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.
Frequently Asked Questions
The Central Drugs Standard Control Organization (CDSCO) is India's National Regulatory Authority under the Ministry of Health and Family Welfare. It is responsible for regulating medical devices to ensure their safety quality and efficacy. Medical device registration with CDSCO is mandatory for manufacturers and importers to legally market and sell their devices in India, protecting public health and ensuring compliance with the Drugs and Cosmetics Act and Medical Device Rules.
The Medical Devices Rules, 2017 define a broad range of items as "medical devices," including:-
• In-vitro diagnostic substances.
• Surgical dressings.
• Contraceptives.
• Disinfectants.
• Devices used for diagnosis, treatment or prevention of diseases in humans or animals.
Essentially, any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article intended by the manufacturer to be used alone or in combination, for humans or animals for one or more of the specific medical purposes.
Medical devices in India are classified as:-
• Class A: Low Risk.
• Class B: Low-Moderate Risk.
• Class C: Moderate-High Risk.
• Class D: High Risk.
The classification determines the regulatory requirements and the licensing authority.
Typically, the following entities are involved in the CDSCO registration process:-
• Manufacturers: Both domestic and foreign manufacturers of medical devices.
• Importers: Entities that import medical devices into India.
Foreign manufacturers are usually required to appoint an Authorized Agent in India to facilitate the registration process.
Obtaining CDSCO registration offers several advantages:-
• Legal Market Access: Allows you to legally sell and market your medical devices in the Indian market.
• Regulatory Compliance: Ensures adherence to Indian laws and regulations, avoiding penalties and legal issues.
• Enhanced Credibility: Builds trust with healthcare professionals and consumers, showcasing your commitment to safety and quality.
• Market Expansion: Opens up opportunities to tap into the growing Indian healthcare market.
The general process for obtaining a CDSCO import license involves:-
1. Preparation of Documentation: Compiling all the necessary technical and regulatory documents.
2. Online Application Submission: Submitting the application through the designated CDSCO online portal (e.g., SUGAM).
3. Application Review: CDSCO authorities review the submitted application and documentation.
4. Query Resolution: Addressing any queries or requests for additional information from CDSCO.
5. License Grant: Upon successful review, CDSCO grants the import license.
The required documents can vary depending on the device classification. However, some common documents include:-
• Manufacturing license from the country of origin.
• Device description and specifications.
• Safety and performance data.
• Clinical trial data (if required).
• Quality management system (QMS) information.
• Labeling and packaging information.
• Post-market surveillance plan.
• And other documents as per CDSCO guidelines.
iKargos can provide a detailed document checklist tailored to your specific device.
The fees and timelines for CDSCO registration may vary based on the device classification and the complexity of the application. Contact iKargos for a customized quotation and timeline estimate.
The validity of the CDSCO registration can vary. It's essential to confirm the current validity period with CDSCO regulations or through consultation with iKargos. Re-registration is required to continue marketing the device in India.
Some common challenges include:-
• Complex regulatory requirements.
• Extensive documentation requirements.
• Navigating the CDSCO portal and processes.
• Meeting timelines and addressing queries effectively.
iKargos can help you overcome these challenges by providing:-
• Expert guidance on regulatory pathways.
• Assistance with document preparation and submission.
• Management of the entire registration process.
• Effective communication with CDSCO authorities.
Yes, iKargos can facilitate the CDSCO registration process including assisting with the Authorized Agent requirements.
To begin your CDSCO medical device registration journey with iKargos, please contact our dedicated team:-
• Rekha Atri: +91 98118 03136.
• Manju Laur: +91 9711994042.
• Kapish Laur: +91- 99717 70603.
