The Medical device industry in India is regulated by Central Drugs Standard Control Organization (CDSCO) under the regulatory provisions of the Drugs &Cosmetics Act 1940 & Rules 1945.
The CDSCO is responsible for regulating the registration & sale of notified medical devices in India.
We also help companies get the wholesale license to facilitate the sale of their products in India. The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals & medical devices.
The Central drug standard control organization (CDSCO) is the national regulatory body or licensing authority for Indian pharmaceuticals and medical devices.
CDSCO is controlled and governed by Directorate General of Health Services which comes under the ministry of health and family welfare, Government of India. The headquarter of the Central Drugs Standard Control Organization is located in New Delhi.
CDSCO has six zonal offices, four sub-zonal offices, thirteen Port offices and seven laboratories spread across the country.
Medical Device Registration and CDSCO approval process In India
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.
medical device or IVD on the 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).
medical device or IVD on the list above, grant your India Authorized Agent Power of Attorney to manage your registration in India.
medical device or IVD on the 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.
medical device or IVD on the list above, device manufacturers new to India require a Form 45 (New Drug License) in support of the Form 40 application.
medical device or IVD on the list above, obtain Registration Certificate Form 41 from CDSCO. The certificate is valid for up to 3 years.
Identify your distributor in India (holding forms 20B and 21B).
Apply for Import License using Forms 8 and 9 available from CDSCO. You must identify your chosen distributors on these forms.
obtain Import License (Form 10) from CDSCO and CDSCO License valid for 3 years.
You are now authorized to market your device in India.
Name: ISO 13485 Consultant