Authorized Indian Representative for a foreign manufacturer
A foreign manufacturer without an Indian legal entity gained seamless regulatory representation in India.
Industry
Medical devices / IVD
Location
India
Services
License Holder Services
Category
License Holder Services
License Holder ServicesA foreign manufacturer without an Indian legal entity required an Authorized Indian Representative, faced regulatory communication challenges, and needed ongoing compliance management.
Foreign Manufacturer
Client Type
Medical devices / IVD
Product Category
India
Target Market
Challenges Faced
- Requirement for an Authorized Indian Representative.
- Regulatory communication challenges.
- Ongoing compliance-management requirements.
Our Approach
- Provided License Holder and Authorized Agent services under our local registration.
- Managed regulatory correspondence with the authorities on the manufacturer’s behalf.
- Coordinated import license activities throughout the engagement.
- Supported post-market surveillance obligations on an ongoing basis.
A clear path, milestone by milestone
License Holder / Authorized Agent
Regulatory correspondence
Import license coordination
Post-market surveillance
What it meant for the client
Seamless regulatory representation in India.
Continuous compliance support.
Successful product distribution in the Indian market.
Key Results
Authorized
Indian representative
Managed
Regulatory correspondence
Coordinated
Import licensing
Ongoing
Compliance support
Every engagement is led by senior regulatory experts — with transparent milestones, complete documentation, and fixed-scope clarity from day one.
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