EMERGO SUMMARY OF KEY POINTS:

• New Indian Medical Device Rules will cover only those device types that already fall under CDSCO oversight.
• Existing Indian registrations will remain valid until 2020, according to informal discussions with the CDSCO.

India’s recently published Medical Device Rules 2017 (link goes to PDF list of regulations), set to take effect in 2018, will likely pertain only to devices that are currently regulated by the Central Drugs Standard Control Organization CDSCO).

New medical device regulations keep existing scope in place

According to informal discussions between Emergo consultants and CDSCO officials, no new device types except those updated “from time to time” will fall under Medical Device Rules requirements. This may clear up a major question as to the scope of the new regulations and which types of devices would fall under new Indian registration requirements.

Existing CDSCO registrations good through 2019

Furthermore, device registrations obtained under the existing Indian registration system will remain valid until 2020; foreign manufacturers may still register under the current system through January 1, 2018.

However, Emergo consultants in India will continue to monitor the situation and communicate with CDSCO regulators to update this information.

For information on India’s existing registration system, including which devices must register with the CDSCO, download our regulatory process chart.