CDSCO Import License for Medical Devices in India (Quick Documentation and Approval)

CDSCO issues medical device import licenses under the Directorate General of Health Services in the Ministry of Health and Family Welfare.

Speed up your import licensing process with Operon Strategist, a leading CDSCO import license consultant who will assist you at every step of the medical device import license process.

CDSCO Import License for Medical Devices In India: An Overview

All Medical Devices importing to India must comply with the Indian Medical Device Regulation set forth by the CDSCO. The CDSCO is responsible for the approval and regulation of all medical devices and Clinical Trials in the Country, laying down the standards for Drugs, medical devices control over the quality of imported medical devices, and coordination of the activity of State Drug Control Organizations.

As per the new Guidance of CDSCO, suspension and cancellation of import for Class A, B, C and D medical devices may happen if importer fails to meet the deadline specified by CDSCO for mandatory Import license. CDSCO has set a complete procedure for granting licenses for medical devices imported in India. This procedure is applicable for all importers/distributors who import medical devices from other countries to India. However, all medical devices need to be classified according to the CDSCO classification rule. Earlier manufacturers were able to sell their medical devices in India without following any specific rules and regulations but from 2006, medical devices entering India need to follow specific import guidelines set by CDSCO.

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In India, several companies import raw materials, semi-finished goods, or components. To market these as finished medical devices, obtaining a CDSCO manufacturing license is mandatory for the final assembly and packaging processes within India.

CDSCO Import License Registration for Medical Devices

Pre-requisites for registration process:

Generic Name / Brand Name
Intended Use
Material of construction
Mode of application
Study of device details and Classification of medical devices on the basis of risk of product.

Latest CDSCO Update

India’s Directorate General of Health Services has initiated the National Single Window System (NSWS) Portal, in collaboration with TCS and Invest India, to simplify and streamline the approval process for the medical devices sector. Effective from January 1, 2024, stakeholders are advised to transition to this user-friendly portal, available at https://www.nsws.gov.in, as the existing cdscomdonline platform will be deactivated by January 15, 2024.

Know more: Government Launches NSWS Portal to Simplify Medical Devices Approvals

Regulations for CDSCO Import License for Medical Devices in India

CDSCO Import license for medical devices is regulated in India that any industry or an individual having license (wholesale Form 20/21 B and/or registration certificate to sell any medical device in India form 41/ 42 can apply for CDSCO import license under Central Drugs and cosmetics act, 1940 and can import any medical devices into India.

Foreign manufacturers have to appoint importer or authorized agents in India to register medical devices in India. The documents required for CDSCO import license registration have been clearly specified in the amendments. The validity of CDSCO import license will be 5 years from license issued.

CDSCO Import License Registration Phases for Medical Devices

As per CDSCO rule there is a certain mandatory requirement of regulatory certificate from foreign manufacturers to register medical devices in India.

Phase I – Applicant Registration:

For applicant registration to CDSCO portal, client will have an active account on CDSCO online registration portal .An authorized agent/distributor (who must have wholesale drug license form 20/21B or registration certificate form 41/42 to sell medical device in India) shall make an application for grant of CDSCO import license for medical device to the Central Licensing Authority through an identified online portal of the Ministry of Health and Family Welfare in the Central Government in Form MD-14 for obtaining a CDSCO Import license.

Procedure of Phase 1

Online form submission.
Submission of required document.
Approval from CDSCO.
If rejected, CDSCO will communicate the reason behind rejection or reapplication if necessary.

Phase II – Medical Device Import License Application:

Import license application is required to have permission to import medical devices for commercial purposes.

Procedure of Phase 2

Submission of online form with necessary details like classification of device, brand name, intended use, product description, etc.
Uploading the documents as per Indian CDSCO regulatory norm like regulatory certificate European CE, freesale certificate, ISO 13485, Plant Master file, Device Master file etc. .
CDSCO Fees to be paid as per product classification .
Application number will be generated after successful submission of all documents along with fee challan copy.

Phase III – Review from CDSCO

CDSCO will review the application along with verification of all documents which are uploaded and if any query is observed they will communicate.
Submitting relevant justification or revised documents to CDSCO online portal.

Phase IV– License Approval

CDSCO will review the justification along with verification of all documents and if it is as per CDSCO rule they will grant license.

How Operon Strategist Will Help You in CDSCO Import License Registration for Medical Device?

Operon strategist is the leading medical device regulatory consultant. Operon Strategist help manufacturers for obtaining various licenses required for importing and selling medical devices in India. These licenses include MD 14 license, MD 26 license, MD 42 license, and import license for medical devices. Operon Strategist assists clients starting from right classification of medical devices, generation of CDSCO login credential, preparation of all technical documents, review and uploading of all technical documents and guidance for online CDSCO fee payment for successful application. Operon strategist closely worked with CDSCO from the last 12 years and till date successfully completed 200 plus CDSCO registration. The Operon strategist technical team has inhouse capability to resolve CDSCO queries if any.

Operon Strategist Competencies

Operon Strategist guides and provides end to support to save clients’ commercial parts and efforts.
Operon Strategist also has a dedicated and experienced regulatory team.
Operon Strategist represents on behalf of clients for Audits of USFDA, ISO 13485 & European CE
Operon Strategist strategically works for quality service and timely execution of projects.

Get hassle-free and timely completion of projects get expert guidance and follow the correct procedure for achieving results.

Operon Strategist provides turnkey services, system implementation, training, licensing, regulatory approvals and certifications like FDA 510(k), European CE Marking, ISO 13485, SFDA, Egypt registration etc. Operon strategist has global presence in 32 countries like Saudi Arabia, the USA , Oman, Qatar, Japan, Philippines, China and Egypt etc. who like to import medical devices in India.

For the details of the CDSCO Import License, you can Contact Us or WhatsApp us at +91 9370283428.

FAQs

How can I import my medical device to India?

To import medical device in India one need to have registration certificate and importing license. To know more about CDSCO import license contact to our team.

What is the cost of an Import License for a medical device in India?

The CDSCO/Government fees will vary according to risk classification of medical devices. So, firstly the classification of medical devices is must and then our team can guide you about the best suitable and affordable cost for licensing process.

How can I get an Import License in India?

The importer should register with CDSCO first as the CDSCO grants the license application. After completing the necessary formalities and submissions, after reviewing application CDSCO either accepts or reject the proposal. To get Import license medical device regulatory consultants can help as they know the whole process and work closely with the various notified and certified body.

Where to apply for medical device import license?

For the licensing is regulated by the ministry of health and family welfare in the central government. The ministry has verified the CDSCO registration online portal through which the import license has to be made. The application is made to the central licensing authority using Form MD-14. The applicant should also submit some other documents along with the application Form for verification. Firstly the application must have a cover letter in a proper format having proper details for the application. The applicant needs to submit a valid manufacturer license of Indian agent for medical devices. This is the important condition for filling an application.

What is form MD-14 in CDSCO ?

To obtain an import license, it is necessary to complete the CDSCO application as per Form MD-14. In the case of a foreign manufacturer, the application must be submitted by an Indian-authorized agent or distributor. This Indian agent or distributor, representing foreign companies, must hold a valid wholesale license form 20B or 21B or registration certificate MD-41/42 that permits the sale of any medical device in India.

What is a CDSCO MD-15 license?

The MD-15 license refers to the CDSCO import license granted by the Central Licensing Authority. This MD-15 CDSCO import license is mandatory to import any medical device in India. In the case of a foreign manufacturer, an MD-15 license will be issued to an Indian authorized agent or distributor. The validity of the MD-15 license will be 5 years after the grant of the license.