Step-by-Step CDSCO Import License Process for Medical Devices in India

India is the witness of a sharply growing domestic medical device manufacturing industry. A significant portion of imports is also highly affecting the Indian market image. With the increased demand, the foreign manufacturers are showcasing their interest in trading in India. With the increase in demand, the national regulatory authority has implemented strict rules and regulations. 

It means, for the medical importation, securing the CDSCO license is crucial. But navigating the CDSCO registration process alone can seem daunting. However, the right guidance and support can streamline the registration hurdles. This guide will explore the comprehensive CDSCO medical device license approval steps, with regulatory authority requirements and many more. Let’s explore it in more detail.

What is the CDSCO Import license for Medical Devices?

The regulatory authority, the Central Drugs Standard Control Organization, not only issues the medical device license but also approves new devices. In addition, the CDSCO medical device for importers is the license issued in Form MD-15. The license is the golden key that allows manufacturers to sell their products legally in Indian markets. The CDSCO certification is required to ensure that the device has met specific safety and quality standards. CDSCO is governed under the Medical Devices Rules 2017, which monitor imports of medical devices. The significance of the CDSCO import license lies in its role to ensure the safety and quality standards of medical equipment prior to its importation into India. With registration, the authority gets access to the tracking, which is essential for public safety. 

The Key Features of the CDSCO Medical Device

The license for importing medical devices is required to ensure regulatory compliance. The medical device manufacturing certification involves equipment testing to verify the safety standard and further provides legal market access to operators. The major considerations for it are

Risk-Based Classification

The medical equipment is categorized into its risk factors, such as Class A, B, C, and D. With different devices, the requirements and registration form are also different.

Manufacturing Standard

The guidelines of the regulatory authority, CDSCO, have highlighted the clear manufacturing standards for devices. The standard is required to ensure that the equipment has met specific safety and quality benchmarks. 

Details Review

To ensure compliance with standards, CDSCO oversees the technical and regulatory information. Through it, they verify that the equipment is safe and effective for use.

Post-Market Surveillance

Getting the license is meant to adhere to ongoing compliance to transparently monitor the device performance and safety parameters.

CDSCO Medical Device for Import Process in India

Multiple steps are involved to obtain a CDSCO medical device import license in India. These steps are 

Step 1: Device Classification

Determine the class of your devices on the basis of their risk factor. Select whether your device falls into Class A, B, C, or D, based on its intended use and potential risk. 

Step 2: Registration Online

The selected application is required to be submitted to the CDSCO online platform. Before submission, the importer is required to create an account by mentioning a valid mobile number and email ID.

Step 3: Document Submission

Essential documents must be submitted and included with the application. The supported documents are:

• Need for Form MD-14, the import license application
• Device Master File and Plant Master File
• For quality management system compliance, the ISO 13485 certificate.
• Free Sale Certificate (FSC) from the country of origin.
• If required, the CE Certificate or Declaration of Conformity 
• Power of Attorney (if applicable)
• Other relevant technical documentation, safety reports, and performance reports

Step 4: Application Review

The submitted application will be scrutinized by the CDSCO official. They verify whether the application is complete or not with accuracy in the submitted documents. With the rise of queries, provide any additional details. 

Step 5: License Approval

Following the successful verification of the medical device application, the CDSCO will issue an MD-15 license (import license). It provides market access for you to sell equipment.

Step 6: Post-Market Surveillance

Need to manage the manufacturing process of medical devices accurately, including reporting any adverse events related to the equipment. Must ensure ongoing compliance with regulations.

Conclusion | CDSCO Medical Device Import License

By issuing the CDSCO import license, the regulatory authority gains access to ensure compliance with safety and quality standards before the product enters India. To navigate the CDSCO online registration process for medical devices, importers are required to fulfill the authority requirements. It involves preparing the MD-14 application with supporting documents and registration with CDSCO (Central Drugs Standard Control Organization). For a more seamless registration process for medical devices for importers, get in touch with an expert at LegalRaasta Pvt Ltd. 

Frequently Asked Questions

1. How can I get a CDSCO medical device import certificate?

Ans. To secure a CDSCO certificate for equipment, register with the relevant authority (e.g., the Central Drugs Standard Control Organization) and gather the specified certificates.

2. What’s a CDSCO test license?

Ans. The CDSCO test license for medical devices is obtained by the manufacturers or importers. With it, the manufacturers can design or import equipment in small quantities for the purposes of testing.

3. Which application form is necessary for the test application?

Ans. Form MD-12 is necessary for obtaining a test license to manufacture medical devices.

4. What is the use of Form MD-13?

Ans. The test license to the manufacturers is provided in Form MD-13.

5. In which form is the import test license issued?

Ans. The test license for the import of medical devices is issued in Form MD-17.