Import License & Registrations

Our Experienced Professionals are familiar with all aspects of Medical Device Regulatory Compliance in India. Our services include obtaining Medical Device Registration & Approval for Foreign Manufacturers in Form 41 and Import Licenses in Form 10.

Sugam Registration:

This is the Government of India e-Governance Initiative. The Central Drugs Standard Control Organization (CDSCO) has created this Portal for the security of Pre-registering the Applicants for the services rendered by them. An Online Licensing Portal of CDSCO has been launched on 14 November, 2015 and has been named “SUGAM”. It is a reliable, fast, and spam-free portal that has been launched by the Ministry of Health & Family Welfare. Our Team of Experienced Professionals will be Happy to Serve you for Sugam Resigration.

Medical Device Registration Certificate in Form 41 (For Foreign Manufacturer)

  • Determine whether your Device fits or not into the list of notified Medical Devices Regulated Under Drugs and Cosmetics Act, 1940; and Rules, 1945.
  • Coordinate the Device Registration and Approval Process with Indian Medical Device Regulators (DCG(I)/CDSCO)
  • Collation of all necessary Documents for the Product Registration Application including Forms 40.
  • Submission of Site Master File, Plant Master File and Device Master File as needed.
  • Coordinating with the DCG(I)/CDSCO to address follow up Questions and Monitor Progress. Ask for quotation...

Import License in Form 10

  • Determine whether your Device fits or not into the list of notified Medical Devices Regulated Under Drugs and Cosmetics Act, 1940; and Rules, 1945.
  • Coordinate with Indian Medical Device Regulators (DCG(I)/CDSCO).
  • Collation of all necessary Documents for Submission of Application.
  • Suggesting Appointing an Indian Agent as your Official Representative.
  • Submission of Site Master File and Device Master File as needed.
  • Coordinate with the DCG(I)/CDSCO to address follow up Questions and Monitor Progress. Ask for quotation...

 

LICENCE AND PERMISSION AS PER MEDICAL DEVICE RULES 2017 EFFECTIVE FORM 01st JANUARY 2018

  • Licence to Manufacture Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training on Form MD-13
  • Licence to Import Medical Device on Form MD-15
  • Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training on Form MD-17 
  • Licence to Import Investigational Medical Device by a Government Hospital or Statutory Medical Institution for the Treatment of Patients on Form MD-19
  • Permission to Import of Small Quantity of Medical Devices for personal use on Form MD-21 Ask for quotation...