Jun 27, 2018
EMERGO SUMMARY OF KEY POINTS:
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.
CDSCO has specified which types of medical devices and equipment that would require registration in order to obtain Indian market authorization:
Industry has 21 days from publication of the CDSCO announcement (June 22, 2018) to submit comments regarding the proposed changes.
EMERGO SUMMARY OF KEY POINTS:
EMERGO SUMMARY OF KEY POINTS: