On December 27th, the CDSCO announced new registration deadlines for several medical devices will be postponed from January 1st 2020 to January 1st 2021.

Affected devices are:

  • Nebulizers
  • Blood Pressure Monitoring Devices
  • Digital Thermometers
  • Glucometers

As a result, medical device manufacturers now have 12 months before a Form MD-15 (Import License) will be required for the devices to clear Indian Customs. With government review guidance at 6 to 9 months, applications should be prepared for submission no later than March 1st, 2020 to safely avoid losing market access.

Similarly, registration deadlines for another set of medical devices will be postponed from April 1, 2020 to April 1, 2021. Affected devices are:

  • CT Scan Equipment
  • MRI Equipment
  • Defibrillators
  • Dialysis Machines
  • PET Equipment
  • X-Ray Machines
  • Bone Marrow Cell Separators
  • All Implantable Medical Devices

Medical device manufacturers have 15 months before a Form MD-15 (Import License) will be required for the devices to clear Indian Customs. With government review guidance at 6 to 9 months, applications should be prepared for submission no later than July 1st, 2020 to safely avoid losing market access.

No such postponement announcement has yet been made for ultrasound devices which are due to require an Import License by November 1st, 2020.

Asia Actual has a strong regulatory team in India helping companies stay informed and navigate the regulatory changes in India’s dynamic and complex market. Contact Asia Actual for questions or service regarding your medical device registration requirements.