Medical Devices and In-Virto Diagnostics

Global Medical device and IVD Regulatory & Market Access Services (Including India)

IPHARMED provides regulatory consulting services for every step of the medical device product lifecycle, developing the optimal strategy depending on the device and market focus.

1) US, EU, and Core Global Services

  • EU MDR Transition Support and Gap Assessments
  • Gap Assessment for 510(k) or CE Marking documentation to include assessment for Device classification, TF documentation, TF PMS, GSPRs, IFU.
  • Authoring BERs, CERs for all classes of device.
  • Post-Market Clinical Follow-up study design, and data analysis.
  • Implementation of Unique Device Identification (UDI) and EUDAMED.
  • Creation and updation of PMS and PSUR.
  • Biocompatibility and Risk Assessments.

2) Global Regulatory Intelligence

  • Regulatory Intelligence on country-specific requirements, product classification, clinical trial study requirements, and import regulations across major markets (including the CDSCO in India, FDA in the US, and Notified Bodies in the EU).

3) India Market Access & CDSCO Support

  • CDSCO Compliance Strategy: Developing a clear path for device classification (Class A, B, C, D) and compliance with the Medical Devices Rules, 2017.
  • Import/Manufacturing License Filings: Preparation and submission of applications via the CDSCO’s SUGAM online portal, including:
    • Form MD-14 (Application for Import License)
    • Form MD-7/MD-8 (Application for Manufacturing License)/li>
  • Master File Authoring: Creation of comprehensive technical documentation required for the application process:
    • Device Master File (DMF) (Product-specific technical dossier)
    • Plant Master File (PMF) (Detailed document describing the manufacturing facility’s Quality Management System)
  • In-Country Regulatory Agent Support: Assistance with appointing and liaising with the mandatory Authorized Agent for foreign manufacturers, who handles communications with the CDSCO and holds the necessary wholesale license.
  • Local Labeling Requirements: Ensuring device labeling complies with the specific requirements of the MDR 2017.