At the July 25th Drugs Technical Advisory Board (DTAB) meeting, a resolution passed to add (1) glucometers, (2) blood pressure monitoring devices, (3) nebulizers, and (4) digital thermometers to the list of notified medical devices requiring registration with the Central Drugs Standards Control Organization (CDSCO) in India.

Next the Ministry of Health and Family Welfare must issue a Gazette Notification for the requirement to become official. Based on past experience,  it is expected to take approximately 5 months from a positive DTAB board resolution to Notification with a likely 12-month transition period for compliance. Manufacturers of these devices should take urgent action to prepare registration applications to maintain access to the Indian market.

This is the third Notification announcement since the Medical Device Rules, 2017 were enacted on January 1st of this year. The decisions are coming with increased frequency, so manufacturers of non-Notified devices are advised to stay alert for announcements and make early registration preparations.

Asia Actual has a strong regulatory team in Delhi to help companies stay informed and ahead of regulatory changes.

We also provide efficient, transparent management of medical device regulatory, vigilance and importing activities in this dynamic market.

Please contact Asia Actual with questions or service inquiries.