Schedule M III

Schedule M 111 of the D&C Act exclusively details requirements of premises, plant and equipment needed to be evolved by the manufacturers of Medical Device in India during the course of manufacture or before setting up a new manufacturing unit.

Currently India has no specific regulations for medical devices except Implantable Devices, Critical Diagnostic Kits and other Sterile Devices. The list of products falls under this category are notified and these products are also called as drug and a valid license is required to start commercial production.

Entrepreneurs looking to setup new medical device manufacturing unit can utilize our consulting service available in all major cities in India.

  • Site approval
  • Facility Design
  • Environmental controls and Room book
  • Documentation and Validations
  • Training
  • Plan approval from state drug control departments.
  • Co ordination during regulatory Inspection

Schedule M 111 guidelines are essential pre requisites for maintenance of Quality of finished product. Each licensee is required to update these practices through appropriate methodology, systems, procedures, documentation, etc., in order to keep pace with the advances in technology.

India is all set to have regulatory standards like other major economic powers called as Indian conformity mark (IC Mark).

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