CDSCO Roles

Approval of new drugs and clinical trials.

Import CDSCO registration & licensing.

Licensing of blood banks, vaccines and some medical devices.

Amendment to Drugs & Cosmetics Act and rules.

Participation in WHO GMP certification schemes.

Grant to test license, personal license, NOC’s for export.

Testing of drugs by central labs



Medical Devices Notified by CDSCO before 1st Jan 2018

Blood Grouping Sera

Bone Cement

Blood Component Bags

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.

CDSCO has released a new list of notified medical devices and IV devices, amended in June 2018. This list consists of more than 450 medical devices and 200 IVD products. New notification of CDSCO includes the list of more medical devices that would be regulated by 1st May 2020. Follow our updates on Linkedin for the latest information and keep yourself informed about CDSCO Regulatory news and alerts. You can also contact us for any assistance or for a specific query.

CDSCO Guidelines & Medical Device Registration

Step 1: Check if the product you wish to register is on the Notified Medical Devices and IVDs list.

Step 2: Contact an authorized agent, having a license for manufacture, distribution and/or wholesale license for sale can make an application for grant of import license for the medical device to the Central Licensing Authority

We at Operon Strategist walk with you throughout the process to help you get the required license smoothly. Contact us today

Step 3: Next step is to submit the application and specified fees for the process.

Step 4: After examination of documents furnished with the application and on the basis of the inspection report, if an inspection has been carried out, the Central Licensing Authority may, on being satisfied, grant license in Form MD-15

Step 5: License can be granted without clinical investigation if free sale certificate is been issued for any medical device by any of the National regulatory or other competent authority of countries like Australia, Canada, Japan, EU Nations, or the United States.

Step 6: If medical device imported from countries other than mentioned above (in step 5), license for Class C and Class D medical device can be granted after clinical investigation for safety and effectiveness.

Step 7: If medical device imported from countries other than mentioned above (in step 5), license for Class A or Class B medical devices may be granted after its safety and performance has been established through published safety and performance data, It can be granted on basis of clinical investigation and free sale certificate from the country of origin.

Step 8: In case of an investigational medical device or new in vitro diagnostic medical device, the applicant should obtain prior permission for it through “form MD-27 or Form MD-29” from the Central Licensing Authority, without such prior permission medical device license may not be granted.

How Operon Strategist Assist you in CDSCO Application process?

When it comes to CDSCO medical device license process, Operon strategist makes the lengthy process easy and smooth with the best technical team working for you, along with excellent assistance, timely responses and affordable fees structure. Extensive experience in Regulatory consulting, medical device certification makes Operon strategist best regulatory Consultant. Contact us for all types of medical device consulting services and we will be always there to assist you.