD, Class A or B | USD 1,000 | USD 10 |
| IVD, Class C or D | USD 3,000 | USD 500 |
Fees are from the Second Schedule of MDR 2017. The import test licence (MD-16/MD-17) costs USD 100 per device and is valid for three years.
Validity & retention
An MD-15 import licence stays valid as long as the licence retention fee is paid every five years, unless it is suspended or cancelled. The retention fee equals the licence fee; it can be paid up to 90 days late with a 2% monthly late fee, after which the licence is deemed cancelled. Adding a device, changing the site or making a major change to a device usually needs an application to amend the licence.
Note: Fees and time limits are as set in MDR 2017 at the time of writing. We’ll confirm the current figures before filing.
How Aaditech helps
- Free first consultation: device class, grouping and the documents your manufacturer must supply.
- Gap review of the manufacturer’s technical file against Indian requirements.
- Device and Plant Master Files written in CDSCO’s format.
- Authorised agent support: what the agent’s licence and power of attorney need to cover.
- MD-14 filing on the portal and replies to CDSCO queries through to MD-15 grant.
- Test licence (MD-16/MD-17) for samples, and related approvals such as WPC ETA, BIS QCOs and EPR.
Aaditech is an independent private consultancy, promoted in 2010 by former Directors of the Bureau of Indian Standards. We are not part of CDSCO or any government body. Contact us for a free consultation.
