In India, all imported drugs and certain regulated medical devices need to be registered with the Central Drugs Standard Control Organization (CDSCO). For foreign medical companies exporting their products to India, a local Authorized Agent must be appointed.
What are the requirements for an Authorized Agent in India?
- Must be a resident of India or have an official business address in India.
- The Agent must have a drug wholesale license and prior industry experience.
- In India, the local Agent has legal liability for your medical products and must further take care of liaising with the CDSCO, including post-market surveillance.
Who can act as my local agent in India?
- A local agent can be your own subsidiary there, your distributor, or an independent third party. While an Indian distributor could act as your local Agent, if you decide to change distributors in the future and your distributor is not willing to make a friendly transfer, you will normally have to go through the product registration process again.
What are the advantages to using an independent third party as your Authorized Agent in India?
- Using an independent third party as your Indian Authorized Agent would ensure that you have the registration in your name and thus more control of your marketing strategy. It will be also be easier to switch distributors. For foreign companies that do not want to establish a subsidiary in India, an independent third party acting as your local agent is the best way to get your medical products onto the growing Indian market.
Pacific Bridge Medical has decades of experience with pharmaceutical and medical device regulations in India and can represent your company as your in-country representative or local agent in India.
Contact us today to speak with one of our regulatory experts about our in-country representation services and your company’s needs in India.
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