How can I start manufacturing sterile medical devices in India?

In India majority of the medical devices packed and marketed in sterile condition, which are used in human beings or animals are known as Notified Medical Devices as per Ministry of Health and Family Welfare.

All Notified Medical Devices need a valid Licence to start manufacturing and selling. The following things to be taken care

  1. Build the manufacturing facility as per Schedule M III
  2. Take Layout Approval from state Govt.
  3. Compile all related statutory and regulatory requirements from Local, State and Central.
  4. Prepare Site Master File as per Schedule M III
  5. Submit Fee as per no of devices planned to manufacturer
  6. Application Filing with consent of Approved chemists
  7. Invite authorities for Inspection
  8. Acceptance of manufacturing Licence
  9. Start Manufacturing

To know more about Schedule M III or facility design, write to enquiry@i3cglobal.com  or Call + 91 80 5064 8432.

INDIA – Bangalore
+ 91 994 591 2081
Phone / Viber / WhatsApp


USA – Chicago
+1 630 696 1293
Phone / Viber / WhatsApp


mail enquiry@i3cglobal.com

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