• Phone: +91 98198 93250
  • Email: info@marksbiotech.com

DEVICE REGISTRATION & NEW MARKET ENTRY

Device Registration

  • India CDSCO Medical device registration and approvals
  • IN country representation

Indian Market Entry for Medical Devices requires to obtain registration and approvals from the registration agencies and in India it is CDSCO (Central Drug Standard Control Organisations).

Based on the product classifications registration requirements and work related may vary to make premarket technical and clinical submission or leveraging existing registration and approvals for availing faster entry to new markets launches

New Market Entry Support Services

  • Product Registration with Ministry of Health Authorities for Licenses
  • Imports & Registration of Plant and Products
  • Create a Regulatory strategy
  • Pre-Screening of Documents
  • Timeline Management
  • Global Clinical Trails
  • FDC Approvals
  • CE Mark Approvals

Identification of Right Channel Partners for our Clients for South Asia Markets

  • Work with Channel Partners in branding and marketing campaigns including Clinical Training & Education of products and skill enhancement
  • Post Market Surveillance