Indian Authorized Agent for Medical Devices

Pharmacist writing on clipboard in pharmacy

Indian Authorized Agent for Medical Devices

Regulatory Representation for Foreign Medical Device Manufacturers

At Isha’s GMP Consultancy, we act as a trusted Indian Authorized Agent (IAA) for foreign medical device manufacturers seeking market entry in India. Our expertise ensures seamless registration, compliance, and distribution while allowing you to remain independent and maintain full control over your business strategy.

Why You Need an Indian Authorized Agent (IAA)?
 

Foreign medical device manufacturers must appoint an Indian Authorized Agent (IAA) to represent them before the Central Drugs Standard Control Organization (CDSCO) for:

  • Medical Device Registration & Licensing
  • Regulatory Compliance & Documentation
  • Import & Distribution Support
  • Post-Market Surveillance & Communication with Authorities

Our Unique Solution: Hassle-Free Regulatory Partnership

We help you with:

  • Application Assessment & Submission – Ensuring a smooth registration process with CDSCO.
  • Regulatory Representation – Acting as your administrative & commercial contact in India.
  • Product & Business Registration – Assisting with Form 41 & Form 10 approvals.
  • Record-Keeping & License Management – Hosting all regulatory records & compliance documentation.
  • Import & Distribution Support – Helping you bring your medical devices to the Indian market.

Key Advantages of Partnering with Isha’s GMP

  • Maintain Full Business Control – You remain independent & autonomous.
  • Freedom to Choose Distributors – Select your local partners without restrictions.
  • Customized Market Strategy – Determine your pricing & sales approach.
  • Regulatory & Administrative Support – We handle all compliance aspects so you can focus on business growth.
  • Expert Team – Highly experienced regulatory professionals ensuring smooth approvals.
Get in touch today to appoint Isha’s GMP as your trusted Indian Authorized Agent for CDSCO compliance & market entry!

Medical Device