Representative Services

Indian Authorized Agent (IAA)

Your Trusted Partner for Medical Device Registration in India

Navigating the regulatory landscape of India's medical device industry can be complex. As per the Medical Device Rules (MDR) GSR 78(E), foreign manufacturers intending to market medical devices in India must appoint an Indian Authorized Agent. We provide comprehensive Indian Agent services to ensure smooth compliance with Indian regulatory requirements.

Why Choose Us as Your Indian Authorized Agent?

Regulatory Expertise

Our team of regulatory professionals is well-versed in Indian MDR, ensuring seamless registration and compliance.

DCGI & CDSCO Liaison

We act as a bridge between foreign manufacturers and India's Central Drugs Standard Control Organization (CDSCO).

End-to-End Compliance Support

From dossier preparation to obtaining regulatory approvals, we handle all requirements efficiently.

Post-Market Compliance

We assist in post-market surveillance, reporting, and regulatory updates.

Confidentiality & Transparency

We prioritize protecting your business information and ensure a transparent process.

Our Services

Indian Authorized Agent Representation

  • As mandated by MDR GSR 78(E), foreign manufacturers must appoint a local representative in India. We serve as your reliable Indian Agent, ensuring full regulatory compliance.

Medical Device Registration & CDSCO Approvals

  • We manage the registration of Class A, B, C, and D medical devices with CDSCO, handling documentation, submission, and follow-ups.

Import License Assistance

  • We assist in obtaining the required Form MD-15 & MD-14 Import Licenses, enabling the legal import of medical devices into India.

Post-Market Surveillance & Compliance

  • We facilitate adverse event reporting, vigilance submissions, and ensure continuous regulatory compliance post-market approval.

Renewals & Modifications

  • We provide support for license renewals, modifications, and amendments in compliance with evolving regulations.

Who Needs an Indian Authorized Agent?

Contract Manufacturers & Suppliers

Foreign Manufacturers without a physical presence in India.

Medical Device & IVD Manufacturers

Medical Device Companies looking to enter the Indian market.

Distributors & Importers

Regulatory Consultants seeking local representation for their clients.

How to Appoint Us as Your Indian Agent?

  • Contact Us – Reach out to our regulatory experts for a consultation.
  • Agreement & Documentation – Sign an official agreement for Indian Agent representation.
  • Regulatory Submission – We handle device registration, import licensing, and compliance.
  • Ongoing Compliance Management – We ensure smooth operations and regulatory adherence.
Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

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