Medical device registration in India
In India, there are about 30 device “families” that outline which specific medical devices need to be registered.Before manufacturers of certain medical devices 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.
How to register for your medical device
Step 1
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.
Step 2
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.
Step 3
Some IVDs require in-country performance testing through the National Institute of Biologicals (NIB).*
Step 4
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).
Step 5
File registration applications with the CDSCO and pay fees. All documents must be in English.
Step 6
The CDSCO reviews applications and may require a Technical Presentation.** Novel devices will also undergo a Subject Expert Committee (SEC) review.
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.
Step 2
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.
Step 3
Some IVDs require in-country performance testing through the National Institute of Biologicals (NIB).*
Step 4
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).
Step 5
File registration applications with the CDSCO and pay fees. All documents must be in English.
Step 6
The CDSCO reviews applications and may require a Technical Presentation.** Novel devices will also undergo a Subject Expert Committee (SEC) review.
Step 7
The CDSCO will issue a Registration Certificate. The Certificate does not expire; however, registration maintenance fees are due every five years.
Step 8
Once approved, only your India Authorized Agent may import products. However, you can obtain multiple registrations for the same device through different Authorized Agents.
The CDSCO will issue a Registration Certificate. The Certificate does not expire; however, registration maintenance fees are due every five years.
Step 8
Once approved, only your India Authorized Agent may import products. However, you can obtain multiple registrations for the same device through different Authorized Agents.
Titansmedical can help you with medical device or IVD registration, act as your Authorized representative and support you with distributor identification and importation.
