EMERGO SUMMARY OF KEY POINTS:

• India’s new Medical Device Rules include expanded responsibilities for India Authorized Agent in-country representatives.
• India Authorized Agents will have added importation responsibilities, and CDSCO will allow multiple Agents for imported devices.
• Agent role changes will go into effect assuming that Indian regulators are able to meet their own early 2018 implementation timeframe.

The role of in-country representatives for medical device manufacturers registered in India will change substantially under the country’s new Medical Device Rules published earlier in 2017.

According an analysis of the new Rules by Emergo consultants, responsibilities of India Authorized Agents that interact with regulators at the Central Drugs Standard Control Organization (CDSCO) on behalf of foreign manufacturers will apparently expand once (or if) the Medical Device Rules go into effect as planned in January 2018. Two major aspects of the Agent role set to change are discussed below.

Import Licenses folded into Agent role

Under the current Indian regulatory system, Agent and Importer roles are separate; importers must obtain Form 10 Import Licenses, and there is no limit to the number of importers who may apply for a license per single device registration.

The new Rules, however, do not treat Import Licensing as a separate activity. Agents will not only represent foreign manufacturers but also serve as their importers to India (via power of attorney). This means Agents would have to officially buy and assume responsibility for devices coming into the country.

Multiple registrations per device allowed

As of now, the CDSCO allows only one registration per medical device, as well as representation by a single Agent.

The new Rules will not prohibit multiple registrations for one device, however, which will likely lead to all distributors and importers obtaining their own individual regulatory approvals from CDSCO.

Implementation of these and other changes assumes that the Indian government meets the aggressive January 2018 deadline it set for the Medical Device Rules to take effect.

Further resources and information on Indian medical device registration:

• India CDSCO registration consulting for medical device companies
• India Authorized Agent in-country representation
• Indian medical device approval video overview
• Indian regulatory process chart