New medical device regulations came into effect on January 1, 2018. Currently only 22 types of medical and IVD devices are required to be registered with India’s Central Drugs Standard Control Organization (CDSCO) prior to being placed on the market. Guidance on which devices require India medical device registration is provided through DCG(I) Notice 29/Misc.l3/2017-DC(292) (copy available here).
Asia Actual can confirm if registration is required for your device(s), identify the number of registration applications necessary to cover all models of interest (product grouping) and manage the registration process through timely, successful completion.
Prerequisites for India medical device registration include:
Reference country approval
ISO 13458 certification of the manufacturing facility.
As such, the registration process in India for imported devices is a re-assessment largely utilizing the same documentation and evidence required in the reference country review. The CDSCO fees for application processing which takes 6 to 9 months depends on device classification (as per the table below). Successful applicants will be issued an Import License (aka MD Form 15) which does not expire if listing fees are paid every 5 years.
Classification Type Plant Master File Device Master File
A Medical Device US$1,000 US$50
B Medical Device US$2,000 US$1,000
C Medical Device US$3,000 US$1,500
D Medical Device US$3,000 US$1,500
Medical devices that are novel to the Indian market in terms of materials, mode of action or intended use are considered ‘investigational devices’ and subject to additional clinical investigation requirements and review including establishing safety and effectiveness through clinical investigation in India.
Contact Asia Actual for assistance with Medical Device Regulations in India.