Businesses intending to manufacture medical devices in India must obtain Medical Device Registration from the Central Drugs Standard Control Organisation (CDSCO). This registration is issued by either the CLA or SLA, depending on the risk classification of the medical devices. Medical devices in India are categorized into four classes based on their associated risks:
- Class A includes devices with low risk, such as thermometers and sphygmomanometers.
- Class B comprises devices that pose low to medium risk, such as needles and suction cannulae.
- Class C includes devices with medium to high risk, such as ventilators and joint implants.
- Class D covers devices with high risk, such as pacemakers and heart valves.
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Email: cs@absoluteveritas.com
CDSCO Import License for Medical Devices In India
Overview
All medical devices imported into India must adhere to the regulations outlined by the CDSCO (Central Drugs Standard Control Organization). CDSCO oversees the approval and regulation of medical devices and clinical trials within the country, establishing standards for drugs and ensuring control over the quality of imported medical devices. Additionally, CDSCO coordinates with State Drug Control Organizations to streamline regulatory activities.
Under the latest CDSCO guidelines, importers of Class A, B, C, and D medical devices risk suspension or cancellation of imports if they fail to meet CDSCO's mandatory import license deadlines. CDSCO has established a comprehensive procedure for granting licenses to import medical devices into India. This procedure applies to all importers and distributors bringing medical devices from overseas into India. Additionally, all medical devices must undergo classification according to CDSCO rules. Previously, manufacturers could sell medical devices in India without adhering to specific regulations, but since 2006, imported medical devices must comply with stringent import guidelines set by CDSCO.
CDSCO Import License Registration for Medical Devices
Pre-requisites for registration process of CDSCO for Medical Devices:
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Generic Name / Brand Name
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Intended Use
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Material of construction
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Mode of application
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Analysis of device specifications and Risk-based classification of medical devices
Who Can Apply for CDSCO Registration in India?
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Domestic Manufacturers of Medical Devices/IVDs
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Importer of Medical Devices/IVDs/Cosmetics
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Foreign Manufacturer of Medical Devices/IVDs/Cosmetics
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Authorised Agent of Medical Devices/IVDs/Cosmetics
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Indian Subsidiary of Medical Devices/IVDs/Cosmetics
Sample of Import License for CDSCO for Medical Devices
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Regulatory Guidelines for CDSCO Import Licenses for Medical Devices in India
The CDSCO import license for medical devices in India is governed by regulations that allow any industry or individual holding a license (such as wholesale Form 20/21 B or registration certificate Form 41/42 to sell medical devices in India) to apply for import licenses under the Central Drugs and Cosmetics Act, 1940. This enables the importation of medical devices into India.
Foreign manufacturers must appoint importers or authorized agents in India to register medical devices. The documents necessary for CDSCO import license registration are clearly outlined in recent amendments. The CDSCO import license is valid for 5 years from the date of issuance.
Market Overview and Growth Opportunities
As of May 2021, India ranks as the fourth largest medical devices market in Asia, estimated at approximately US$ 12 billion, with an import reliance ranging between 75% to 80%.
The Indian in-vitro diagnostics market is projected to achieve a value of US$ 2060 million by 2027, showing an anticipated compound annual growth rate (CAGR) of 7.5% from 2020 to 2027.
India stands as one of the leading global markets for cosmetic products, boasting an import value nearing US$ 60 million and anticipating a CAGR of 4.23% from 2022 to 2024.
The Indian markets for medical devices, in-vitro diagnostic devices, and cosmetics present significant opportunities for manufacturing and import businesses. Factors such as evolving health standards, rising income levels, increased consumer awareness, and improved lifestyles are anticipated to drive demand for these products in the foreseeable future. New enterprises can capitalize on these opportunities by obtaining CDSCO registration and other required approvals from relevant licensing authorities.
Need for CDSCO Registration
CDSCO registration not only provides legal validity but also enhances customer confidence in a brand. Here are key reasons why CDSCO registration is essential for businesses dealing with medical devices, IVDs, and cosmetics:
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To enhance brand reputation and appeal to a broader customer base.
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To adhere to regulatory requirements for manufacturing, selling, distributing, or importing these products.
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To ensure the safety and quality standards of products provided to customers.
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To mitigate legal and penalty risks linked to post-licensing compliance and audits.
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To access innovations and high-quality products available internationally.
