India Approval Process for Medical Devices

Regulatory Process for Medical Devices and IVDs in IndiaBefore manufacturers of certain medical device can sell within India, they need to be in compliance with India’s minimal medical device regulations. India publishes a list of devices that require registration. The registration of these products is regulated under the provisions of the Drugs and Cosmetics Rules. 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.

Step 1
Is your product on the list below of Notified Medical Devices and IVDs which require device registration in India?

Blood Component Bags, Blood Grouping Sera, Bone Cements, Cardiac Stents, Catheters, Condoms, Disposable Hypodermic Needles, Disposable Hypodermic Syringes, Disposable Perfusion Sets, Drug Eluting Stents, Heart Valves, IV Cannulae, Internal Prosthetic Replacements, Intra Ocular Lenses, Intra Uterine Devices, IVD Devices for HIV, HBsAG and HCV, Orthopedic Implants, Scalp Vein Sets, Skin Ligatures, Surgical Dressings, Sutures and Staplers, Tubal Rings, Umbilical Tapes

Step 2
For medical device or IVD on list above, appoint an India Authorized Agent to interact with the Central Drugs Standard Control Organization (CDSCO) on your behalf. Your Agent must have a valid wholesale license (Forms 20B and 21B).

Step 3
For medical device or IVD on list above, grant your India Authorized Agent Power of Attorney to manage your registration in India.

Step 4
For medical device or IVD on list above, file application for Device Registration Certificate to CDSCO using Form 40. Schedules D-1 and D-2 must be included, as well as verification of compliance with US, Canadian, European, Japanese or Australian medical device regulations.

Step 5
For medical device or IVD on list above, device manufacturers new to India require a Form 45 (New Drug License) in support of the Form 40 application.

Step 6
For medical device or IVD on list above, obtain Registration Certificate Form 41 from CDSCO. Certificate is valid for up to 3 years.

Step 7
Identify your distributor in India (holding forms 20B and 21B).

Step 8
Apply for Import License using Forms 8 and 9 available from CDSCO. You must identify your chosen distributors on these forms.

Step 9
Obtain Import License (Form 10) from CDSCO. License valid for 3 years.

Step 10
You are now authorized to market your device in India.

© 2013 Emergo Group
Chart updated: 30/05/2013