June 12, 2018

The regulatory standards for the approval of IVD devices keep on changing time to time because of the continuous improvements and modifications made related to their better performance level. There was a revision for “glucometer test strips” in 2013 as mentioned in IS/ISO 15197: 2013. The effective date of implementation of this revised standard “IS/ISO 15197: 2013” shall be October, 18, 2019.

MTAI (Medical Technology Association of India) made this query asking the exact date of implementation of “IS/ISO 15197: 2013” related to “Glucometer test strips”. As answer, CDSCO mentions that the revision would be implemented after 36 months from the date of establishment of this standard by BIS (Bureau of Indian Standards), which was done on October 19, 2016 in the notification vide S.O. 3259 by BIS. Hence the effective implementation date of this revised standard for glucometer test strips shall be October, 18, 2019.

Reference:

Applicability of IS/ISO 15197 2013 version regarding glucometer test strips