BEST CONSULTANT FOR MEDICAL DEVICES AND PHARMACEUTICAL REGULATORY, CDSCO, ISO, CE, ISI, USFDA, MDSAP, 510k, TGA AUSTRALIA & QUALITY MANAGEMENT SYSTEM CERTIFICATION

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Import / Export Registration of Medical Devices

Import & Export Licenses for Medical Devices and Drugs

We have Experienced and Enthusiastic Professionals that help your Organization to get registered your Facility and Devices as per various Country Regulations in Shortest Possible Time and Cost-effective Way.

Sugam Portal Registration

Our Team of Experienced Professionals will be Happy to Serve you for Sugam Registration

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

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

License and Permission as per Medical Device Rules 2017 effective from 01 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