EMERGO SUMMARY OF KEY POINTS:

• Draft CDSCO list clarifies medical device and IVD types notified for Indian market registration
• More types of IVD products would fall under Medical Device Rules 2017 notification requirements
• Formal inclusion of devices requiring registration but not previously added to notification list

Indian medical device market regulators have published a new draft list of medical devices that clarifies how they’ll be classified under the new Medical Device Rules 2017.

The Central Drugs Standard Control Organization’s (CDSCO) list does not appear to add any new medical devices to the 15 devices currently notified for mandatory registration in India, but the regulator appears to have broken down larger groups of devices such as “cannulas” and “stents” into more specific sub-groups such as “ureteral stents” and “coronary stents.” CDSCO has classified these new sub-groups using risk assessment methods required by the Medical Device Rules 2017, still slated for early 2018 implementation.

New IVDs added to list of notified devices

Although it appears as though CDSCO has not added any additional medical devices to its notified list, the regulator seems to have added more IVD products to that list.

Previously, IVDs for HIV, Hepatitis B and C and Blood Grouping Sera fell under Indian notification and registration requirements; in the new draft list, IVDs such as those for congenital and autoimmune disorders, genetic testing and sexually transmitted infections would also require notification.

Furthermore, the list specifies certain IVDs—those for malaria, dengue, chikungunya, syphilis, typhoid, tuberculosis, cancer markers and blood glucose—that would require import licenses and/or performance evaluations in order to obtain Indian market authorization.

Clarifications on which devices require CDSCO registration

In addition, the draft list includes medical devices that heretofore had not been included on the CDSCO list of notified products but had nonetheless required registration for sale in India. The new list would formally include these devices, which include HA filters and electrodes, among notified products.

Work in progress

According to Emergo consultants in New Delhi and Secunderabad, Indian regulators will issue additional drafts of medical device classification lists over the next few months.

Indian medical device regulatory resources:

• CDSCO registration and approval support for medical device companies
• India Authorized Agent in-country representation for foreign companies
• India regulatory process chart
• Video overview: India’s medical device approval process