The Central Drugs Standard Control Organisation (CDSCO) functions as India’s National Regulatory Authority under the Ministry of Health and Family Welfare. Governed by the Drugs and Cosmetics Act, obtaining a CDSCO import license for medical devices is essential to ensure adherence to regulations that safeguard patient safety and well-being.
According to the Medical Device Rules 2017, medical devices includes a diverse array of items including:
- In-vitro diagnostic substances.
- Surgical dressings.
- Contraceptives.
- Disinfectants.
- Devices utilized for the diagnosis, treatment, or prevention of diseases in humans and animals.
Role of CDSCO in Import Licensing:
CDSCO oversees the approval of new drugs, conducts clinical trials and establishes standards for the import licensing of medical devices. The organization is committed to maintaining transparency, accountability and quality in the medical products available in India. Key functions of CDSCO import registration include:
- Issuing registration certificates for bulk drugs and finished products.
- Granting import licenses for medical devices in Form 10 or Form 10A.
- Issuing No Objection Certificates (NOCs) for shelf-life extensions.
- Processing post-approval modifications.
- Coordinating with zonal/sub-zonal offices for the importation of chemical drugs.
These regulations are designed to ensure that imported medical devices comply with safety and quality standards as mandated by the Central Drugs and Cosmetics Act of 1940 and the Medical Device Rules 2017. Additionally, foreign manufacturers must designate an authorized agent in India to facilitate the import license application.
Securing a CDSCO import license for medical devices provides several advantages:
- Assurance of compliance with applicable laws and regulations.
- Guarantees product safety and quality.
- Expands market opportunities.
- Enhances consumer protection by upholding quality standards.
These devices are categorized into four risk-based classes:
- Low Risk - Class A.
- Low Moderate Risk - Class B.
- Moderate High Risk - Class C.
- High Risk - Class D.
Licensing Authorities:
The licensing authorities responsible for CDSCO import registration include:
- State Licensing Authority (SLA): Issues licenses for Class A and B medical devices.
- Central Licensing Authority (CLA): Issues licenses for Class C and D devices, as well as cosmetics.
Requisites for CDSCO License Registration:
To obtain a CDSCO import license, the following requisites are essential:
- Unique generic brand name for the device.
- Comprehensive description of the device.
- Details of safety measurements.
- Intended mode of application.
- Risk classification study.
Required Documentation for CDSCO Import License:
The necessary documentation for import license registration includes:
- Covering letter.
- Authorization letter from the company’s director or secretary.
- Completed Form MD-14.
- Notarized Form 9.
- Valid Form 41 registration certificate.
- Wholesale license for drug distribution.
- Free Sale certificate from the country of origin.
- Manufacturing license from the country of origin.
For a customized and attractive quotation, please contact with your product details to Rekha Atri (+91 98118 03136) or Manju Laur (+91 9711994042).
Process for Obtaining a CDSCO Import License:
The online application process for a CDSCO import license involves the following steps:
- Visit the SUGAM portal.
- Submit Form MD-14 along with the required documents and fees.
- Application review by Drugs Inspectors.
- Evaluation and forwarding by the Deputy Drugs Controller to the Joint Drugs Controller.
Note : Final approval or rejection by the Drug Controller General of India.
