The CDSCO MD 15 license is granted for importing medical devices into India. It is the gateway for importing and selling imported medical devices in India. MD-15 license is a mandatory requirement for importing all Class A (measuring and sterile) B, C, and D medical devices. Supporting documents have to be prepared and submitted along with the CDSCO MD 15 medical device import license application. Notably, each document has a crucial role in demonstrating compliance with regulatory standards and quality benchmarks. By submitting these documents, the importers can demonstrate their medical devices meet stringent safety, performance, and quality requirements. The primary aim of these documentations is ensuring improved patient safety and outcome in India. Moreover, accurate and correct documentation per guidelines will facilitate smooth regulatory approval. In this blog, we have discussed the documents required for MD-15 license application.

CDSCO license for importing medical devices into India

The CDSCO regulates the import of medical devices into India. Hence, you have to secure the CDSCO medical device import license to import your medical devices for sale and distribution in India.

• Form MD 14: Form MD 14 is the application form for securing the medical device import license. 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. Various supporting documents required for MD-15 license have to be submitted along with the license application. Notably, CDSCO has recently notified class A non-measuring and non-sterile devices will not require a medical device import license. However, they will require a CDSCO medical device registration. The CDSCO MD 15 license remains valid indefinitely unless cancelled or suspended. However, the license retention fee must be paid every 5 years from the date of issuance. If the license retention fee is not paid within the stipulated period, the license will be deemed cancelled.

Who can apply for the CDSCO MD 15 medical device import license?

• Any wholesaler or importer who wants to import any medical devices for sale and distribution in India
• Any foreign medical device manufacturer who wants to supply medical devices in India. However, the foreign manufacturer will have to appoint an Indian authorised agent. The authorised agent will act on behalf of the manufacturer and file the application.
• Any research institution in India who wants to import medical devices for clinical trials and research.
• Any hospital or healthcare provider who wants to import specialized medical devices, testing devices, or custom-made devices for their patients.
• An importer of special rapid test kits.
• An Indian authorized agent who has a valid wholesale license for the sale or distribution of medical devices.

What are the documents required for MD-15 license application?

The medical device import process is strictly regulated by CDSCO to ensure all imported devices meet quality and safety benchmarks. Hence, obtaining the CDSCO import license is a mandatory requirement for importing medical devices into India. Thus, MD-15 license applicants are required to submit several critical documents demonstrating evidence of compliance with regulatory guidelines. We have listed the documents required for MD-15 license application.

List of documents required for MD-15 license application

1. 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.
2. 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. 
3. 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.
4. 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.
5. 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. 
6. 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.
7. 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.
8. 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.
9. 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.
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. 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. 

Pharmadocx Consultants: MD-15 License Application Document Preparation Service

Each document has to be prepared and compiled as per CDSCO guidelines. We have provided an overview of the documents required for MD-15 license application. For a detailed list of documents and guidance on document preparation feel free to reach out to us. Furthermore, you can avail our CDSCO medical device import license application document preparation service. Our team of seasoned experts will prepare and collate all the necessary documents as per CDSCO guidelines. Preparing the necessary documents for CDSCO MD 15 license application is a mammoth task. With the support of our experts, this process can be a breeze for you. Drop an email at [email protected] or call/Whatsapp on 9996859227 to avail our CDSCO MD 15 license application document preparation service.