India’s total medical device market is currently $5.2 Billion USD, and imports are 75% of the total market. India’s medical device market is expected to grow due to increased health awareness, a growing middle class, and government health initiatives.
The Central Drugs Standard Control Organization (CDSCO) of India regulates all medical devices. Prior to 2017, most of the regulated devices are non-electrical in nature. In 2017, authorities published the Medical Device Rules and it came into force in 2018. Initially, the devices below made up the list of products requiring mandatory CDSCO registration:
- Blood Pressure Monitoring Device
- Digital Thermometers
Manufacturers selling any of the medical devices listed above will have to register with CDSCO by January 1st, 2020!
In addition to those, CDSCO has recently added the following devices to the list:
- All Implantable Medical Devices
- CT Scan Equipment
- X-Ray Machine
- MRI Equipment
- Dialysis Machine
- Bone Marrow Cell Separator
- PET Equipment
Manufacturers selling any of the medical devices listed above will have to register with CDSCO by April 1st, 2020!
Determining if your product is regulated by the CDSCO is the first step in selling medical devices in India. Manufacturers interested in registering their medical devices in India must supply proof of approval in their home market.
If your device requires CDSCO registration, G&M is able to provide services to streamline the registration process. Our local team in India works closely with CDSCO to provide the following:
- Determine if the medical device falls under regulated medical device categories
- Based on the product risk class, prepare necessary documents for registration
- Assist with and buffer communication between the manufacturer and CDSCO
- Provide local representative service (if manufacturer does not have a registered Indian company)
- Depending on risk class, assist with factory inspection audits
If you need more information on or assistance in obtaining CDSCO registration, please contact G&M Compliance or call us at 714-628-1020.