Before manufacturers of certain medical device can sell within India, they need to be in compliance with India’s medical device regulations. Indian authorities overhauled the medical device regulatory process in 2017 with the publication of the Medical Device Rules. The rules came into force in January 2018 and devices are regulated by the Central Drugs Standard Control Organization (CDSCO), an agency of the Ministry of Health and Family Welfare. For an overview of the regulatory process, see or download the approval chart below.
India’s medical device approval process explained
The chart shown illustrates India’s approval process and is available for download in PDF format. However, if you would like to explain the steps to someone else in an email, you can cut and paste the text below or send them a link to this page.
Medical devices and IVDs are regulated by the Drug Controller General of India (DCGI) within the Central Drugs Standard Control Organization (CDSCO), part of the Ministry of Health and Family Welfare. The regulatory framework for medical devices is based on the Medical Device Rules, 2017. Only a limited number of medical devices and IVDs require registration in India. A full list can be found in the CDSCO’s List of Medical Devices and In Vitro Diagnostics Along with their Risk Class.
Appoint an India Authorized Agent to interact with the CDSCO on your behalf. Your Agent must have a valid wholesale license (Forms 20B and 21B/21C), and be granted Power of Attorney to manage your registration and device importation in India.
Some IVDs require in-country performance testing through the National Institute of Biologicals (NIB).*
Compile device application (Form MD-15), including manufacturing facility information, device technical information, ISO 13485 certificate, IFU, testing results (if applicable), clinical data (if applicable), proof of approval in the US, EU, Australia, Canada, or Japan, plus proof of approval in your home country (satisfied by CFS/CFG).
File registration applications with the CDSCO and pay fees. All documents must be in English.
The CDSCO reviews applications and may require a Technical Presentation.** Novel devices will also undergo a Subject Expert Committee (SEC) review.***
The CDSCO will issue a Registration Certificate. The Certificate does not expire; however, registration maintenance fees are due every five years.
Once approved, only your India Authorized Agent may import products. However, you can obtain multiple registrations for the same device through different Authorized Agents.
© 2018 Emergo by UL
Chart updated: 12/10/2018