Medical Devices and In-Vitro Diagnostics

Medical Devices and In-Vitro Diagnostics

Activities for Manufacturers

  1. Various QMS Systems Development and Implementation with respect to
    • MDR 2017
    • ISO 13485
    • CE Marking under EU MDR
    • 510k under 21 CFR 820 (USFDA)
  2. Applications for Manufacturing Test license under Form MD 12 (Medical Devices/IVDs) – CDSCO
  3. Applications for Manufacturing License under Form MD 9 (Medical Devices/IVDs) – CDSCO
  4. Applications for Manufacturing License under Form MD 5 (Medical Devices/IVDs) – SLA
  5. Applications for Loan License
  6. Applications to Conduct Clinical Investigations for Manufacturing of New Medical Devices under Form MD 22– CDSCO
  7. Applications to Conduct Clinical Investigations for Manufacturing of New IVDs under Form MD 24– CDSCO
  8. Applications for Manufacturing of New Medical Devices under Form MD 26
  9. Applications for Manufacturing of New IVDs under Form MD 28– CDSCO
  10. Applications for Various Certificates like Free sales certificate-CDSCO, Market Standing Certificate-SLA, Neutral Code-CDSCO, Non-Conviction Certificate-SLA etc for Medical Devices and IVDs.

Activities for Importers

  1. Applications for Import Test license under Form MD 16 (Medical Devices/IVDs) -CDSCO
  2. Applications for Import license under Form MD 14 (Medical Devices/IVDs)- CDSCO
  3. Applications to Conduct Clinical Investigations for Import of New Medical Devices under Form MD 22-CDSCO
  4. Applications to Conduct Clinical Investigations for Import of New IVDs under Form MD 24-CDSCO
  5. Applications for Import of New Medical Devices under Form MD 26-CDSCO
  6. Applications for Import of New IVDs under Form MD 28-CDSCO
  7. Applications for Various Certificates like Free sales certificate, Market Standing Certificate, Neutral Code, Non-Conviction Certificate etc for Medical Devices and IVDs. –CDSCO

Know more services

Plan Design and Development

(Pharmaceutical APIs and/or Pharmaceutical Formulations compliance to WHO-GMP/PICS/EUGMP/UK MHRA)

Pharmaceuticals formulation and Active Pharmaceuticals Industries

Various Regulatory Services concerning to the State Licensing Authorities (SLA)

Various Regulatory Services concerning to the Central’s Zonal Licensing Authorities (CLA-Zonal CDSCO)

Cosmetics

Applications for Manufacturing License under COS 5

Applications for Additional Product Approvals