What are CDSCO Form MD 26 and 27 and the benefits of having the import license for new medical devices?

CDSCO Medical Device Import License – In India, the Central Drugs Standard Control Organization (CDSCO) governs the Import License for Medical Devices.  The national regulatory authority responsible for ensuring the safety, efficacy, and quality of drugs and medical devices. Additionally, to legally introduce a new medical device into the Indian market, manufacturers or importers must obtain an import license through a structured process. This process involves submitting applications via CDSCO Forms MD 26 and MD 27.

Moreover, Form MD 26 acts as the initial application for devices without a predicate in the Indian market. while Form MD 27 provides the final approval from CDSCO, granting permission to import, sell, and distribute the device. This regulatory framework not only ensures adherence to safety standards but also validates the quality and intended use of medical devices. However providing credibility and legal compliance for companies seeking to operate in India’s rapidly growing healthcare sector.

What is CDSCO Forms MD 26 and MD 27?

The Central Drugs Standard Control Organization (CDSCO) regulates the import and distribution of medical devices in India. Additionally, Forms MD 26 and MD 27 are integral parts of obtaining an import license for new medical devices.

Form MD 26:

Purpose: It is the application form that a company must submit to the CDSCO to seek approval for importing medical devices that do not have a predicate (previously approved equivalent) in the Indian market.

Role: Moreover, Acts as a formal request to CDSCO to assess and evaluate the new medical device for import approval.

Form MD 27:

Purpose: It is the permission form or license issued by CDSCO after the successful evaluation and approval of the Form MD 26 application.

Role: Furthermore, this form grants the company permission to legally import, sell, and distribute the medical device in India.

Aspect Form MD 26 Form MD 27
Purpose Application form for importing a new medical device Permission/license issued to import the device
Usage Submitted by the importer to CDSCO for approval Issued by CDSCO to the importer after approval
Role Initiates the application process Concludes the process by granting the import license

 

What Is the Difference Between MD 26 and MD 27?

The main difference between MD 26 and MD 27 lies in their roles in the Import License for Medical Devices process. Additionally, MD 26 is the application form submitted to CDSCO to initiate the process for importing medical devices without a predicate in India.

Moreover, In contrast, MD 27 is the actual approval form granted by CDSCO, providing permission for the device’s import, sale, or distribution. Together, they complete the Import License CDSCO procedure, ensuring compliance and safety standards.

Benefit of CDSCO Medical Device Import License

The benefit of obtaining this CDSCO Medical Device Import License is that it ensures imported medical devices meet high safety and quality standards before entering the Indian market. Additionally, the license confirms that the product has undergone extensive validation and quality assurance testing in authorized laboratories.

Moreover, this certification by CDSCO ensures that the device is safe, reliable. It also ensures its suitability for its intended use, providing confidence to healthcare professionals and patients regarding the device’s performance and efficacy.

Who Can Apply for a New Medical Device Import License (MD 26/27)?

An Authorized Indian Agent with a valid license to manufacture, sell, distribute, or wholesale medical devices can apply for the New Medical Device Import License (MD 26/27). Additionally, applicants must complete the Medical Device Registration on Portal, the official CDSCO online system, to initiate the process. Moreover, as per CDSCO guidelines, this agent acts on behalf of foreign manufacturers to ensure compliance with Indian medical device regulations.

Furthermore, engaging a Medical Device Consultant India is highly beneficial, as they provide expert guidance on preparing documentation, meeting regulatory requirements, and navigating the application process efficiently.

Subsequently, these consultants ensure accurate classification, documentation, and submission, helping to secure approval from the Central Licensing Authority (CLA) quickly. Therefore, this streamlined approach minimizes errors and accelerates obtaining the import license. It makes the process smoother and more efficient for applicants.

Procedure for Applying for an Import License for New Medical Devices

The procedure for applying for an Import License for New Medical Devices involves several key steps:

  • Evaluate the Product: Ensure the medical device complies with Indian Medical Device Rules (MDR) 2017.
  • Classify the Product: Additionally, determine the risk category of the device (Class A, B, C, or D) as per Indian regulations.
  • Prepare Documentation: Gather documents as per the checklist in Form MD 26. It includes technical specifications, safety data, clinical evaluation, and manufacturing details.
  • Appoint an Authorized Agent: Moreover, appoint an authorized Indian agent if you are a foreign manufacturer.
  • Online Registration: Complete the Medical Device Registration on Portal via the CDSCO’s online system and submit the application.
  • Pay Fees: Pay the required government fees for the application.
  • Review & Approval: Furthermore, CDSCO reviews the application and, if satisfied, grants the import license.
S.No. Procedure Details/Requirements
1 Check Device Classification Verify the classification of the medical device according to national regulations.
2 Prepare Required Documents Collect all necessary documents, including:
Duly filled application form
Device specifications and testing reports
Regulatory compliance certificates (e.g., CE/FDA approvals)
Free Sale Certificate from the country of origin
3 Submit Application Online Register and submit the application through the national regulatory authority’s online portal.
4 Pay Application Fee Pay the required fee, which varies based on the device classification. Ensure the payment receipt is attached to the application.
5 Review by Regulatory Authority The authority reviews the application, checks for completeness, and may request additional information or documents.
6 Inspection & Verification The authority may inspect the manufacturing site or request samples for testing and verification.
7 Approval or Rejection If the device meets all regulatory requirements, the authority grants the import license. If rejected, they provide reasons and allow for resubmission.
8 License Issuance Upon approval, the import license is issued, allowing the applicant to import the medical device legally.
9 Post-Approval Compliance Maintain compliance with regulatory requirements, such as periodic audits, reporting adverse events, and renewals as needed.

How a Medical Device Consultant Like “Vaayath” Can Assist with the Application Process?

A medical device consultant like Vaayath can greatly assist with the application process for a CDSCO Import License for new medical devices. It provides expert guidance and support at every step:

  • Regulatory Expertise: Vaayath offers deep knowledge of CDSCO regulations. It ensures your application complies with all legal requirements for Forms MD 26 and MD 27.
  • Document Preparation: Additionally, we help in gathering, preparing, and reviewing the necessary documents. It includes technical specifications, clinical evaluations, and quality assurance details, ensuring completeness and accuracy.
  • Product Classification: Vaayath assists in correctly classifying your medical device. These devices are based on risk categories (Class A, B, C, or D), which is important for a smooth application.
  • Online Registration Support: Moreover, we guide you through the Medical Device Registration on Portal, simplifying the online submission process.
  • Authorized Representation: If you’re a foreign manufacturer, Vaayath can act as your authorized Indian agent, representing your interests before CDSCO.
  • Fee Management and Payment Assistance: We ensure timely and accurate fee submission.

Conclusion

Vaayath offers follow-up support, addressing customer queries and ensuring compliance until the license is acquired, making the entire process easy. So contact us today!

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