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Regulatory Compliance

Admirus is a one-stop shop providing customized and methodical medical regulatory and compliance services to cut off the lead time and to speed-up the timely launch of your products. Our expertise with CDSCO and DCGI regulations will help you navigate the Indian regulatory system, achieve product registration, and access the huge Indian medical markets. Admirus will help you register your medical product in a cost-effective and timely way.

We offer consultancy services for the New Product Approvals, Import Registrations and Import Licenses in India for API’s, Drug Formulations, Diagnostic Kits, Surgical and Medical Implantable Devices.

Our team of experts includes health care professionals, regulatory compliance consultants and doctors. We focus on providing service in minimum possible time and cost.

 

The Indian regulator of pharmaceuticals and some medical devices is the Central Drug Standards Control Organization (CDSCO). CDSCO is also commonly referred to as the DCGI, which stands for Drug Controller General India.

All pharmaceuticals imported into India must have prior approval from the DCGI. There is no registration system designed for medical devices as a class, but some medical devices now require product approval as “drugs” before being marketed.

Our experienced professionals are familiar with all aspects of medical device regulatory compliance in India. Our services include obtaining Manufacturing License for medical devices in Form-28, medical device approval for foreign manufacturers in Form 40 and 44 and import licenses in Form 10.

Manufacturing License in form 28 (For Indian Manufacturer)
  • -   Providing guidance to develop your manufacturing premises as per Schedule M
  • -   Preparation of complete document.
  • -   Preparation and submission of application to CDSCO, Zonal and state drug controlling authorities.
  • -   Providing complete support during inspection and audit.
Medical Device Registration Certificate in Form 41 (For Foreign Manufacturer)
  • -   Determine 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).
  • -   Preparation of all necessary documents for the product registration application including Forms 40.
  • -   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.
Import License in Form 10
  • -   Determine 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).
  • -   Preparation 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.