India Officially Proposes Expansion of Regulatory Oversight to More Medical Devices

EMERGO SUMMARY OF KEY POINTS:

• Indian regulator CDSCO to formalize proposals to expand registration requirements to more types of medical devices.
• Affected manufacturers will have one year following publication of new requirements in the Gazette of India to comply.
• Types of devices to fall under CDSCO oversight include implantable devices, CT and MRI equipment and dialysis systems.

Medical device market regulators in India have officially identified which types of medical devices they plan to add to their list of healthcare products requiring registration.

An announcement from the Indian Central Drugs Standard Control Organization (CDSCO) states that the regulator will formalize recommendations from the Drugs Controller General’s (India) Drugs Technical Advisory Board (DTAB) to expand regulatory requirements to all implantable devices and other “high end equipment.” CDSCO plans to publish the new list of devices in the official Gazette of India; affected manufacturers will have 12 months from the date of that publication before the new rules come into effect.

Types of medical devices to fall under CDSCO oversight

CDSCO has specified which types of medical devices and equipment that would require registration in order to obtain Indian market authorization:

• All implantable devices
• CT scan equipment
• MRI equipment
• Defibrillators
• Dialysis machines
• PET equipment
• X-ray machines
• Bone marrow cell separators

Industry has 21 days from publication of the CDSCO announcement (June 22, 2018) to submit comments regarding the proposed changes.

Additional Indian medical device market information from Emergo:

• Indian CDSCO medical device registration consulting
• India Authorized Agent in-country representation