The new Medical Device Rules, 2017 that took effect January 1, 2018 significantly expands the number of IVD devices requiring full technical documentation in support of their Import License applications. Formerly only 4 critical IVD devices required registration with complete Device Master  File with the Central Drugs Standard Control Organization (CDSCO) prior to being placed on the market in India.  Under the new Rules, all reagents and test kits must obtain MD Form 15 prior to importation, however any IVD device covered by an Import License (Form 10) granted under the old Rules will remain valid until the expiry date (maximum validity of three years).

Required elements of the new registration application include: 1) proof of reference country approval, 2) ISO 13485 certification of the manufacturing facility, and 3) full technical details as per the prescribed requirements of the device master file.

More time, effort and expense will be required for most IVD reagent and test kits to maintain or gain market access.

Further, performance evaluation reports from the National Institute of Biologicals (NIB) are required for HIV, HBsAg, HCV and blood grouping sera tests as before. Seven other IVD tests (i.e., Malaria, Dengue, Chikungunya, Syphilis, Typhoid, Tuberculosis, Cancer markers) that formerly required performance evaluation reports from a local National Accreditation Board for Testing and Calibration Laboratories (NABL) accredited laboratory, now required the same for the NIB.

The CDSCO processing fees vary by risk classification as per the table below.  Processing times are expected to take 6 to 9 months.  Successful applicants will be issued an Import License (aka MD Form 15) which is valid for perpetuity, with retention fees due every five years.

Classification Type                Plant Master File       Device Master File