Central Drugs Standard Control Organization, commonly known as CDSCO is an Indian regulatory body for the medical device industry, under regulatory provisions of the Drugs & Cosmetics Act 1940 & Rules 1945.
The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian medical devices and pharmaceuticals. It is a licensing authority which approves any new chemical entity (drug) to import to India.
Every nation in the world have their own dedicated governing body under the ministry of health to look after every aspect of pharmaceutical and medical devices.
The CDSCO is responsible for regulating the registration & sale of notified medical devices in India.
CDSCO 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 (CDSCO) is located in New Delhi, India
It has six zonal offices, four sub-zonal offices, thirteen Port offices and seven laboratories spread across the country.
- 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 Cements
- Blood Component Bags
- Cardiac Stents
- 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.
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
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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.
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