To be placed on the Indian market, all Medical Devices must be registered with the Indian Regulatory Authority Central Drugs Standard Control Organization (CDSCO).
For Class A and B Medical Devices, documentation must be sent to the State Licensing Authority, which issues the Form MD-5 certification. For class C and D devices, documentation must be sent to the Central Licensing Authority, which will issue the Form MD-7 (for class C devices) and Form MD-8 (for class D devices) certification.
In addition to product certifications, as of October 1, 2023, all devices must present an MD-14 and MD-15 import licence. The MD-14 application process requires the submission of a Device Master File for each medical device and a Plant Master File for each production site. Once the Device Master File and Plant Master File are approved, CDSCO issues the import licence to market the Medical Devices concerned in India.
The foreign manufacturer must appoint a local authorised representative, an Indian Authorized Representative/Agent, responsible for importing the products and in charge of post-market surveillance activities in the territory.
Timeframes and Costs
As for the Device Master File, the cost varies depending on the risk class of the product. For a Class A device, the cost is $50, for a Class B device the cost is $1,000 and for a Class C or D device the cost is $1,500.
Even in the case of the Plant Master File, the cost varies depending on the risk class. Specifically, the cost is $1,000 for a Class A device, $2,000 for a Class B device and $3,000 for a Class C or D device.
Registration times also vary depending on the device class.
Import licences are valid for five years.
Documentation Language and Labelling
The product registration file can be drafted in English.
The labelling (labels and instructions for use) for Medical Devices for professional use can be made available in English while that for devices for domestic use in Indian. In all cases, in addition to the identification details of the foreign manufacturer, it must also include those of the Indian Authorised Representative.
The CDSCO does not require approval of a device from the foreign manufacturer’s home country but does require approval from a reference country including the United States, Canada, Europe, the UK, Switzerland, Australia and Japan.
Regulatory Authority: Central Drugs Standard Control Organisation (CDSCO). Two authorities have been set up to issue certificates: State Licencing Authority (Class A and B devices) and Central Licencing Authority (Class C and D devices)
Classification of Medical Devices: class A (low risk), class B (low-moderate risk), class C (moderate-high risk), class D (high risk)
Quality Management System: ISO 13485:2016