License Holder
License holder is like your virtual office in India.You can appoint multiple distributors and market your product in India through single channel . Product registration will be valid for 5 years.License holder can participate in all the government tender on behalf of principal company
In order to legally sell& market your product in India you need to be compliant to Indian regulations & govt defined systems. We at Biostate will be responsible for pre-certification & post market surveillance inquiries. We can serve as an Authorized Agent/Registration Holder and be your in-country representative for end to-end registration processes including liaising with the regulatory authorities. We will be responsible for pre-certification and post-market surveillance inquiries. Biostate will represent your organisation as your official Indian Authorized Representative in accordance with India applicable regulatory systems. We will represent you legally in Indian market without any commercial conflict of activities like product distribution, marketing, sales etc.
BioState will be there to provide end-to-end support for the registration process. Regulated products such as medical devices & IVDs which are proposed to be imported, manufactured, distributed have to be registered with the designated regulatory consultant before they can be sold or promoted in Indian market. The product which needs to be marketed or proposed to be sold in India can be initiated by an Indian based authorized agent. We act as your Authorized agent in India.
Product registration licenses and Marketing Authorizations of the manufacturer are issued in the name of the appointed India Representative as identified by the manufacturer.