The medical device importer registration under CDSCO in India is very necessary for manufacturers. To enter the Indian market, manufacturers have to fulfill the standards of quality and efficiency to import into India. In India, you are only allowed to import medical devices when you have a medical device importer license under CDSCO.
In India medical devices or products such as Cosmetics, Drugs, Medical Devices, and IVDs are regulated under the provision of the Drug and Cosmetics Act, 1940. So, it is very necessary to obtain a medical device Importer Registration under CDSCO for the manufacturing, distribution, sale & import of commodities. After the registration under CDSCO, you can simply import medical devices into India.
Application Of Import License
Import License Issued By CDSCO
Sales & Distribution License
The full form of CDSCO is the Central Drugs Standard Control Organisation. CDSCO is a national authority that is responsible for the approval and regulation of pharmaceuticals, medical devices, and cosmetics in India. The aim of the CDSCO is to confirm that the medical products available in the market are healthy & safe to use for consumers from the side of manufacturer, sale, distributor, or importer. For approval, you have to apply under the CDSCO registration for Importer Registration of medical devices.
CDSCO stands for Central Drugs Standards Control Organization. It is a regulatory body that issue all kind of license that required to regulate medical device in India.
Read NowCDSCO Medical Device Import License is an authorisation Certificate issued by central Drug Standard Control Organisation (CDSCO) as per Medical device Rule, 2017. It is the primary requirement before starting Import of Medical Devices in India.All medical devices imported into India must adhere to the medical device regulations set by the CDSCO. Obtaining a CDSCO import license is essential, as it grants legal approval, ensuring the products meet the necessary standards for quality and safety.
CDSCO makes all the efforts to ensure that the only safe & effective medical devices enter the market. The list of medical device approvals is very large it includes everything from diagnostic equipment and surgical instruments to medical software.
Medical Device Importer Registration is necessary for all those who are interested in regulating Medical products in the market. The significance of Importer Registration of medical devices are:-
Ensure Quality & Safety
Medical Device Import License is a crucial because it ensures that products imported in market safe & reliable for consumer. It reduce the risk of unsafe products to patients and healthcare providers.
Regulatory Compliance
Certificate ensures that importers comply with the regulatory framework established under the CDSCO department. It work as a document & evidence for the importer during the time of regulatory of products.
Monitoring & Traceability
Through the Importer Registration the CDSCO can track the entry of medical devices in the market. It gives the traceability that the products in the Indian market are approved and ready to use for the consumers.
The medical devices in India are classified into two categories for better understanding during the time of MDR for importers.
When you go for the registration you will find the various classes of medical devices. Each category of medical device have risk and here you will get to know about the classification of risk of Indian medical device for Importer Registration:-
In the Importer Registration of medical devices few regulatory bodies are accountable are as follows:-
ELT Corporate Experts simplify the process of obtaining your Medical Device Importer License under CDSCO regulations. From document preparation to final approval, we guide you through each step to ensure compliance and smooth application processing.
Book a free consultation today to streamline your MD-14 Import License application!
Medical Device Wholesaler & Distributor
Wholesaler can apply for the importer licenses of medical devices under CDSCO.
Medical Devices Manufacturer
The manufacturer can apply for it for sale & distribution but must have Manufacturer License.
Authorized Medical Device Indian Agent
Under the CDSCO act authorized Indian agents can apply for the Medical Device Import License
For the registration of medical device importer license under the CDSCO (Central Drugs Standard Control Organization) in India involves several steps. Here is the further guidelines:
Fill & Submit the Application under MD-42 (Wholesales License for Medical Device) or Form 20B & 21B (Drug Wholesales License) to the respective State Licensing Authority.
Upon the Approval Of Wholesale License apply for the Import License On SUGAM Portal.
After the submission of the application the import license application reviewed by regulatory authority.
Pay the applicable fee for the registration of the license as per the CDSCO guidelines in India. After the payment make sure that you keep the payment receipt as it may be required for the future refrence.
Upon the successful review of the application & any necessary inspections, CDSCO will issue the Medical Device Importer License in India. This will allow you to import devices into India.
When you fill out the form it requires the following information that is necessary to get a medical device FDA importer license in India under CDSCO.
Contact ELT Corporate Experts today! Our team of professionals will guide you through the entire regulatory process to help you secure your MD-14 Import License with ease. We ensure that your application complies with CDSCO standards for a smooth and fast approval.
| License | Fees |
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Class A medical device other than in vitro diagnostic medical device |
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Class B medical device other than in vitro diagnostic medical device |
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Class A or Class B in Vitro Diagnostic Medical Device |
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Class C or Class D Medical Device Other than In Vitro Diagnostic Medical Device |
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Class C or Class D In Vitro Diagnostic Medical Device |
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For the cdsco import license of medical devices following documents are required:-
Medical device cdsco import license is valid for 5 years (Class A, B, C & D) from the date of issue. After the expiration of the Import License, the Importer has to renew the Import license. For renewal there is no need for all documents, only old import licence and fee challan are required.
The timeline for medical device Import License is 6 to 9 months.It vary as per complexity of each steps. If they find any omission in the application or documents then the license time must be delayed. So, Make sure that the application have all the information and documents.
As per the Final notification by CDSCO, if one wants to import a medical device that is class A nonsterile and non-measuring now no longer needs a registration under MD-15. They can proceed with a voluntary registration number which can be obtained with the help of the ELT Corporate Medilaw Team.
ELT Corporate a trusted name in medical device regulatory consulting. We will offer you a comprehensive assistance for importers who are looking for the medical device import license in India. We will guide you through the process of obtaining license that is required for the import of medical devices. With ELT you will experience.:
The MD 15 import license is required for foreign manufacturers wishing to import and sell medical devices in the Indian market.
You must appoint an Indian agent with an MD 42 license. This agent represents you in all dealings with the Central Drugs Standard Control Organization (CDSCO) and helps navigate the regulatory landscape.
You need to legalize a Power of Attorney at the Indian Embassy in your country. This document grants your agent the authority to act on your behalf in India.
It must be drafted in compliance with the Medical Device Rules, 2017, ensuring it meets all regulatory requirements.
This file contains comprehensive details about your medical device, including design, manufacturing processes, and quality control procedures, as per the Medical Device Rules, 2017.
The Site Master File provides detailed information about your manufacturing facility, including equipment, personnel, and quality control systems.
A predicate device is a similar medical device that has already been approved in India. Providing details of a predicate device can expedite the approval process for your product.
Yes, you need to submit a biocompatibility or evaluation report. If these reports are not available, you must provide a justification.
For Class C and Class D devices, you must obtain a free sale certificate from countries like Australia, Canada, Japan, EU member states, or the USA, as these devices require more stringent documentation.
No, you cannot import a medical device into India without the import license
You must document any “post-approval changes,” such as new features or adjustments made to the device. This ensures that your license remains up-to-date and secure.
To renew your license, you need to pay the renewal fee and submit the payment deposit slip. If applicable, include any late fees.
A Free Sale Certificate/Marketing Authorization is a document issued by the National Regulatory Authority in your country that confirms your medical device is approved for sale. You must upload a valid Free Sale Certificate from your country or from the USA, EU, UK, Canada, Japan, or Australia.
Yes, if you wish to exclude any device from renewal, you must provide a valid reason for the exclusion.
Failing to include details of post-approval changes can jeopardize the validity of your license and may lead to compliance issues.