Types of CDSCO Registration in India
Medical Devices Registration +
Medical Devices Import License +
According to the Medical Devices Rules of 2017, obtaining a Medical Device Import License is mandatory for importing any notified medical devices. Businesses seeking to import medical devices must appoint an Authorized Agent in India and provide requisite approval certifications like CE certification, FDA Approval, EN certification, ISO certification, etc.
In-Vitro Diagnostic Device Manufacturing License+
Manufacturers intending to produce in-vitro diagnostic medical devices in India must first secure an IVD manufacturing license from CDSCO. In-vitro devices encompass kits, reagents, instruments, and systems utilized for diagnosing diseases or health conditions, including those used to assess a person's health for curing, treating, or preventing such diseases or their consequences. IVDs typically involve the collection, preparation, and examination of specimens from the human body.
In-Vitro Diagnostic Device Import License+
For businesses engaged in importing IVD medical devices into India, obtaining an IVD import license from CDSCO is mandatory. The application process for importing IVD devices can be completed online through the CDSCO Sugam portal, applicable to devices classified as Class A, B, C, and D. The license is issued by the CLA subsequent to evaluating the application and supporting documents, which include GMP certification, CE certification, ISO certification, PMS report, and details of the authorized agent.
Cosmetic Import License+
To import cosmetics from countries like China, Korea, the USA, the UK, etc., a business must obtain a cosmetics import license from CDSCO. Cosmetics encompass substances applied externally to alter, cleanse, or enhance appearance, including any articles used as part of cosmetic products.
Phases of CDSCO Import License Registration for Medical Devices
Phase I – Applicant Registration:
To register as an applicant on the CDSCO portal, clients must maintain an active account on the CDSCO online registration portal. An authorized agent or distributor (holding a wholesale drug license Form 20/21B or registration certificate Form 41/42 for selling medical devices in India) will submit an application for a CDSCO import license for medical devices to the Central Licensing Authority. This application process is conducted through a designated online portal under the Ministry of Health and Family Welfare, Central Government, using Form MD-14.
Procedure of Phase 1
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Online form submission.
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Submission of required document.
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Approval from CDSCO.
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If the application is declined, CDSCO will provide reasons for rejection or advise on reapplication if necessary.
Procedure of Phase 2
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Completion of online form with essential details including device classification, brand name, intended use, product description, etc.
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Uploading documents in accordance with Indian CDSCO regulatory requirements such as regulatory certificates (European CE), free sale certificates, ISO 13485, Plant Master File, Device Master File, etc.
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Payment of CDSCO fees based on product classification.
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Upon successful submission of all documents and fee payment, an application number will be generated along with a copy of the fee challan.
Phase II – Medical Device Import License Application:
An import license application is essential to obtain permission for importing medical devices for commercial purposes.
Phase III – Review from CDSCO
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CDSCO will review the application and verify all uploaded documents. If any queries arise, they will communicate them accordingly.
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Providing relevant justifications or revised documents through the CDSCO online portal.
Phase IV– License Approval
CDSCO will review the justification and verify all documents. If they comply with CDSCO rules, the license will be granted.
FREQUENTLY ASKED QUESTIONS
How to Import a Medical Device into India?
To import a medical device into India, ensure you have obtained the necessary registration certificate and import license. Contact our team for guidance on obtaining a CDSCO import license.
What is the cost of an Import License for a medical device in India?
The cost of a CDSCO/Government import license varies depending on the medical device's risk classification. Contact us to determine the most suitable and affordable licensing process for your device classification.
How can I get an Import License in India?
To acquire an import license in India, start by registering with CDSCO. Our team can assist you throughout the application process, ensuring all requirements are met for a smooth approval process.
Where to apply for medical device import license?
Applications for medical device import licenses are processed through the CDSCO registration online portal under the Ministry of Health and Family Welfare. Ensure your application includes Form MD-14 and all necessary documents for efficient processing.
What is form MD-14 in CDSCO?
Form MD-14 is the essential application form for obtaining an import license from CDSCO. If applying as a foreign manufacturer, ensure it's submitted through an authorized Indian agent or distributor holding a valid wholesale license or registration certificate.
What is a CDSCO MD-15 license?
The CDSCO MD-15 license is crucial for importing medical devices into India, issued by the Central Licensing Authority. It's valid for five years and typically granted to an Indian authorized agent or distributor representing a foreign manufacturer.
