The new Medical Device Rules, 2017 significantly expands the number of IVD devices requiring full technical documentation in support of their registration applications. Formerly only the 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, a risk-based classification is provided for IVD devices and all test kits must obtain Form MD 15 prior to importation.
Required elements of the 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. Further, performance evaluation reports from the National Institute of Biologicals (NIB) are required for HIV, HBsAg, HCV and blood grouping sera tests. Seven other IVD tests (i.e., Malaria, Dengue, Chikungunya, Syphilis, Typhoid, Tuberculosis, Cancer markers) require performance evaluation reports from a local National Accreditation Board for Testing and Calibration Laboratories (NABL) accredited laboratory.
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 TypePlant Master FileDevice Master File
A IVD Device US$1,000 US$10
B IVD Device US$1,000 US$10
C IVD Device US$3,000 US$500
D IVD Device US$3,000 US$500
Asia Actual can manage and submit Import License applications and local performance testing to ensure the efficient, timely and secure issuance of certificates.