Are you planning to import medical devices into India? The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices being imported into India. Hence, you will have to secure the CDSCO import license. We have prepared a checklist for MD 15 license application to help you navigate the CDSCO import license application process. Additionally, we have provided a detailed list of documents required for CDSCO MD-15 license application.

India’s domestic medical device manufacturing market is significantly growing. Indian medical device market is focussing on manufacturing high-quality affordable and accessible medical devices. However, India still heavily depends on imported medical devices to fulfil its healthcare sector needs. Thus, medical device companies have to import most of the high-end lifesaving medical devices. Given the critical role of medical devices in diagnosing, monitoring, and treating patients, their quality and efficacy will have to be strictly regulated. It is vital that substandard medical devices are not being imported into India, as it will affect the quality of healthcare delivered. Hence, CDSCO has formulated stringent guidelines for importing medical devices into India.

License required for importing medical devices into India

It is mandatory to obtain the CDSCO medical device import license for importing medical devices for sale and distribution in India.

• Form MD 14: To import medical devices into India, an application has to be filed under Form MD 14.
• CDSCO MD 15 license: The license for importing medical devices into India is granted under CDSCO MD-15. MD 15 license is a mandatory requirement for importing all Class A (measuring and sterile) B, C, and D medical devices.

Comprehensive checklist for MD 15 license application

Imported medical devices will have to meet Indian and international quality standards. Hence, you will have to comply with Indian regulatory guidelines for imported medical devices to launch your products in India. Complying with the Indian medical device regulatory guidelines to secure the CDSCO MD 15 license can be overwhelming. Navigating multiple regulatory requirements and criteria can be cumbersome. Hence, we have prepared a comprehensive checklist for MD 15 license application. You can refer to our checklist for a smooth CDSCO MD 15 license application journey. Notably, the guidelines for new CDSCO import license application, endorsement of additional devices, and retention of an existing MD 15 license vary slightly. Hence, we have prepared different checklist for different scenarios.

Checklist for MD 15 license application

To apply for a new MD 15 license, you need to file the application on form MD 14. For which certain documents have to be prepared. Additionally, compliance with CDSCO regulatory guidelines and criteria is mandatory.

1. A detailed application overview on covering letter 
2. Complete import license application on Form MD-14
3. Fee challan as a proof of payment
4. Wholesale/manufacturing license as a proof of authorization
5. Constitution details of the authorized agent
6. Manufacturing site registration and audit report details
7. Quality Management System (QMS) Certificate
8. CE certification or equivalent
9. Plant Master File 
10. Device Master File providing device specifications, clinical data, safety compliance information, and risk analysis report
11. Power of attorney to be authenticated by relevant authorities in India or abroad
12. Free Sale Certificate from the country of origin, such as the US, EU, or Japan

Checklist for retaining existing CDSCO import license

You will require the following for the retention of the existing CDSCO import license:

1. Retention form
2. Fee challan
3. A copy of the existing CDSCO import license 
4. Valid Free Sale Certificates and any other Quality Certificates.
5. An undertaking confirming no changes in the Device Master File or Plant Master File has been made, unless they have been updated
6. Post-marketing surveillance data that should include complaints and recalls

Checklist for endorsement application for additional devices

To endorse additional devices to an existing CDSCO import license, you will need the following:

1. Submit a fresh Form MD-14
2. Provide updated regulatory certificates and any other quality certificates
3. Ensure the Device Master File mentions the accurate grouping and specifications for the new devices
4. Power of Attorney
5. Include the existing CDSCO import license

List of documents required for MD-15 license application

1. Overseas manufacturing site registration document: A registration document of the overseas manufacturing site issued by the competent authority in the country of origin is required. This notarized copy of the document will verify the plant is registered and authorized to manufacture medical devices. 
2. Free sale certificate: A free sale certificate indicates the device is legally sold or distributed in the country of origin. Thus, a notarized free sale certificate forms an important part of the documents required for MD-15 license application. Additionally, a marketing authorization from the National Regulatory Authority of the manufacturer’s country will also be required.
3. ISO 13485 certificate: An ISO 13485 certificate reflects the manufacturer’s compliance with international standards for medical device quality management systems. Hence, a notarized copy of the ISO 13485 certificate is a vital document for CDSCO MD 15 medical device import license application.
4. Full quality assurance certificate: Full quality assurance certificate, CE type examination certificate, and CE product quality assurance certificate are also some of the documents required. These certificates demonstrate the medical device’s conformity to European Union safety, health, and environmental protection standards. 
5. Inspection or audit report: A copy of the most recent inspection or audit report is required. This report validates the manufacturing site complies with relevant quality standards. The audit should have been conducted by a Notified Body, National Regulatory Authority, or any other Competent Authority. This report should be recent i.e., prepared within the last three years.
6. Declaration of conformity: A declaration of conformity demonstrates the device complies with applicable regulatory requirements and standards. The manufacturer is required to submit a notarized declaration of conformity.
7. CE design certificate: A notarized copy of the CE design certificate is required. This certificate is crucial to demonstrate the medical device’s design meets EU safety requirements.
8. Power of attorney: Power of attorney is one of the crucial documents required for MD-15 license application. This document is needed to designate an authorized agent who will handle the import process on behalf of the overseas manufacturer. Moreover, it must be authenticated in India by either a first class magistrate, the Indian Embassy in the country of origin, or an equivalent authority through an apostille process. Furthermore, the power of attorney must be accompanied by an undertaking from the authorized agent. This undertaking confirms the responsibility of the authorised agent for compliance with the CDSCO regulations for medical devices.
9. Constitution details of authorized agent: The domestic authorized agent’s constitution details have to be submitted. This document is required to verify the authority and legal structure of the agent representing the manufacturer in India. 
10. Device master file (DMF): The device master file is used to demonstrate the medical device is safe and effective for the Indian market. The DMF includes medical device details, such as design specifications, manufacturing process, and safety and performance evaluations. Hence, this document is of critical importance in CDSCO MD 15 medical device import license application.
11. Plant master file (PMF): The plant master file helps regulatory authorities assess the manufacturing site’s compliance with safety and quality standards. This document includes facility layout, production process, and quality control measures. Hence, the PMF forms a pivotal part of the documents required for MD-15 license application.
12. Valid manufacturing license: A self-attested copy of the valid manufacturing license is required. The valid manufacturing license will prove the device has been manufactured as per regulatory requirements of the country of origin. Furthermore, the self-attestation ensures the document’s authenticity.

Pharmadocx Consultants: Your trusted CDSCO import license consultant

We have prepared a checklist for MD 15 license application to help you navigate the import license application process. However, the import license application process can be cumbersome, requiring extensive knowledge of the CDSCO guidelines. We at Pharmadocx Consultants will ensure you have a streamlined CDSCO MD 15 license application process. Additionally, we provide document preparation support for CDSCO license application. Simply get in touch with us at [email protected] or call/Whatsapp on 9996859227.